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

NCT06769035 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-10

No results posted yet for this study

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.

Conditions

  • Oxidative Stress
  • Inflammation Biomarkers
  • Obesity and Overweight

Interventions

DIETARY_SUPPLEMENT

Cocoa, amaranth seed and ginger

Sachet with 20gr of cocoa, 10g of amaranth seed and 1g of ginger, one dose per day for 12 weeks

DIETARY_SUPPLEMENT

Amaranth seed

Sachet with 10g of amaranth seed one dose per day for 12 weeks

DIETARY_SUPPLEMENT

Cocoa

Sachet with 20gr of cocoa one dose per day for 12 weeks

DIETARY_SUPPLEMENT

Placebo

Sachet with coloring and flavoring, one dose per day for 12 weeks one dose per day for 12 weeks

Sponsors & Collaborators

  • University of Guadalajara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-20
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06769035 on ClinicalTrials.gov