Comparative Study of the Response to Weight Loss and Metabolic Conditions Using Two Non-pharmacological Nutritional Programs
Phase: NA
Conditions: Obesity
Sponsor: Universidad Veracruzana

 
Universidad Veracruzana 
Health Sciences Institute 
 
 
Comparative study of the response to weight loss and 
metabolic 
conditions 
using 
two 
Nonpharmacological 
nutritional programs. 
Ze 2021-001 V 2.1 
 
 
 
 
 
 
Principal Investigator:   
 
Dr. Francisco J. Nachón García.  
fnachon@uv.mx  
 
 
Co-Investigators:  
 
 
L.N. Gabriela Enriqueta Saldaña-Dávila  
gabriela@zele.mx  
Mexico City, April 23, 2021 
 
 
 
 
 
 
 
 
 

1. INTRODUCTION  
 
Obesity is a chronic disease characterized by an excessive body fat accumulation, which has a 
negative impact on health and affects the physical, social and emotional wellbeing. A double-blind 
study will be carried out using a weight loss program based on a low-fat, normoprotein, controlled 
ketogenic diet, followed by a metabolic adaptation process. During the weight loss process, psycho-
emotional support and personalized physical activity supervision will be provided in order to modify 
lifestyle habits along with nutrition. In this study, supervision during 24 months of the weight lost is 
proposed to ensure the stability of the results obtained. In the initial phase where the diet process 
is fully controlled, the control group will receive the weight reduction program proposed by the 
WHO task force.  
 
The weight loss program is developed according to the characteristics of each patient and includes 
medical control, dietary-nutritional supervision, introduction of a physical activity program and 
psycho-emotional support.  
 
The primary objective of this study is to test the effectiveness, safety and security of this intervention 
method for weight loss and compare it with a conventional method for weight loss.  
 
This document includes all the background information for the use of the so-called very low-calorie 
ketogenic diet, the hypotheses to be tested in this study, the methodology of how the objectives will 
be demonstrated and the statistical analyses used, the table of variables to be studied, the 
bibliography consulted and finally the materials used for data collection and management. 
 
 
 
 
 
 

2. BACKGROUND.  
 
Obesity is a chronic disease characterized by an excessive accumulation of body fat, which impacts 
health negatively and affects the physical, social and emotional wellbeing. It is a growing health 
problem with a high prevalence worldwide and a high impact in Mexico (1). According to a study 
conducted by the Food and Agriculture Organization of the United Nations (FAO), Mexico has 
become the country with the highest obesity rate, with 32.8% obese people, above the United 
States with 31.8% (2), such data definitely underestimates the problem in Mexico, since according 
to the National Health and Nutrition Survey (ENSANUT) 2018, 42.5% of men over 20 years old are 
overweight and 30.5%, are obese; while in women these figures correspond to 36.6 and 40.2%, 
respectively (3).  
  
Higher total energy intake and sedentary lifestyles are most immediate contributors for the increase 
in the number of people with obesity. This is mainly attributed to an increase in the consumption of 
refined sugars, and to the consumption of a greater variety of foods with high energy content, 
without leaving aside the increase in commercial portions consumed (4).  
 
The increase in the prevalence of obesity represents a growing public health risk, since obesity is 
not only an aesthetic problem or a body image appreciation problem, but also has a direct impact 
on health. Obesity is the underlying pathology of many chronic diseases, especially those related to 
lipid metabolism such as dyslipidemia, metabolic syndrome, or coronary and vascular diseases. In 
addition, obese patients also face other pathologies derived from weight gain, such as sleep apnea 
or osteoarticular disorders (5).  
 
To effectively treat obesity, three goals must be met: to lose weight, to maintain the new weight, 
and to not regain the lost weight. The achievement of these goals is fundamentally based on three 
pillars: patient motivation, individualization of treatment, and realistic goals. Motivation is 
important because it has been proven that unmotivated patients show low adherence to the diet. 
(6) Treatment must be individualized, according to the patient's lifestyle and food preferences. For 
that purpose, it is necessary not only to regulate the diet, but also to encourage physical exercise 
and, if necessary, use medication. Setting realistic goals, agreed with the  patient, allows the patient 
to become involved with the diet and facilitates adherence to it. (5).  

Nowadays, there are a large number of diets available to treat and control obesity. One of the most 
commonly used by nutritionists is the hypocaloric diet. This type of diet consists of a daily caloric 
intake around 10% lower than the patient's basal metabolism, which normally represents an intake 
of between 800 and 1,500 kcal per day. To achieve this, in hypocaloric diets the consumption of the 
basic nutrients required by the body is reduced in a balanced way, maintaining their proportions: 
between 25% and 35% of fats, between 50% and 65% of carbohydrates, and between 10% and 20% 
of proteins. This type of diet has proven to be effective in short-term weight loss, but not in 
maintaining the weight loss (7). The possible causes of the low efficiency of hypocaloric diets in the 
long term are the lack of adherence to this type of diet, and the reduction of basal energy 
expenditure (4).  
 
Due to the ineffectiveness of hypocaloric diets in the long term, a large number of diets have been 
developed that are based on the intake of different percentages of macronutrients that seek to 
optimize weight loss, especially in the long term. Among them is the protein diet, developed by 
Blackburn in 1976. This diet results in weight loss through a protein-rich diet and reduced intake of 
lipids and carbohydrates. In addition, as a consequence of the nutritional imbalance, the patient 
should receive supplementation with vitamins and minerals to ensure the supply of the 
micronutrients required by the body (8). The basis of the protein diet is the reduction of 
carbohydrate intake to a minimum. This ensures that in a 48-72 hour period, the body resorts to 
fats as an energy source, and ketone bodies are formed so that stored lipids are used as a source of 
energy. Studies on the efficacy of the ketogenic diet with very-low carbohydrate, high-protein and 
reduced lipid content show that it produces, not only a very rapid decrease in the weight of patients 
in the short term, but is also effective in the long term (9, 10).  
 
So far, different variants of Blackburn's protein diet have been developed. Among them is the 
multidisciplinary Zélé program which, like the rest of the high-protein diets, is based on maintaining 
protein intake according to the calculated requirement, while reducing lipids and carbohydrate 
intake. However, this method does not only consist of weight loss by means of controlled ketosis, 
but also by patient re-education to promote changes in eating habits. . This program must be carried 
out under the supervision of a multidisciplinary group that includes a physician to control the 
possible side effects of ketosis, a nutritionist to supervise the nutritional habits and conditions, a 

psychologist to strengthen and help maintain the patient's motivation for weight loss, and a physical 
trainer to adapt a personalized program for the preservation and strengthening of muscle mass.  
The Zélé method consists of five stages: frank ketosis stage, mixed ketosis stage, transition stage, 
integral stage and maintenance. The ketogenic stage, in which a high-protein diet with high 
biological value (HBV) proteins is followed, supplemented with vitamins and minerals. In this stage, 
the expected weight is reduced by 70 to 80%, divided into frank ketosis and mixed ketosis, with a 
variable duration depending on the patient's initial weight and the kilograms to be lost, although for 
the purposes of the study a duration of between two and three months is proposed. In the transition 
stage, carbohydrates are incorporated with the purpose of leaving the metabolic state of ketosis. 
Later, in the integral stage, carbohydrates, natural proteins and fats are progressively incorporated, 
instilling in the patient the habits to achieve a balanced diet. In this stage, a loss of between 20% 
and 30% of the remaining excess weight is sought. Throughout the maintenance stage, with a 
supervised duration of two years, the patient is followed up and monitored to maintain the weight 
loss, with the advice of a team of dietitians and nutritionists.  
 
