Resveratrol Stimulates Insulin Sensitivity in Subjects With Obesity and Insulin Resistance

NCT06961279 | Completed DMC

• 1 other identifier: 1099A
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

There is evidence that resveratrol can improve insulin resistance in rodents and humans with obesity and it can also improve muscle mitochondrial content mediated through activation of AMPK. However, little is known if this improvement is associated with changes in the gut microbiota and how gut microbiota is associated with serum metabolites after consumption of resveratrol. In the present study, the investigators show that the consumption of resveratrol for 2 months could influence insulin sensitivity in subjects with obesity. This effect will be accompanied by a modification of the microbiota taxonomy and the metabolites derived from this. Consequently, there will be a reduction in metabolic endotoxemia accompanied by an increase in AMP-activated protein kinase (AMPK) phosphorylation and the expression of genes of mitochondrial biogenesis in skeletal muscle.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Measurement of insulin by an oral glucose tolerance test.

  Baseline to 2 months

Secondary Outcomes (13)

• Fecal microbiota

  Baseline to 2 months

• Glucose metabolism profile

  Baseline to 2 months

• Insulin (µUI/ml)

  Baseline to 2 months

• Triglycerides

  Baseline to 2 months

• Total cholesterol

  Baseline to 2 months

Study Arms (2)

Resveratrol

EXPERIMENTAL

Resveratrol capsules of 75 mg each, 150 mg/day

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

Maltodextrin capsules, administered orally once every 12 hours

Dietary Supplement: Placebo

Interventions

Resveratrol DIETARY_SUPPLEMENT

Administered orally once every 12 hours

Resveratrol

Placebo DIETARY_SUPPLEMENT

Administered orally once every 12 hours

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female.
• Between 20 and 60 years
• BMI ≥ 30 and ≤ 40 kg/m2
• Presence of insulin resistance (HOMA-IR index ≥ 2.5)
• Willing and able to sign written informed consent prior to trial entry

You may not qualify if:

• Patients with any type of diabetes.
• Patients with kidney disease diagnosed by a medical or with creatinine\> 1.3 mg / dL for men and \> 1.1 mg / dL for women and / or BUN\> 20 mg / dL.
• Patients with acquired diseases that produce obesity and diabetes secondarily.
• Patients who have suffered a cardiovascular event.
• Patients with gastrointestinal diseases.
• Weight loss \> 3 kg in the last 3 months.
• Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
• Pregnancy status.
• Antibiotic consumption 3 months prior to the study.
• Be an undergraduate or graduate student within the Institute.
• Positive smoking.
• Drug treatment:
• Antihypertensive drugs or treatment
• Treatment with hypoglycemic agents or insulin and antidiabetic drugs.
• Treatment with statins, fibrates or other drugs to control dyslipidemia.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Mexico City, Mexico

Location

MeSH Terms

Conditions

Obesity

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Armando R Tovar, Dr.

  INCMNSZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: September 15, 2013
• Primary Completion: December 15, 2017
• Study Completion: December 1, 2018
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)