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Clinical Trial Summary

Obesity 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 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 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 4 months in Mexican adults with obesity. The study design is a randomized controlled trial. A pilot study will be conducted prior to the main study with a (n=36). The primary outcome is the change in body weight from baseline to 4 months. Secondary outcomes will be the changes from baseline to 4 months in body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life scales and biochemical parameters (fasting glucose, total cholesterol, LDL cholesterol, HDL-cholesterol, triglycerides and gamma glutamyl transferase). The previous measurements will apply both in the pilot study and in the study except for the biochemical parameters that will only be included in the main study. 24-hour dietary recall will be measured at baseline and 4 months to evaluate adherence to the intervention. Sample size calculation of the main study will be estimated based on data from the pilot study considering an alpha error of 0.05 and power of 80%.

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 Not yet recruiting
Phase N/A
Start date August 1, 2018
Completion date August 1, 2019

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