The studies carried out to date with diets that are very-low in carbohydrates, high-protein and low 
in fat have demonstrated their efficacy in reducing weight both in the short and long term (9,10). 
There is increasing evidence that rapid weight loss, such as that achieved with this type of nutritional 
intervention, is associated with better long-term results, and initial weight loss has even begun to 
be considered as a predictor of long-term weight maintenance.(11,12,13,14) Furthermore, in 2012, 
George Blackburn himself acknowledged in an article that the tendency to use commercial rapid 
weight loss programs is appropriate, since they achieve better results.(15,16,17.)  
 
The anecdotal experience obtained in daily practice with the Zélé method and products has shown 
great effectiveness in weight reduction, however, so far there is no scientific evidence of its efficacy 
or its medium and long term effects. By conducting a double blind study, our objective is to evaluate 
the efficacy and safety of this nutritional intervention for the reduction and maintenance of weight 
loss, due to the fact that it is possible, according to Zélé's food engineering system, to build a reduced 
carbohydrate diet under the same concept of Zélé's products for a controlled ketogenic diet, as well 
as to perform a 12 and 24 months follow-up of the cohort to assess its efficacy not only in the initial 
stages, but also during the 24-month follow-up. The aim of this study is also to evaluate patient 
adherence to treatment, which in most studies reports a dropout rate of over 40% (4). In addition, 

the characteristics of weight loss and the preservation of muscle mass and strength and finally 
patient satisfaction with their treatment will be evaluated. 
3. PROBLEM STATEMENT  
 
Obesity is one of the biggest pandemics in human history. According to the WHO, in 2016, more 
than 1.9 billion adults aged 18 or older were overweight, of which, more than 650 million were 
obese. Overweight and obesity are defined as an abnormal or excessive accumulation of fat that 
can be detrimental to health.  
 
Until the end of the 20th century, the health problems of the population in developing countries 
were related to their nutritional status, especially stunting in children and anemia in women of 
reproductive age. But all that has changed in just a few decades; the world has gone from a 
nutritional profile in which the prevalence of undernutrition more than doubles that of obesity, to 
the current situation in which there are more obese people in the world than underweight people.  
Obesity and overweight, once considered characteristic of affluent societies, are now on the rise in 
low- and middle-income countries, especially in urban areas, where the increase is particularly 
marked.  
 
This evolution toward obesity affecting the entire population is occurring at a frightening speed. In 
Mexico City, for example, obesity in the urban adult population has risen from 16% in 2000 to 35.6% 
in 2018. By then, the urban child population between 5 and 11 years old with obesity or overweight 
had already reached 35%. As for the country as a whole, it is estimated that currently seven out of 
ten Mexicans are overweight and that one third of those affected can be considered medically obese 
(ENSANUT 2018). Obesity increases the risk of diabetes mellitus, cardiovascular diseases, 
obstructive sleep apnea-hypopnea, and some types of cancer are within the group of conditions 
that have shown a direct association. Currently, the condition in which obesity, as an independent 
risk factor, has the greatest impact is type II diabetes mellitus with its costly complications, such as 
blindness, amputation of limbs and the need for dialysis, so finding a method accessible to the 
general population that achieves the reduction or control of obesity rates could have an impact on 
the reduction of cases of obesity that progress to DM-II and thus even have an impact on the 
national health budget.  

Therefore, we ask ourselves if a structured multidisciplinary program based on a normoprotein 
ketogenic diet low in fat and carbohydrates is effective, safe for short-term weight loss and allows to 
maintain weight loss in the long term. 
 
4. JUSTIFICATION  
 
Overweight and obesity have been associated with an increased risk of multiple diseases including 
cardiovascular conditions and DM-II. If a person already has type 2 diabetes and gains weight, it will 
be even more difficult for him or her to control his or her blood sugar level.  
 
In Mexico we do not know the current status of cardiovascular diseases associated with obesity, but 
in relation to DM-II presents high incidence in the population, in this regard the National Health and 
Nutrition Survey (ENSANUT) in 2018 revealed that approximately 8.6 million Mexicans have diabetes 
mellitus, which we can associate with the increase in the rates of overweight and obesity, which in 
children aged 5 to 11 years is 35.6%, from 12 to 19 reaches 39.7% and in the adult population over 
18 years 76.8% in women and 73% in men, which represents an increase of at least 3% between 
2012 to 2018. As commented, obesity and overweight is one of the most important risk factors for 
triggering Diabetes Mellitus. Good nutrition is an indispensable tool for the good control of all 
chronic degenerative diseases such as diabetes. Nutritional management is one of the determining 
factors to improve the control of many of these chronic degenerative diseases, mainly DM-II and 
hyperlipidemia. It is imperative to mention that diabetes is one of the main causes of death and the 
tendency is that the figures continue to increase due to the high rates of obesity and sedentary 
lifestyle in the world. The implementation of diets that help to reduce weight will favor the control 
and improve the quality of life of these patients, since it will reduce the risk of complications, and 
will also help to improve their self-esteem and avoid depression. The results obtained in this study 
are expected to be disseminated in research forums and scientific journals, as well as a technical 
report for the company that finances the project.  
 
The direct benefits provided to the study population will be close monitoring of their clinical and 
metabolic evolution, awareness of their nutrition and how it impacts their health. There is no 
evidence of risk compared to the benefit that the rapid and safe reduction will provide to the study 

population and to all those subjects who will be managed in the future with the proposed nutritional 
intervention. 
5. OBJECTIVES  
 
5.1 General Objective  
 
To evaluate differences in the response of weight, body composition and metabolic 
biochemical parameters among obese patients following a normoprotein low-fat controlled 
ketogenic diet compared to a balanced BIEM). 
 
