Clinical Trial

Effect of a Food Supplement with Natural Extracts of Cocoa, Amaranth Seed and Ginger in Overweight or Obese Patients

Active, Not Recruiting
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Record status
This record was last updated January 10, 2025 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
Summary
Clinical trial, randomized, double-blind, controlled with a placebo group, 40 patients between 18 and 60 years of age, with the presence of overweight, will be divided into parallel groups, group A cocoa, amaranth seed and ginger, group B cocoa, group C amaranth, group D placebo, with the objective of evaluating the effect of the nutritional supplement in overweight or obese patients on cytokines, insulin resistance and oxidative stress. The study consists of 4 visits: screening (-21 days), baseline (day 0), follow-up (week 6) and end of the study (12 weeks) and 2 follow-up calls (weeks 3 and 10). For 12 weeks they will take one sachet of the supplement containing cocoa, amaranth seed and ginger or placebo daily. Waist circumference, somatometric parameters, vital signs, nocturnal decrease in blood pressure, ankle arm index, cytokines, glucose, glycated hemoglobin, hs-CRP, lipid profile, insulin, antioxidant effect, blood cytometry, function tests will be evaluated. liver, urea, creatinine, uric acid and urine pregnancy test for women of childbearing age. A 24-hour reminder and frequency of consumption will be carried out to assess the diet at each of the visits and nutritional recommendations will be given. Adherence to treatment (Morisky-Green), adverse events and concomitant treatments will be verified throughout the study.
Trial Details
NCT Number NCT06769035
Lead Sponsor University of Guadalajara
Conditions Oxidative Stress, Inflammation Biomarkers, Obesity and Overweight
Enrollment 40 participants
Start Date 2023-08-20
Primary Completion 2025-06 (estimated)
Study Completion 2025-06 (estimated)
Updated on ClinicalTrials.gov 2025-01-10