Evaluation of the Plant-based Approaches to Stop Obesity Diet for the Treatment of Overweight and Obesity (PASO diet)

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

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.

Study Overview

• Status: Unknown
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: PASO diet group; Other: Low-fat diet group; Other: Waiting list group

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Sonora
    • Hermosillo, Sonora, Mexico, 83000
      • Recruiting
      • Centro de Promoción de Salud Nutricional (CPSN)
      • Contact: Rolando Giovanni Díaz Zavala, Ph.D.; Phone Number: 4632 6622893793; Email: giovanni.diaz@unison.mx
      • Principal Investigator: Rolando Giovanni Díaz Zavala, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PASO diet group	Other: PASO diet group; This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol. They will also be instructed to consume green tea (2 cups/day for 3 days/week), black tea (2 cups/day for 2 days/week), coffee (2 cups/day for 2 days/week), cinnamon (1 tsp/day for at least 3 days/week), psyllium fiber (3 tsp/day/week) and water (1.5 L/day/week).
Active Comparator: Low-fat diet group	Other: Low-fat diet group; This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol.
Other: Waiting list group	Other: Waiting list group; This group will only receive written information with recommendations on healthy eating. When the study finished, this group will receive a behavioral change protocol with a low-fat, low calorie diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in body weight	baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting glucose		baseline to 3 months
Change in total cholesterol		baseline to 3 months
Change in LDL-cholesterol		baseline to 3 months
Change in HDL-cholesterol		baseline to 3 months
Change in triglycerides		baseline to 3 months
Change in gamma glutamyl transferase		baseline to 3 months
Change in waist circumference		baseline to 3 months
Change in body fat percentage		baseline to 3 months
Change in the Beck Depression Inventory score	The Beck Depression Inventory (BDI) is a 21-item questionnaire that assesses mood over the previous week. Total scores range from 0 to 63, with higher values indicating greater symptoms of depression. Scores of 0-9 reflect minimal (subclinical) symptoms, values of 10-18, 19-29, and ≥30 indicate mild, moderate, and severe symptoms of depression, respectively.	baseline to 3 months
Change in the Short Form-36 Health Survey score	The SF-36 Health Survey evaluates aspects of the quality of life in adult populations (over 16 years of age). The result of its application is the generation of eight concepts or scales of health, result of the average of the sum of the questions contained in the questionnaire for each concept. These concepts are: physical function, physical role, corporal pain, general health, vitality, social function, emotional role and mental health. The SF-36 is a self-applied instrument and contains 36 questions. For each scale, the answers to each question are coded and recoded (10 questions), and the results are interpreted on a scale of 0 to 100, lower results indicate poorer health and greater result better health).	baseline to 3 months
Change in systolic and diastolic blood pressure		baseline to 3 months

Collaborators and Investigators

• Sponsor: Universidad de Sonora
• Investigators: Principal Investigator: Rolando G Díaz Zavala, Ph.D., Universidad de Sonora

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Weight loss; Randomized Controlled Trial; Diet; Lifestyle Intervention; Water; Plants
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: PASOdiet-OBMEX-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No