  
5.2  Specific Objectives 
 
• 
Intra- and intergroup comparison of patient weight and BMI reduction between baseline and 
subsequent follow-up monitoring visits.  
• 
To determine the percentage of patients with weight loss equal to or greater than 10% of initial 
weight and the time it took for patients to reach this figure.  
• 
Evaluate the evolution of comorbidities associated with obesity (HT, hyperglycemia or diabetes, 
hypercholesterolemia, hypertriglyceridemia, apneas), control of clinical and analytical 
parameters and changes in medication during the weight loss process and during follow-up.  
• 
To know the tolerability of the diet: Incidence of side effects during the development of the 
study,  
• 
Safety of the intervention diet: appearance of analytical alterations, especially of the ionic 
profile, renal function and hepatic function, incidence of serious adverse events.  
• 
Assess diet adherence and dropout rate and cause.  
• 
To know patient satisfaction with the assigned nutritional program.  
 
 
 

6. HYPOTHESIS  
 
Assumption 1: Weight Loss .  
H1: The use of the "Zélé method" (Tx1) allows a greater weight loss (pp) than a hypocaloric diet 
(Tx2) in the same time (t).  
Assumption 2.  
H2: Tx1 is safe and with low or no adverse effects.  
Assumption 3. Metabolic conditions  
H3: pp with Tx1 allows the regulation of metabolic syndrome and its components. 
H4: The state of controlled ketosis that occurs with Tx1 does not change pH or raise blood lactate 
levels.  
Assumption 4 . Body Composition.  
H5. Tx1 will produce a selective loss of fat and preservation of muscle mass. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

7. METHODOLOGY  
 
7.1. Study setting.  
 
The study will be conducted in Mexico City under the sponsorship of Zélé® and in collaboration with 
the VIME Weight Loss and Wellness Center of Mexico. During the year 2021 and with follow-up for 
24 months. An open call will be made through different media including social networks for the 
recruitment of patients who meet the inclusion criteria and must present themselves for a clinical 
evaluation in which pathological history, clinical status, heart rate, blood pressure, oxygenation and 
temperature will be recorded. Nutritional assessment in which anthropometry and multifrequency 
electrical bioimpedance analysis (MFBIA) will be performed to determine body composition. 
Patients will have to bring a Complete Blood Count, a biochemical profile that includes the following 
determinations: Fasting blood glucose, glycosylated hemoglobin, urea, creatinine and uric acid, 
cholesterol, triglycerides, LDL, HDL and VLDL, direct and indirect bilirubins, alanine and aspartate 
aminotransferases, gamma-glutamyl transferase and albumin, determination of serum electrolytes 
sodium, chloride, potassium, magnesium, phosphorus and calcium, Fasting Insulin , HOMA index 
calculation. In addition to a thyroid function panel and arterial blood gases. They will be instructed 
during recruitment for the studies to be performed in a clinical laboratory, under the current 
standardization and with standardized and perfectly calibrated automated equipment, and a request 
will be made to keep the vials of the patients' plasmas. Patients who meet all the inclusion criteria 
will be selected and will have an interview with the principal investigator in which they will sign their 
letter of commitment and informed consent, then they will be subjected to the randomization 
process with a 2:1 allocation for treatment and controls, respectively. Subsequently, they will be 
submitted to the two nutritional treatments and will be clinically evaluated every week and will 
receive nutritional, psycho emotional and physical activity counseling. At each visit, adverse effects, 
changes in clinical status will be recorded and the presence of ketone bodies in capillary blood will 
be determined with the Freestyle Abbott optium H β-Ketone (β-hydroxy-Butyric Acid) device; during 
nutritional counseling, MFBIA will be performed using the In-Body 570 body composition analyzer. 
When ketone body levels above 0.8 mmol/liter are detected, a new arterial blood gas analysis will 
be taken; for patients who do not have elevated ketone bodies, an arterial blood gas will be taken 
between the first and second week of treatment. A new biochemical profile determination will be 
performed when patients have lost 40% of their overweight or between 10 and 12 kg, whichever 

occurs first. And new biochemical evaluations when the decrease of Ketone Bodies below 0.4 mmol/l 
is detected or when patients have reached a loss of 60 to 70% of their overweight and one more 
when they reach their weight loss goal. Subsequently, only clinical and nutritional follow-up will be 
given along with psycho-emotional support and physical activity advice every 3 months up to 12 
months and every 6 months up to 24 months. 
7.2 Study design.  
 
Longitudinal, Prospective, Controlled Randomized Clinical Trial.  
 
7.3 Study population.  
 
Patients of either sex, between 18 and 60 years of age, with a body mass index (BMI) between 30 
and 35 kg/m2.  
 
7.4 Sample.  
 
The sample will be obtained by open call through social media and all patients who come with their 
clinical analysis and meet the inclusion criteria will be evaluated until the sample number is reached.  
In order to obtain 95% power in this Controlled Clinical Trial and with a 95% CI, a 3:1 case-control 
ratio is established, considering a 35% attrition rate, 56 cases and 32 controls will be included and 
subsequently crossed to become cases. (Calculated with EPIinfo STATCALC for sample size)  
Two blinded arms are proposed for the physician and the patient.  
 
Obese patients assigned to the low-fat normoprotein controlled ketogenic diet group.  
 
Obese patients assigned to a balanced hypocaloric diet. And who will subsequently be subjected to 
a controlled normoproteic low-fat ketogenic diet. 
 
 

7.5 Inclusion, exclusion and elimination criteria.  
 
7.5.1 Inclusion:   
 
• 
Men and Women  
• 
18 to 60 years of age  
• 
With BMI between 30 and 35 Kg/m2  
• 
Who has not taken weight loss treatment in the last 6 months  
 
7.5.2 Exclusion  
 
• 
Pregnant or breastfeeding patients.  
• 
Patients with severe eating disorders, alcoholism, or drug addiction.  
• 
Patients with severe psychological disorders (e.g. schizophrenia, bipolar disorder).  
• 
Patients with hepatic alteration defined as increase of ALT, AST, GGT more than 4 times the 
reference value.  
• 
Patients with renal impairment defined as a glomerular filtration rate below 60 ml/min.  
• 
Patients with type 1 or insulin-dependent DM, or DM2 on insulin therapy.  
• 
Patients with obesity caused by endocrinological diseases (except type 2 DM).  
• 
Patients with hemopathies.  
• 
Cancer patients.  
• 
Patients with active cardiovascular or cerebrovascular disease (heart rhythm disorders, 
recent infarction [<6m], unstable angina, decompensated heart failure, recent vascular accident 
[<6m]).  
• 
Patients with gout.  
• 
Patients with renal lithiasis.  
• 
Patients with cholelithiasis.  
• 
Patients with depression.  
• 
Patients with electrolyte disorders.  

• 
Patients with orthostatic hypotension.  
• 
Patients with an altered or abnormal electrocardiogram.  
 
7.5.3 Elimination criteria  
 
• 
Patients who drop out and decide to stop participating in the study.  
 
