Evaluation of the Plant-based Approaches to Stop Obesity Diet for the Treatment of Overweight and Obesity

NCT03608176 | Unknown

• 1 other identifier: PASOdiet-OBMEX-2018
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Obesity; Randomized Controlled Trial; Lifestyle Intervention; Plants; Water; Weight loss; Diet; Overweight

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  baseline to 3 months

Secondary Outcomes (11)

• Change in waist circumference

  baseline to 3 months

• Change in body fat percentage

  baseline to 3 months

• Change in the Beck Depression Inventory score

  baseline to 3 months

• Change in the Short Form-36 Health Survey score

  baseline to 3 months

• Change in systolic and diastolic blood pressure

  baseline to 3 months

Study Arms (3)

PASO diet group

EXPERIMENTAL

Other: PASO diet group

Low-fat diet group

ACTIVE COMPARATOR

Other: Low-fat diet group

Waiting list group

OTHER

Other: Waiting list group

Interventions

PASO diet group OTHER

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).

PASO diet group

Low-fat diet group OTHER

This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol.

Low-fat diet group

Waiting list group OTHER

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.

Waiting list group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Sonora: lead

Study Sites (1)

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, 83000, Mexico

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Rolando G Díaz Zavala, Ph.D.

  Universidad de Sonora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rolando G Díaz Zavala, Ph.D.

CONTACT

6622893793; giovanni.diaz@unison.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: July 31, 2018
• Study Start: October 10, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

ME (1)