Resveratrol Stimulates Insulin Sensitivity in Subjects With Obesity and Insulin Resistance

NCT ID: NCT06961279

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-15
• Study Completion Date: 2018-12-01

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.

Detailed Description

The investigators included 38 participants who met the following inclusion criteria: adults between 20 and 60 years of age with a diagnosis of HOMA-IR index greater than 2.5, and BMI ≥30 and ≤ 40 kg / m2 and who signed the consent letter. Participants who had any added pathology, pregnancy, smoking or consumed medications were excluded. Once the letter of informed consent was accepted, the patients were assigned to the respective treatment group. These individuals were advised to consume the recommended diet for subjects with obesity. Participants were randomly distributed to consume a) placebo treatment or b) resveratrol capsules (150 mg/day). The participants were followed for 2 months. In the pre-randomization visit, informed consent letters were given, and blood samples were taken to evaluate glucose concentration, lipid profile and serum insulin, blood pressure, body weight and height and body composition. The presence of insulin resistance was determined by means of the HOMA-IR index. For the first visit body composition, other biochemical parameters such as protein c reactive, alanine transaminase, aspartate transaminase, hemoglobin glycosylated, hormones as leptin and adiponectin, free fatty acids in serum, malondialdehyde in serum, lipopolysaccharide in serum, short chain fatty acids in feces, fecal microbiota and serum metabolomics were determined. After 2 months, the same variables were assessed, and an expert surgeon in the operating room performed a vastus lateralis muscle biopsy, then protein extraction was performed.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Resveratrol

Resveratrol capsules of 75 mg each, 150 mg/day

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Administered orally once every 12 hours

Placebo

Maltodextrin capsules, administered orally once every 12 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Administered orally once every 12 hours

Interventions

Resveratrol

Administered orally once every 12 hours

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Administered orally once every 12 hours

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Use of antibiotics in the three months prior to the study.
• Use of steroid drugs, chemotherapy, immunosuppressants, or radiation therapy.
• Anorexigenic or that accelerate weight loss such as sibutramine or orlistat.
• Probiotic, prebiotic or symbiotic supplements.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armando R Tovar, Dr.

Role: PRINCIPAL_INVESTIGATOR

INCMNSZ

Locations

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

1099A

Identifier Type: -

Identifier Source: org_study_id