(The patient has the right to withdraw from the study at any time, without the need to offer any 
explanation and without affecting the patient's future care or health care).  
• 
The patient may also be withdrawn from the study at any time at the discretion of the 
investigator or the sponsor, for administrative or behavioral reasons or for missing two consecutive 
follow-up visits.  
• 
Patients who during follow-up present any of the following criteria: Any serious adverse 
event  
• 
Incoercible vomiting and nausea that do not allow following an oral diet.  
• 
Worsening of diabetes control in patients with type II diabetes mellitus or insulin resistance  
• 
Uncontrolled hypertension (SBP > 150 mmHg or SBP < 90 mmHg in successive repetitions).  
• 
The reasons for abandonment of the study must be clearly documented in the registration 
notes. Any adverse reactions will be immediately reported to the Pharmaco-Surveillance system in 
charge of Dr. Francisco J Nachón García Principal Investigator.  
 
 
 
 

7.6  Variables 
Variable name  
Conceptual 
definition  
Operational definition  Type of variable 
and 
measurement 
scale  
Instrument for  
measurement  
Clinical Variables  
Age  
Life span of a person 
from birth to a given 
point in time  
Age expressed by the 
patient 
during 
interrogation  
Quantitative, 
Ratio, years.  
Interrogation 
Registration form. 
Identification 
form section  
Sex  
Anatomical features 
that 
differentiate 
men from women  
Sex expressed by the 
patient 
during 
interrogation  
Qualitative 
Nominal, Male, 
Female  
Interrogation 
Registration form. 
Identification 
form section  
Weight  
Mass 
of 
an 
individual expressed 
in kilograms  
kg measurement with 
clinical scales  
Quantitative, 
Ratio, Unit Kg, 
Minimum 
20 
Maximum 350  
Data 
recording 
form, using In-
Body 
electronic 
scales  
Size  
Distance from the 
floor to the crown of 
the head with the 
body resting on a 
flat surface and 
fully extended. 
Standing 
height 
measurement, without 
shoes, 
with 
a 
calibrated 
stadiometer. 
Quantitative, 
Ratio, Unit cm 
Min. 100, Max. 
270,  
Data 
recording 
form, using a  
 
Blood Pressure  
It represents the 
pressure exerted by 
the force of the 
heartbeat on the 
resistance of the 
arterial walls.  
It 
is 
commonly 
measured 
with 
an 
ESFIGMOMANOMETE
R in the upper arm at 
the brachial artery.  
Quantitative, 
Ratio, 
Unit 
mmHg. 
Min. 
60-80, 
Max. 
120-180  
Data 
recording 
form, 
using 
a 
sphygmomanome
ter.  
Heart Rate  
Number of times the 
ventricles of the heart 
contract per unit of 
time, usually minute.  
Number of beats per 
minute.  
Quantitative, 
Ratio, 
Unit 
l/minute. 
Minimum 
48, 
Maximum 120  
Data registration 
form  
Measurement 
with 
digital 
monitor.  
SaO2  
Determination 
of 
O2 saturation in 
hemoglobin, 
through 
a 
non-
invasive 
oximeter 
using 
pulse 
oximetry.  
Oxygen 
saturation 
percentage  
Quantitative, 
Ratio, 
% 
Saturation, 
Minimum 90%, 
maximum 150%.  
Registration Form  
pulse 
oximetry 
using 
a 
noninvasive 
oximeter.  

Body 
temperature  
Property of bodies 
that determines the 
direction of heat 
flow produced by 
the energy released 
from the motion of 
atomic particles.  
Measuring the heat 
level of a human  
Quantitative, 
Ratio,  
Degrees Celsius  
Minimum 35.5  
Maximum 42.0  
Data Registration 
Form.  
Digital 
thermometer.  
Body Composition Variables  
BMI  
Indicator of body 
density determined 
by the ratio of body 
weight 
to 
body 
height.  
BMI falls into these 
categories: below 18.5 
(underweight); 
18.5-
24.9 (normal); 25.0-
29.9 
(overweight); 
30.0 
and 
above 
(obese).  
Quantitative, 
Ratio,  
BMI = weight 
(kg) 
/ 
height 
squared 
(m2). 
Unit 
Kg/m2, 
Minimum 
11, 
Maximum 75  
Data registration 
form,  
Muscle Mass  
Volume 
of 
total 
body 
tissue 
corresponding 
to 
muscle. , 
From the point of view 
of body composition, it 
corresponds to lean 
mass. 
Quantitative, 
Ratio.  
Unit 
Kg. 
Minimum 10  
Maximum 150 
Data registration 
form 
Multi-
frequency 
Bioelectrical 
Impedance 
Equipment 
Fat Mass  
Percentage 
of 
body weight made 
up 
of 
adipose 
tissue  
Amount of fat in the 
body  
Quantitative, 
proportion, Unit 
Percentage.  
Minimum 9  
Maximum 80  
Data registration 
form  
Multi-frequency 
Bioelectrical 
Impedance 
Equipment  
Visceral Fat  
Fatty tissue within 
the 
abdominal 
cavity, 
which 
includes visceral fat 
and retroperitoneal 
fat.  
It 
is 
the 
most 
metabolically active fat 
in 
the 
body. 
Its 
increase is associated 
with 
metabolic 
complications 
of 
obesity.  
Quantitative, 
Ratio.  
Unit Index.  
From 1 to 40  
Data registration 
form  
Multi-frequency 
Bioelectrical 
Impedance 
Equipment  
Bone Mass  
Measurement 
of 
the 
amount 
of 
minerals 
(usually 
calcium 
and 
phosphorus) 
contained in the 
bones.  
Skeletal weight  
Quantitative, 
Ratio  
Unit Kg.  
From 1 to 7 kg.  
Data registration 
form  
Multi-frequency 
Bioelectrical 
Impedance 
Equipment  
Total 
body 
water  
Amount of liquids, 
mainly water, found 
inside the body.  
Percentage of the body 
that corresponds to 
water  
Quantitative 
Proportion.  
Unit % and/or 
Kg.  
0 a 150  
Data registration 
form  
Multi-frequency 
Bioelectrical 

Impedance 
Equipment  
Waist 
circumference  
Measurement 
established at mid-
armpit, at the point 
between 
the 
bottom of the last 
rib and the highest 
part of the hip.  
Measurement 
made 
with a tape measure 
directly on the skin 
(without clothing). It 
will be measured at 
the 
height 
of 
the 
middle of the armpit, 
at the point between 
the bottom of the last 
rib and the highest 
part of the hip.  
Unit 
Cm 
, 
Minimum 30 , 
Maximum 200  
Registration form. 
Using 
tape 
measure  
Hip 
circumference  
specific 
anthropometric 
measurement 
for 
hip circumference 
measurement 
Circumference of the 
widest part above the 
buttocks. Minimum 30, 
Maximum 200 
Quantitative, 
Ratio  
Unit cm.  
Recording format, 
measuring 
with 
tape measure. 
Muscular 
Strength  
The hand grip force 
measured by  
Isometric 
muscle 
strength 
in 
the 
dominant hand  
Quantitative 
Ratio  
Kg/Strength  
Registration Form  
Digital 
dynamometer.  
Blood Ketones  
The blood ketone 
test measures the 
level of butyrate 
(ketones) 
in 
the 
blood.  
Ketone 
bodies 
are 
substances produced 
by the body when cells 
do not receive enough 
glucose.  
Quantitative, 
Ratio  
Unit mmol/liter  
Minimum 0.01  
Maximum 25  
Registration Form  
Abbott 
Ketone 
Test  
Biochemical and Metabolic Variables  
Hb  
Oxygen 
Transporting 
Protein 
in 
erythrocytes  
Oxygen 
Transporting 
Protein in erythrocytes  
Quantitative 
Ratio.  
Gr/l.  
minimum 10  
maximum 16  
Registration 
format. 
Clinical 
laboratory 
determination  
Hto  
Proportion 
of 
formed elements in 
the blood  
Proportion of formed 
elements in the blood  
Quantitative 
Ratio  
minimum 27  
Maximum 50  
Registration 
format. 
Clinical 
laboratory 
determination  
Leukocytes  
Number of white 
blood cells per unit 
volume in venous 
blood  
Number of white blood 
cells per unit volume in 
venous blood  
Quantitative, 
Ratio.  
Quantity per cc  
Minimum 4,000  
Maximum 
18,000  
Registration 
format. 
Clinical 
laboratory 
determination  

Neutrophils  
Granular nucleated 
leukocytes 
participating 
in 
inflammatory 
processes.  
Number of neutrophilic 
leukocytes  
Quantitative, 
Ratio.  
Quantity per cc  
Minimum 4,000  
Maximum 
18,000  
Registration 
format. 
Clinical 
laboratory 
determination  
Lymphocytes  
White 
blood 
cells 
formed by lymphatic 
tissue.  
Number 
of 
lymphocytes in blood 
cell counts  
Quantitative, 
Ratio.  
Quantity per cc  
Minimum 1,000  
Maximum 8,000  
Registration 
format. 
Clinical 
laboratory 
determination  
Fasting 
Blood 
Glucose  
Glycemia 
or 
Glycemia 
is 
the 
amount of glucose 
or sugar in the blood 
and is one of the 
sources of energy 
for 
our 
body, 
especially for the 
cells. 
Blood sample for blood 
glucose 
with 
eight 
hours fasting time  
Normoglycemia 
in fasting 70 to 
100 
mg/dl. 
Hyperglycemia 
higher than 100 
mg/dl 
in 
fasting. 
Diabetes 
126 
mg/dl 
of 
fasting 
blood 
glucose. 
Registration form.  
Blood tests  
HbA1c  
Measurement 
of 
glucose 
concentration 
in 
blood plasma level.  
Glycosylated 
hemoglobin 
is 
considered: HbA1c ≥ 
6.5% (48 mmol/mol) 
for diagnosis of DM2.  
Categorical, 
Ordinal (%), 6% 
very 
low, 7% 
moderate, 
8% 
high, 9% very 
high, 10% risk.  
Registration form.  
Blood 
tests 
Glycosylated 
hemoglobin  
Insulin  
the amount of this 
hormone insulin in 
the blood.  
Blood 
sample 
for 
insulin 
with 
eight 
hours fasting time  
Hyperinsulinemi
a >6μIUI/ml  
Registration form.  
Blood tests  
Creatinine  
Muscle 
protein 
degradation product  
test that measures the 
level of creatinine in 
the blood  
Quantitative, 
Ratio. mg/dl  
Quantity per cc  
Minimum 0.4  
Maximum 1.3  
Registration form.  
Blood tests  
Urea  
A substance formed 
by the body during 
the metabolism of 
proteins 
and 
nitrogenous 
compounds in the 
liver.  
test 
measures 
the 
amount of urea in the 
blood  
Quantitative, 
Ratio. mg/dl  
Quantity per cc  
Minimum 8  
Maximum 54  
Registration form.  
Blood tests  
BUN  
Amount of nitrogen 
from 
protein 
metabolism in the 
blood.  
Test that measures the 
amount 
of 
urea 
nitrogen in the blood.  
Quantitative, 
Ratio. mg/dl  
Quantity per cc  
Minimum 8  
Registration form.  
Blood tests  

Maximum 54  
Uric Acid  
Uric 
acid 
is 
an 
organic compound 
consisting of carbon, 
nitrogen, 
oxygen 
and hydrogen that is 
formed 
when 
purines are broken 
down 
by 
metabolism.  
A test that measures 
the amount of uric acid 
in the blood.  
Quantitative, 
Ratio. mg/dl  
Quantity per cc  
Minimum 2.4  
Maximum 9.0  
Registration form.  
Blood tests  
Sodium  
Electrolytes 
are 
minerals present in 
blood 
and 
other 
body 
fluids 
that 
carry an electrical 
charge. They affect 
the amount of water 
in the body, the 
acidity of the blood 
(pH), muscle activity 
and other important 
processes.  
Determination of the 
amount of sodium in 
blood  
Quantitative, 
Ratio. mEq/l  
Quantity per cc  
Minimum 135  
Maximum 145  
Registration form.  
Blood analysis  
Chlorine 
Electrolytes 
are 
minerals present in 
blood 
and 
other 
body 
fluids 
that 
carry an electrical 
charge. They affect 
the amount of water 
in the body, the 
acidity of the blood 
(pH), muscle activity 
and other important 
processes.  
 
Determination of the 
amount of chlorine in 
blood 
Quantitative, 
Ratio. mEq/l  
Quantity per cc  
Minimum 90  
Maximum 110 
Registration form.  
Blood análisis 
Potassium 
 
Determination of the 
amount of Potassium 
in blood 
Quantitative, 
Ratio. mEq/l  
Quantity per cc  
Minimum 3.5  
Maximum 5.5 
Registration form.  
Blood análisis 

Calcium  
 
Determination of the 
amount of Calcium in 
the blood 
Quantitative, 
Ratio. mg/dl  
Quantity per cc  
Minimum 8.5  
Maximum 10.5 
Registration form.  
Blood análisis 
Phosphorus 
 
 
 
 
 
 
Determination of the 
amount of phosphorus 
in blood 
Quantitative, 
Ratio. mg/dl  
Quantity per cc  
Minimum 2.5  
Maximum 4.5 
Registration form.  
Blood análisis 
Magnesium 
 
