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

Not Applicable

Active, not recruiting

• Conditions: Oxidative Stress; Inflammation Biomarkers; Obesity and Overweight

• Registration Number: NCT06769035
• Lead Sponsor: University of Guadalajara

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.

Detailed Description

Overweight and obesity are a public health problem with worldwide prevalence and play an important role in the emergence of chronic diseases. Overweight is characterized by low-grade chronic inflammation and is associated with an abnormal inflammatory response, oxidative stress and low sensitivity. to insulin. Inflammation of adipose tissue is initiated and sustained over time by dysfunctional adipocytes that secrete inflammatory adipokines; elevated proinflammatory stimuli directly affect insulin signaling in target tissues. Oxidative stress alters mitochondrial activity, modifies the concentration of inflammation levels associated with many adipocytes, promotes lipogenesis, stimulates the change of preadipocytes for mature adipocytes and regulates the energy balance in neurons that control appetite. It is also an important regulator. of insulin sensitivity.

The solution to the consequences of obesity and overweight, low-grade inflammation, oxidative stress and insulin sensitivity are based on pharmaceutical treatments and surgical processes, but changes in lifestyle are the cornerstone of treatment, however the patient's adherence to treatment is low and the results are long-term, for this reason some authors have dedicated themselves to looking for alternatives that complement changes in lifestyle and improve health status.

Polyphenols are bioactive compounds that have been shown to influence insulin resistance, oxidative stress and inflammation. There is extensive evidence from clinical studies and meta-analyses in overweight patients to support the effects of this study's supplement on waist circumference, weight, BMI, blood pressure, insulin sensitivity, markers of inflammation, and oxidative stress.

Cocoa has been positioned as a preventive phytopharmaceutical due to its polyphenolic compounds, mainly flavonols with anti-inflammatory and antioxidant effects, which can help prevent or delay the complications of DM2 by modulating insulin secretion.

Amaranth seed is a source of protein, calcium, iron, dietary fiber, vitamin E and D, with a high content of monounsaturated fats and polyunsaturated fatty acids such as squalene, which have been given anti-inflammatory and antioxidant properties, Mozak and collaborators in 2018 did a clinical trial with amaranth seed in overweight patients with favorable results in reducing fasting insulin and the HOMA-IR index.

Ginger has been widely studied due to its potential in reducing glucose, lipid and body fat levels, and has been used as a preventative in chronic diseases. A clinical trial conducted in 2019 by Rahimlou and collaborators included 37 participants with metabolic syndrome, significantly decreased fasting glucose levels and improved insulin resistance.

The objective of the present study is to evaluate the effect of a supplement with cocoa, amaranth seed and ginger in overweight patients on inflammation, insulin resistance and oxidative stress.

Study Timeline

• Study Start: 2023-08-20
• Study First Submitted: 2024-12-13
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in Insulin Resistance (IR) at 3 months	Change 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

Secondary Outcome Measures

Name	Time	Method
Change in metabolic variables (Weight, kg) (Height, m) (Body Mass Index BMI)	Change from baseline visit to final 3-month period	Average baseline and final visit (Weight, kg) (Height, m) in combination for BMI (Body Mass Index, kg/m2)
Change in metabolic variables (Waist Circumference WC, cm)	Change from baseline visit to final 3-month period	Average baseline and final visit (Waist Circumference WC, cm)
Change in metabolic variables (% fat, % visceral fat)	Change from baseline visit to final 3-month period	Average baseline and final visit (% fat, % visceral fat)
Change in metabolic variables (Muscle Mass MM, kg)	Change from baseline visit to final 3-month period	Average baseline and final visit (Muscle Mass MM, kg)

Trial Locations

Locations (1)

Universidad de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico