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

About this trial

Last updated a year ago

Study ID

00082

Status

Active not recruiting

Type

Interventional

Phase

N/A

Placebo

Yes

Accepting

18 to 60 Years

All Sexes

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

1. Signed informed consent;

2. Men or women;

3. Age between 18 and 60 years;

4. Waist circumference ≥ 88 cm in women or ≥ 94 cm in men;

5. 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.

Exclusion Criteria

1. On pharmacological treatment or diet for weight control;

2. Routine use of antioxidants in the last 3 months;

3. BMI ≥ 30 kg/m2 or recent bariatric surgery (< 6 months);

4. LDL cholesterol > 160 mg/dL or total cholesterol > 200 mg/dL, and no treatment for dyslipidemia;

5. Major micro or macrovascular complications due to severe metabolic disease (history of acute coronary syndrome, cerebrovascular disease, peripheral arterial insufficiency or aortic aneurysm);

6. Pregnancy or breastfeeding;

7. Refusal to use an effective contraceptive method for the duration of the study;

8. Hypersensitivity to any of the components of the formula or phenylketonurics;

9. Endocrinological or rheumatic diseases;

10. Patient with recent initiation of vigorous physical exercise or exercise routine for weight loss and/or;

11. Liver or kidney failure by clinical and/or laboratory criteria.