Determination of the 
amount of magnesium 
in blood  
Quantitative, 
Ratio. mg/dl.  
Quantity per cc  
Minimum 1.5  
Maximum 2.5 
Registration form.  
Blood análisis 
Albumin 
Acute phase protein 
synthesized by the 
liver. 
Amount of this protein 
in the clear liquid part 
of the blood. 
Quantitative, 
Ratio. mg/dl.  
Quantity per cc  
Minimum 3.4  
Maximum 5.4  
Registration form.  
Blood analysis  
Direct Bilirubin 
A liquid of an oily 
nature, 
formed 
during 
the 
destruction of red 
blood cells, it is 
secreted by the liver 
whose function is to 
digest fatty foods. 
Portion 
of 
bilirubin 
conjugated 
with 
glucuronic acid, moves 
freely 
in 
the 
bloodstream. 
Quantitative, 
Ratio  
Normal 
value 
less 
than 
0.3 
mg/dl (0 less 
than 
5.1 
mcMol/l) 
Registration form.  
Blood analysis  

Indirect 
Bilirubin 
 
Protein-bound portion 
that requires passage 
through 
the 
hepatocyte. 
Quantitative, 
Ratio unit mg/dl  
Normal 
value 
Minimum 
0.1 
Maximum 0.5 
Registration form.  
Blood analysis  
Total Bilirubin 
 
Sum of Direct B. and 
Indirect B. Indirect 
Quantitative, 
Ratio unit mg/dl  
Normal 
value 
Minimum 
0.1 
Maximum 1.2 
Registration form.  
Blood analysis  
SGPT 
Transaminase 
Aminotransferases, 
a group of enzymes 
that transfer amino 
groups 
from 
one 
metabolite 
to 
another, 
located 
mainly in the liver.  
 
Alanine 
aminotransferase, 
predominantly 
hepatic, is released 
into the bloodstream 
when 
the 
liver 
is 
damaged. 
Quantitative, 
Ratio  
unit IU/l  
Normal 
value 
Minimum 
10 
Maximum 41 
Registration form.  
Blood analysis  
SGOT 
Transaminase 
 
Aspartate 
Amino 
Transferase, 
an 
enzyme found in the 
liver and muscle, is 
released 
into 
the 
bloodstream when the 
liver is damaged. 
Quantitative, 
Ratio  
unit IU/l  
Normal 
value 
Minimum 5  
Maximum 37 
Registration form.  
Blood analysis  
GGTP 
 
Primarily 
hepatic 
enzyme released into 
the circulation when 
there is liver damage 
or biliary tract disease. 
Quantitative, 
Ratio  
unit IU/l  
Normal 
value 
Minimum 11  
Maximum 50 
Registration form.  
Blood analysis  

Serum Iron 
 Essential 
mineral 
for the production of 
hemoglobin, 
necessary 
for 
growth 
and 
development.  
 
Test that measures the 
amount of iron in the 
blood.  
Quantitative 
, 
Ratio  
minimum 
60 
mcg/dl  
Maximum 170 
mcg/  
Registration form.  
Blood analysis  
Total 
Cholesterol  
They are the most 
common type of fats 
in the body, coming 
mainly  
from saturated fats. 
Test 
designed 
to 
measure the amount 
of free and protein-
bound cholesterol in 
the blood.  
Quantitative, 
Ratio  
minimum 
100 
mg/dl  
Maximum 200 
mg/dl  
Registration form.  
Blood analysis  
Triglycerides 
They are the most 
common type of fats 
in the body, coming 
mainly  
from saturated fats.  
 
Test 
designed 
to 
measure the amount 
of triglycerides in the 
blood.  
Quantitative, 
Ratio  
Minimum 100  
Maximum 500 
mg/dl  
Registration form.  
Blood analysis  
C HDL 
Combination of fats 
and 
proteins, 
necessary for the 
transport of lipids 
through 
the 
bloodstream.  
High 
Density 
Lipoproteins  
Quantitative, 
Ratio  
Greater 
than 
40 mg/dl  
 
C LDL 
 
Low 
Density 
Lipoproteins 
Quantitative, 
Ratio  
Less than 100 
mg/dl 
Registration form.  
Blood analysis  

C VLDL 
 
Very 
Low 
Density 
Lipoproteins 
Quantitative, 
Ratio  
Less than 130 
mg/dl 
Registration form.  
Blood analysis  
CPK 
Enzyme that acts 
mainly in muscle 
tissue, 
brain 
and 
heart.  
 
A test that measures 
the 
amount 
of 
creatinine kinase in the 
blood 
is 
used 
to 
diagnose and follow up 
on muscle injury or 
damage.  
Quantitative, 
Ratio  
Muscle 
damage value 
less than 200 
IU/l  
Registration form.  
Blood análisis 
Prot. C Reactive  Circulating 
plasma 
protein 
that 
increases in levels in 
response 
to 
inflammation, 
is 
directly related to IL-
6 elevation.  
Acute phase reactant 
protein released into 
the 
plasma 
as 
a 
consequence 
of 
inflammation.  
Quantitative, 
Ratio  
less than 10 
mg/l  
Registration form.  
Blood análisis 
TSH  
Thyroid profile is the 
set 
of 
determinations 
of 
hormone 
levels 
related to thyroid 
function.  
 
Thyroid 
stimulating 
hormone  
Quantitative, 
Ratio  
0.3 to 3 IU  
Registration form.  
Blood análisis 
T3 
 
Triiodothyronine 
Quantitative, 
Ratio  
0.8 to 2 ng/ml 
Registration form.  
Blood analysi 
T3 L 
 
Non-protein-bound 
triiodothyronine 
Quantitative, 
Ratio  
2.3 to 4.4 pg/ml 
Registration form.  
Blood análisis 
T4 
 
Thyroxine 
Quantitative, 
Ratio  
5.4 to 11.5 ng/dl 
Registration form.  
Blood analysis  

T4 
 
Thyroxine  
Quantitative, 
Ratio  
0.75 
to 
1.85 
ng/dl  
Registration form.  
Blood analysis  
Vitamin D  
Nutritional co-factor 
necessary 
for 
calcium absorption  
cholecalciferol 
is 
measured in blood as 
25-OH Vit D  
Quantitative, 
Ratio  
25 to 90 ng/ml  
Registration form.  
Blood analysis  
Gasometric Variables 
PaO2  
Partial pressure of 
oxygen 
is 
the 
measurement 
of 
dissolved 
oxygen 
particles 
in 
the 
blood expressed in 
mmHg.  
Determine the amount 
of dissolved oxygen in 
plasma.  
Quantitative, 
Ratio  
Unit mmHg  
Minimum 75  
Maximum 100  
Registration form.  
Blood analysis  
HCO3  
Bicarbonate 
ion 
plasma 
concentration  
amount of bicarbonate 
in blood  
Quantitative, 
Ratio  
Unit mEq/l  
Minimum 21  
Maximum 30  
Registration form.  
Blood analysis  
Arterial pH  
Indicates 
the 
amount 
of 
hydrogenions 
contained 
in 
the 
blood.  
Determines the degree 
of acidity or alkalinity 
of the blood.  
Quantitative, 
Ratio  
minimum 7.35  
maximum 7.45  
Registration form.  
Blood analysis  
Lactic Acid  
Substance produced 
by muscle tissue and 
blood cells. Lactic 
acid levels increase 
when oxygen levels 
decrease.  
Acidic substance that 
accumulates 
in 
the 
blood and causes a 
decrease in pH, its 
ionized form is lactate.  
Quantitative, 
Ratio  
4.5 to 19 mg/l or 
0.5 
to 
2.2 
mmol/liter.  
Registration form.  
Blood analysis  
Anion Gap  
Difference between 
anions and cations 
measured 
in 
the 
serum  
Difference 
between 
anions 
and 
cations 
measured in serum  
Quantitative, 
Ratio  
unit mEq/l  
minimum 8  
max. 12  
Registration form.  
Blood analysis  
Excess Base  
the amount of acid 
required to return 
the 
pH 
of 
an 
individual's blood to 
a normal value  
the amount of acid 
required to return the 
pH of an individual's 
blood to a normal 
value  
Quantitative, 
Ratio  
Minimum -2  
maximum + 2  
Registration form.  
Blood analysis  

