Clinical trial NCT03608176: Evaluation of the Plant-based Approaches to Stop Obesity Diet for the Treatment of Overweight and Obesity
Official title: Evaluation of the Efficacy of Plant-based Approaches to Stop Obesity Diet in Comparison With a Control Group on Body Weight in Mexican Adults With Overweight and Obesity: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Keywords: Obesity
Randomized Controlled Trial
Lifestyle Intervention
Plants
Water
Weight loss
Diet
Overweight
Lead sponsor: Universidad de Sonora
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The accumulation of excess of body weight is one of the most important problems worldwide, thus effective and accessible treatments are required. Some authors highlighted that treatment is focused solely on lifestyle (diet, physical activity, behavioral therapy) has a limited effect on body weight because it does not consider the biological mechanisms linked to weight loss in patients with obesity. On the other hand, drugs and bariatric surgery consider these biological approaches; however, its costs, safety and effectiveness limits its use on a large scale. Research studies support the existence of compounds in plants (such as epigallocatechin gallate, caffeine, cinnamaldehyde, fiber), and water with biological properties that would contribute to the treatment of overweight and obesity. However, at the moment, these compounds have only been evaluated individually and their effects have been significant but limited clinically, therefore, more research studies are needed to evaluate whether several of these compounds contained in common plants synergistically have a clinical impact on the management of overweight and obesity. The present work integrates diverse plant-based approaches to stop obesity and it is compared with a control group and a waiting list group. The main aim is to evaluate the efficacy of the Plant-based Approaches to Stop Obesity diet (PASO diet) compared with a control group on body weight at 3 months in Mexican adults with overweight and obesity. This is a pilot study designed as a randomized controlled trial. The study will be conducted with a (n=36). The primary outcome is the change in body weight from baseline to 3 months. Secondary outcomes will be the changes from baseline to 3 months in body mass index, waist circumference, systolic and diastolic blood pressure, symptoms of depression, quality of life scales and biochemical parameters (fasting glucose, total cholesterol, LDL cholesterol, HDL-cholesterol, triglycerides and gamma glutamyl transferase). Additionally two 24-hour dietary recall will be measured at baseline and 3 months to evaluate adherence to the intervention.


Eligibility criteria: Inclusion Criteria:

* Mexican adults (\> 20 years and \<55)
* Residents of the city of Hermosillo, Sonora
* Obesity (BMI\> 25 and \<45)
* Availability of time to participate in the study.
* Economic capacity to acquire the assigned diet
* Grant informed consent
* Keep a dietary record for one week prior to the intervention

Exclusion Criteria:

* Medical conditions that constitute a contraindication for the intervention, such as de-controlled diabetes, dyslipidemia with pharmacological treatment, blood pressure ≥160 / 100 mmHg, heart failure, renal failure, etc.
* Previous bariatric surgery
* Participate in another intervention or treatment for the management of obesity
* Use of drugs or substances with an effect on weight, for example, metformin, orlistat or corticoids
* Weight loss\> 5% of total body weight in the last 4 months
* Pregnancy or lactation
* Another member of the family or acquaintance who has agreed to participate in the study
* Consumption of more than 10 alcoholic drinks per week
* Use of addictive substances as drugs of abuse
* Psychiatric condition that prevents adherence to treatment, such as severe depression, bipolarity and schizophrenia Illiteracy
* Gastrointestinal problems or any condition where coffee, tea or cinnamon are not well tolerated or contraindicated
* People who drink more than 4 cups of coffee (tea) per day or its equivalent in caffeinated beverages.

Primary outcomes:
measure: Change in body weight
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Change in waist circumference
timeFrame: baseline to 3 months
measure: Change in body fat percentage
timeFrame: baseline to 3 months
measure: Change in the Beck Depression Inventory score
timeFrame: baseline to 3 months
measure: Change in the Short Form-36 Health Survey score
timeFrame: baseline to 3 months
measure: Change in systolic and diastolic blood pressure
timeFrame: baseline to 3 months
measure: Change in fasting glucose
timeFrame: baseline to 3 months
measure: Change in total cholesterol
timeFrame: baseline to 3 months
measure: Change in LDL-cholesterol
timeFrame: baseline to 3 months
measure: Change in HDL-cholesterol
timeFrame: baseline to 3 months
measure: Change in triglycerides
timeFrame: baseline to 3 months
measure: Change in gamma glutamyl transferase
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Centro de Promoción de Salud Nutricional (CPSN)
state: Sonora
Study officials:
affiliation: Universidad de Sonora
name: Rolando G Díaz Zavala, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: