NCT03608176

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Universidad de Sonora · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).
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	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.

Timeline

• Start date: 2018-10-10
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2018-07-31
• Last updated: 2020-04-15

Locations

1 site across 1 country: Mexico