NCT06769035Active, not recruiting
Effect of a Food Supplement with Natural Extracts of Cocoa, Amaranth Seed and Ginger in Overweight or Obese Patients
Effect of a Food Supplement with Extracts of Cocoa, Amaranth Seed and Ginger in Overweight or Obese Patients in the Outpatient Clinic of the New Juan I. Menchaca Civil Hospital
Source: ClinicalTrials.gov · Last updated 10 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 13 Dec 2024
- Start date
- 20 Aug 2023
- Primary completion date
- Jun 2025
- Lead sponsor
- University of Guadalajara
- Diseases
- Obesity
- NCT number
- NCT06769035
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 20 Aug 2023 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- BMI ≥ 30 kg/m2 or recent bariatric surgery (\< 6 months);
Other illness
- Major micro or macrovascular complications due to severe metabolic disease (history of acute coronary syndrome, cerebrovascular disease, peripheral arterial insufficiency or aortic aneurysm);
- Hypersensitivity to any of the components of the formula or phenylketonurics;
- Endocrinological or rheumatic diseases;
Lab values
- LDL cholesterol \> 160 mg/dL or total cholesterol \> 200 mg/dL, and no treatment for dyslipidemia;
- Liver or kidney failure by clinical and/or laboratory criteria.
Other
- On pharmacological treatment or diet for weight control;
- Routine use of antioxidants in the last 3 months;
- Pregnancy or breastfeeding;
- Refusal to use an effective contraceptive method for the duration of the study;
- Patient with recent initiation of vigorous physical exercise or exercise routine for weight loss and/or;
Who the study is looking for
- Signed informed consent;
- Men or women;
- Age between 18 and 60 years;
- Waist circumference ≥ 88 cm in women or ≥ 94 cm in men;
- Plus one of the following criteria:
- BMI \>25 kg/m2 and not \> 30 kg/m2 in both genders or history of bariatric surgery \> 6 months;
- Fasting serum glucose of 100-125 mg/dL or HbA1c of 5.7-6.4% or on pharmacological treatment with OAD for prediabetes;
- Insulin resistance by HOMA \> 2.6 and insulin sensitivity by QUICKI \<0.34;F.
- Negative pregnancy test.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de Guadalajara Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.