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

NCT06769035 | Active Not Recruiting

• 1 other identifier: 00082
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Food supplement; Cocoa; Amaranth seed; Ginger; Oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Insulin Resistance (IR) at 3 months

  Average baseline and final HOMA-IR index

  Change from baseline visit to final 3 months

• Change from baseline in oxidative stress markers Superoxide Dismutase (SOD), Catalase (CAT) and Glutathione Peroxidase (GPX)

  Basal and final average of SOD, CAT and GPX

  Change from baseline visit to final 3 months

Secondary Outcomes (4)

• Change in metabolic variables (Weight, kg) (Height, m) (Body Mass Index BMI)

  Change from baseline visit to final 3-month period

• Change in metabolic variables (Waist Circumference WC, cm)

  Change from baseline visit to final 3-month period

• Change in metabolic variables (% fat, % visceral fat)

  Change from baseline visit to final 3-month period

• Change in metabolic variables (Muscle Mass MM, kg)

  Change from baseline visit to final 3-month period

Other Outcomes (1)

• Treatment-related adverse events

  Change from baseline visit to final 3 months

Study Arms (4)

Food supplement: cocoa, amaranth seed and ginger

ACTIVE COMPARATOR

Group A: 20g Cocoa, 10g amaranth seed and 1g ginger once a day for 12 weeks

Dietary Supplement: Cocoa, amaranth seed and ginger

Food supplement: cocoa

ACTIVE COMPARATOR

Group B: 20g Cocoa once a day for 12 weeks

Dietary Supplement: Cocoa

Food supplement: amaranth

ACTIVE COMPARATOR

Group C: 10g Amaranth seed once a day for 12 weeks

Dietary Supplement: Amaranth seed

Food supplement: placebo

PLACEBO COMPARATOR

Group D: Coloring and flavoring, one dose per day for 12 weeks

Dietary Supplement: Placebo

Interventions

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

Also known as: cocoa, ginger, amaranth seed

Food supplement: cocoa, amaranth seed and ginger

Amaranth seed DIETARY_SUPPLEMENT

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

Food supplement: amaranth

Cocoa DIETARY_SUPPLEMENT

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

Food supplement: cocoa

Placebo DIETARY_SUPPLEMENT

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

Food supplement: placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• On pharmacological treatment or diet for weight control;
• Routine use of antioxidants in the last 3 months;
• BMI ≥ 30 kg/m2 or recent bariatric surgery (\< 6 months);
• LDL cholesterol \> 160 mg/dL or total cholesterol \> 200 mg/dL, and no treatment for dyslipidemia;
• Major micro or macrovascular complications due to severe metabolic disease (history of acute coronary syndrome, cerebrovascular disease, peripheral arterial insufficiency or aortic aneurysm);
• Pregnancy or breastfeeding;
• Refusal to use an effective contraceptive method for the duration of the study;
• Hypersensitivity to any of the components of the formula or phenylketonurics;
• Endocrinological or rheumatic diseases;
• Patient with recent initiation of vigorous physical exercise or exercise routine for weight loss and/or;
• Liver or kidney failure by clinical and/or laboratory criteria.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Location

MeSH Terms

Conditions

Obesity; Overweight; Inflammation

Interventions

Chocolate; ginger extract

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in pharmacology and internist. Professor at University of Guadalajara

Model Details: 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

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 10, 2025
• Study Start: August 20, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)