Satisfaction 
and Adherence  
 
 
 
 
 
Satisfaction 
Survey  
Positive assessment 
of 
the 
different 
dimensions of the 
medical 
care 
received  
Interrogation  
Very Satisfied to Very 
Dissatisfied  
Categorical  
Nominal  
Registration form.  
Adherence 
to 
treatment  
Taking 
medication 
according 
to 
the 
dosage 
of 
the 
prescribed 
schedule; 
and 
persistence, taking 
medication 
over 
time.  
Interrogation  
Complied or did not 
comply 
with 
the 
program.  
Categorical  
Nominal  
Registration form.  
adherence 
to 
treatment  
 
7.7 Data collection. 
All data will be captured and recorded digitally in each of the queries through the Google Forms 
platform to consolidate the information in Google Sheets.  
 
In the consultation, medical history data will be collected in the form of interrogation, weight will 
be determined through electronic scales, height through calibrated stadiometers, All measurements 
will 
be 
performed 
according 
to 
the 
WHO 
Physical 
Measurement 
Guide 
2014 
(www.who.int/surveillance /steps/Part3_Section4) Annex 1. In addition, a capillary determination 
of glucose and ketones will be performed at each clinical consultation. Once patients are drawn by 
lot they will be assigned to one of the control centers distributed in Mexico City, they will always 
have to go to the same control center (VIME). The consultation visits will be weekly for weight 
control and clinical check-up and every two weeks alternately for physical and psychological 
counseling.  
 
Blood samples will be collected in Specialized Clinical Laboratories according to NOM-253-SSA1-
2012 and the laboratory sample collection manual in force in each laboratory. A venous sample will 
be taken to determine Complete Blood Biometry, Blood Chemistry of 27 elements, Basic thyroid 
profile, Glycosylated  
 
 

7.8 Measuring instruments.  
 
With all the data, a database will be built in Excel MS ®. Patient satisfaction will be measured with 
the Likert Scale, which consists of 5 possible answers per item: very satisfied, satisfied, indifferent, 
dissatisfied and very dissatisfied. (attached)  
 
7.9 Statistical analysis. 
 
Descriptive statistical tests will be performed establishing general and group measures, determining 
variability measures such as standard deviation and Confidence Interval, comparative inferential 
tests will be performed within and 25     between groups, for quantitative variables it is proposed as 
an initial T-test, which will be contrasted according to the conditions of normality and 
homoscedasticity of the sample. For qualitative variables, X2 is initially proposed, which will be 
contrasted according to the same conditions; one-way ANOVA and repeated measures ANOVA will 
also be used. Microsoft Excel 365 and SPSS V 21  
 
7.10 Description of treatments  
 
7.10.1 Low-fat normoprotein Controlled Ketogenic Diet.  
 
Patients randomly assigned to this group will undergo a standardized weight loss program under a 
nutritional intervention, physical exercise plan and emotional support.  
 
The nutritional intervention is based on commercial preparations adjusted to 6 different stages.  
Frank ketosis: the initial diet will consist of a very low calorie ketogenic diet (between 650 and 730 
kcal/day) in 5 meal times, based on commercial and vegetable preparations with low glycemic index, 
an average of 1.2 g of protein/kg of ideal weight/day, 20 g/day of lipids based on essential fatty acids 
and less than 60 g/day of absorbable carbohydrates. Patients will also receive vitamin and trace 
element supplements (sodium chloride, magnesium oxide, calcium carbonate) to cover the daily 
requirements recommended for this type of diet. There is no stipulated time for this nutritional 

intervention, the advance to the next stage is proposed as soon as the patient has lost 50% of his or 
her excess weight.  
 
Mixed Ketosis: in this stage, one or two intakes of commercial preparations will be progressively 
replaced by proteins of natural origin (meat, fish, eggs, etc.), which will discreetly increase by 100 
to 150 Kcal/day, without the patient 26.    
 
Leaving the state of ketosis, the supplementation of vitamins and minerals will continue until the 
patient reaches 70% loss of excess weight.  
 
Transition Stage: In this stage simple carbohydrates based on fruit and some complex carbohydrates 
in the form of cereals are added to the previous program, which allows the exit from the state of 
ketosis to enter a controlled hypocaloric diet of approximately 1300 to 1500 kcal/day to 
metabolically readapt to the consumption of macronutrients in an approximate proportion of 30 to 
35% protein, 25% fat and 40 to 45 % carbohydrates. Patients will receive vitamin supplements to 
cover daily needs. Weight loss is not expected at this stage due to its short duration.  
 
Integral and maintenance phase: during this stage the patient will follow a hypocaloric diet adapted 
to his measured energy expenditure, which may vary between 1300 and 2250 kcal/day, with a 
macronutrient distribution of 50% carbohydrates, 25% proteins and 25% fats, according to the 
Diogenes study (17), in this stage the process of dietary reeducation will be completed with a 
regimen in which the loss of 20 or 30% of the remaining excess weight is expected to be completed.  
 
7.10.2 Hypocaloric Balanced Diet  
 
Balanced hypocaloric diet (caloric intake 20% below basal metabolic expenditure measured by 
Multifrequency Bioelectrical Impedance or calculated according to the FAO/WHO/UN formula 
(FAO/WHO/UNU (1985). Energy and Protein requirements. Technical Report Series No 724, World 
Health Organization, Geneva). The usual caloric intake of a balanced hypocaloric diet is between 
1,200 and 1,400 kcal per day with a macronutrient distribution of 50% carbohydrates, 25% proteins 
and 25% fats, according to the Diogenes study (17). 27  
 

8. ETHICAL CONSIDERATIONS  
 
In the present project, the ethical principles for medical research on human beings, established in 
the Declaration of Helsinki of the World Medical Association, in the General Health Law (Official 
Gazette of the Federation, 2015), in the Regulations of the General Health Law on Health Research 
and in the Mexican Official Standard NOM-012-SSA3-2012, will be specifically addressed. The 
research is considered with minimal risk according to the Regulation of the General Health Law on 
Health Research. It will be submitted to the Research Committees of the Institute of Health Sciences, 
and to the Research Ethics Committee. The informed consent process will be carried out by the 
researcher responsible for the project, requesting the patient's authorization for his/her 
participation. In the process of this project it is considered that the benefit will be greater than the 
risk, as well as the confidentiality of the patients will be kept at all times.  
 
