Clinical trial NCT04646733: Effect of a Low-carbohydrate, High-protein Energy-restricted Diet on Weight and Body Composition Using DXA
Official title: Effect of a Low-carbohydrate, High-protein Ketogenic Diet on Weight and Body Composition: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Body Composition
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled clinical study. Subjects are assigned to one of two groups: the intervention group (group A or high protein diet or HPD) and the group without high protein diet or NHPD. The assignment is done with the use of MedCalc software and the option to create random groups. Both groups are treated equally except for the procedure or diet. The blind or double-blind procedure is not used in this study. Both groups are treated during the same study period. The maximum number of patients to be evaluated per day will be three. Patients are not mixed from one group or another in each evaluation.
Primary purpose: TREATMENT

Brief summary: People often choose certain diets to lose weight or to change their habits or lifestyle. The Dukan diet was created in the '70s and took on importance in the last decade. It is a 4 phase diet similar to the Atkins diet. However, this diet is aggressive in its first phase because it suppresses carbohydrates, the main source of external energy being saturated low-fat protein. Studies of this diet are scarce and have been limited to describing the contribution of micronutrients. In nutritional practice, it is often assumed that a popular high-protein or low-calorie ketogenic diet could cause rapid or unfavourable changes in a patient's weight and body composition. However, the effect of these diets in the short or long term on weight and on body fat, muscle mass and other components is not clear. This means that body composition has not been the main objective when analyzing the effect of a popular diet. For this reason, the meta-analyzes focus on weight change and the absence of body composition data is a limitation of the selected studies. Changes in body composition due to a popular diet should be evaluated with techniques such as DXA. The aim of this study is to analyze the effect of a low-carbohydrate, high-protein diet with energy restriction on weight and body composition using DXA. For this, a randomized controlled study will be used where a group will receive the diet protocol. The control group will have a normal diet, and only one oatmeal drink will be added (55 g of oats in 250 ml of water). The drink will contain 1.6 g of BetaG per serving according to FDA recommendations that correspond to the 50% BetaG required per day.

Detailed description: The patients (n = 60) are invited through posters and social networks to recruit a group of 40 overweight subjects (20% above their ideal weight). The protocol is explained in detail to each one, and the patient and two witnesses sign the informed consent. Subjects are assigned to one of two groups: group A: high protein diet (HPD) and group B: non-high protein diet (NHPD). The NHPD is designed according to Mexican nutrition guidelines according to sex and age.

The main anthropometric and biochemical measurements and diet monitoring are performed in the body composition laboratory of the Faculty of Sports Organization (FOD). Four technicians (nutritionists) are in charge of taking the measurements and recording the data. The principal investigators review the quality of the information and the correct completion of the records. Each file will be assigned an identification number. Other nutritionists (graduate students) will be in charge of auditing the information according to the protocol guidelines. Principal Investigators will resolve any discrepancies between technicians and graduate students to ensure data recording, deletion, or reevaluation.

Each patient is asked for a prior medical examination before entering the study. The data from the external medical practitioner are compared with those provided by the patient for the present study.

The main anthropometric variables are measured with the international ISAK methodology. The DXA equipment is calibrated daily, and the result is analyzed and analyzed by a researcher who evaluates whether the measurement is reliable.

The data is recorded in printed formats that are immediately scanned to maintain readability. Later, they are recorded in an Excel sheet with the patient's identification number. In each measurement session, the database is analyzed for abnormal, extreme or unlikely data. Two independent researchers are responsible for reviewing the database every day.

Each patient is cared for by a nutrition student who accompanies him in the basic needs, clothing and transfers to the measurement equipment. At the end of the evaluation, patients receive a complimentary meal and free transportation home.

Patients are monitored through WhatsApp to verify the presence of adverse events with the diet. Also, for any questions with the procedures. All procedures are recorded in paper and electronic form. In addition, they are given an additional number in case of medical emergency or consultation with a nutritionist.

The sample size will be limited in the first stage to 30 patients. Measurements and preliminary analysis will be obtained at 0, day four and day fifteen. The last two measurements will be taken on day 42 and until the subjects reach their ideal body weight.

In the case of missing data or defective quality record, subjects will be removed.

Regarding the statistical analysis, multiple linear regression will be used, where the groups and measurements will be compared on the different measurement days. As covariates, covariates will be incorporated as initial values, age, sex, BMI, among others, will be adjusted. Descriptive statistics will be added.

Eligibility criteria: Inclusion Criteria:

* individuals between the ages of 20 and 30
* who were not currently consuming any drugs or were on diet or exercise treatment.
* patients must have 120% or more of the ideal weight until a BMI of 35.

Exclusion Criteria:

* with no cardiovascular disease, kidney, intestinal or liver disease.
* cholesterol (≥ 200 mg/dL)
* high triglycerides (≥ 150mg/dL)
* glucose (≥ 126mg /dL)

Primary outcomes:
measure: Body fat
timeFrame: Baseline to three months.
measure: Lean mass
timeFrame: Baseline to three months
measure: Weight lost
timeFrame: Baseline to three months
Secondary outcomes:
measure: Body water
timeFrame: Baseline to three months
measure: Resting energy expenditure
timeFrame: Baseline to three months
measure: Caloric and macronutrient intake
timeFrame: Baseline to three months
measure: Serum fasting triglycerides
timeFrame: Baseline to three months
measure: Serum fasting glucose
timeFrame: Baseline to three months
measure: Serum fasting total cholesterol
timeFrame: Baseline to three months
measure: Serum fasting HDL cholesterol
timeFrame: Baseline to three months
measure: Serum fasting albumin
timeFrame: Baseline to three months
measure: Serum fasting total protein
timeFrame: Baseline to three months
measure: Serum fasting total hemoglobin
timeFrame: Baseline to three months
measure: hand strenght with a dynamometer
timeFrame: Baseline to three months
measure: triceps skinfold with a plicometer
timeFrame: Baseline to three months
measure: waist perimeter
timeFrame: Baseline to three months
measure: mid-arm perimeter
timeFrame: Baseline to three months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Facultad de Organización Deportiva, FOD, Universidad Autónoma de Nuevo León
state: N.l.
Study officials:
References:
citation: Anton SD, Hida A, Heekin K, Sowalsky K, Karabetian C, Mutchie H, Leeuwenburgh C, Manini TM, Barnett TE. Effects of Popular Diets without Specific Calorie Targets on Weight Loss Outcomes: Systematic Review of Findings from Clinical Trials. Nutrients. 2017 Jul 31;9(8):822. doi: 10.3390/nu9080822.
citation: Atallah R, Filion KB, Wakil SM, Genest J, Joseph L, Poirier P, Rinfret S, Schiffrin EL, Eisenberg MJ. Long-term effects of 4 popular diets on weight loss and cardiovascular risk factors: a systematic review of randomized controlled trials. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):815-27. doi: 10.1161/CIRCOUTCOMES.113.000723. Epub 2014 Nov 11.
citation: Seid H, Rosenbaum M. Low Carbohydrate and Low-Fat Diets: What We Don't Know and Why we Should Know It. Nutrients. 2019 Nov 12;11(11):2749. doi: 10.3390/nu11112749.