Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06769035

Active, not recruitingNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionOxidative Stress, Inflammation Biomarkers, Obesity and Overweight

Full registry criteria

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.

Treatments and study arms

Cocoa, amaranth seed and ginger

Dietary Supplement

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

Amaranth seed

Dietary Supplement

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

Cocoa

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

Change from baseline in Insulin Resistance (IR) at 3 monthsChange from baseline visit to final 3 months

Average baseline and final HOMA-IR index

Change from baseline in oxidative stress markers Superoxide Dismutase (SOD), Catalase (CAT) and Glutathione Peroxidase (GPX)Change from baseline visit to final 3 months

Basal and final average of SOD, CAT and GPX

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Universidad de Guadalajara🇲🇽 Guadalajara, Jalisco, Mexico

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