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Clinical Trial 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT03608176
Study type Interventional
Source Universidad de Sonora
Contact Rolando G Díaz Zavala, Ph.D.
Phone 6622893793
Status Recruiting
Phase N/A
Start date October 10, 2018
Completion date August 1, 2019

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