8.1. Informed Consent  
 
Prior to inclusion in the study, all investigators must provide the patient with information about the 
study by means of the Patient Information Sheet (Appendix), propose participation in the study, 
answer any questions and ask the patient to fill in the Informed Consent Form (Appendix), which 
will be kept in the patient's own file.  
 
8.2. Evaluation by an Ethics Committee  
 
All materials from this study will be submitted to an accredited Clinical Research Ethics Committee 
(IRB) for evaluation. The study will be initiated once IRB approval has been obtained.  
 
8.3. Confidentiality  
The study data will be entered into an automated file owned by the promoter. The analysis of the 
results of the study will be made from the dissociated database, without personal data, so that no 
subject can be identified or identifiable.  

 
9. Resources  
 
9.1 Material and Financial Resources Zele 
Products  
$2,484,000.00  
Appointments  
$729,000.00  
In.Body  
$510,000.00  
Computer Equipment  
$75,000.00  
Dynamometers  
$2,260.00  
Lab tests  
$572,184.00  
Diagnostic reagents  
$35,000.00  
Other  
$10,000.00  
Total  
$4,417,444.00  
 
 
9.2 Human Resources  
In addition to the researchers, 4 clinical nutritionists, 4 psychologists, 4 physical activity 
advisors, and a group of external auditors from the Instituto Tecnolo gico de Estudios 
Superiores de Monterey will participate in the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
10. Timeline (Gant scheme) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Meses 2021 
Activity 
Jun 
Jul 
Ago 
Sep 
Oct 
Nov 
Dic 
Ene 
Feb 
Mar 
Abr 
Writing and revision 
  
  
  
  
  
  
  
  
  
  
  
Financial approval 
  
  
  
  
  
  
  
  
  
  
  
Research Committee 
  
  
  
  
  
  
  
  
  
  
  
Ethics Committee 
  
  
  
  
  
  
  
  
  
  
  
Staff training 
  
  
  
  
  
  
  
  
  
  
  
Convocatoria - Call for proposals 
  
  
  
  
  
  
  
  
  
  
  
Participant recruitment 
  
  
  
  
  
  
  
  
  
  
  
Protocol 
  
  
  
  
  
  
  
  
  
  
  
Partial data capture and analysis 
  
  
  
  
  
  
  
  
  
  
  
Follow-up analysis 
  
  
  
  
  
  
  
  
  
  
  
Initial results 
  
  
  
  
  
  
  
  
  
  
  
Writing the first paper 
  
  
  
  
  
  
  
  
  
  
  
Publication of initial results 
  
  
  
  
  
  
  
  
  
  
  

11. Bibliography.  
 
1. Organizacio n 
Mundial 
de 
la 
Salud. 
Obesidad 
y 
Sobrepeso. 
Disponible: 
https://www.who.int/es/news-room/fact-sheets/detail/obesity-and-overweight. 
U ltimo acceso: 20 enero 20201.  
2. Regional Overview of Food Insecurity Latin America and the Caribbean. 2015. 
http://www.fao.org/3/a-i4636e.pdf  
3. D.R. Secretarí a de Salud. Me xico Gobierno de la Repu blica. Estrategia Nacional para la 
Prevencio n y el Control del Sobrepeso, la Obesidad y la Diabetes 2018  
4. Cano-Rodrí guez I et al. Dietas bajas en hidratos de carbono frente a dietas bajas en 
grasas. Endocrinol Nutr 2006;53:209-17  
5. WHO. 
Obesidad 
y 
sobrepeso. 
Nota 
descriptiva 
N°311. 
Enero 
2015. 
http://www.who.int/mediacentre/factsheets/fs311/es/  
6. Seis estrategias para la perdida de peso. Jun 19, 2020. https://www.mayoclinic.org/es-
es/healthy-lifestyle/weight-loss/in-depth/weight-loss/art-20047752.  
7. Pirozzo S, et al. Should we recommend low-fat diets for obesity? Obes Rev 2003; 4: 83-
90.  
8. Lindner PG and Blackburn GL. Multidisciplinary approach to obesity utilizing fasting 
modified by protein-sparing therapy. Obesity/Bariatric Med. 1976; 5:6 //Blackburn GL, 
Greenberg I. Multidisciplinary approach to adult obesity therapy. Int J Obes. 
1978;2(2):133-42.  
9. Dessanzo V et al. Morbid Obesity. An integral, intensive and ambulatory approach. 
Results after 3 years in the treatment of extreme obesity. Int J Obes. 2002; 26, S101:381.  
10. Tschochner et al. Body weight and life-style modification after a weight reduction 
program. Int J Obes. 2002; 26, S101:384  
11. Elfhag K, Ro ssner S. Initial weight loss is the best predictor for success in obesity 
treatment and sociodemographic liabilities increase risk for drop-out. Patient Educ 
Couns. 2010 Jun;79(3):361-6.  
12. Handjieva-Darlenska T, Handjiev S, Larsen TM, van Baak MA, Jebb S, Papadaki A et al. 
Initial weight loss on an 800-kcal diet as a predictor of weight loss success after 8 
weeks: the Diogenes study. Eur J Clin Nutr. 2010 Sep;64(9):994-9.  
13. Handjieva-Darlenska T1, Holst C, Grau K, Blaak E, Martinez JA, Oppert JM et al. Clinical 
correlates of weight loss and attrition during a 10-week dietary intervention study: 
results from the NUGENOB project. Obes Facts. 2012;5(6):928-36.  
14. Nackers LM1, Ross KM, Perri MG. The association between rate of initial weight loss and 
long-term success in obesity treatment: does slow and steady win the race? Int J Behav 
Med. 2010 Sep;17(3):161-7.  
15. Blackburn GL. Weight of the nation: moving forward, reversing the trend using medical 
care. Am J Clin Nutr. 2012 Nov;96(5):949-50.  
16. Hemmingsson E1, Johansson K, Eriksson J, Sundstro m J, Neovius M, Marcus C. Weight 
loss and dropout during a commercial weight-loss program including a very-low-
calorie diet, a low-calorie diet, or restricted normal food: observational cohort study. 
Am J Clin Nutr. 2012 Nov;96(5):953-61.  
17. Larsen TM1, Dalskov SM, van Baak M, Jebb SA, Papadaki A, Pfeiffer AF et al. Diets with 
high or low protein content and glycemic index for weight-loss maintenance. N Engl J 
Med. 2010 Nov 25;363(22):2102-13