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OpenTrials
Completed

NCT Number: NCT06961279

Resveratrol Stimulates Insulin Sensitivity in Subjects With Obesity and Insulin Resistance

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol

Dietary Supplement

Administered orally once every 12 hours

Placebo

Dietary Supplement

Administered orally once every 12 hours

Primary outcomes

  1. Insulin sensitivity

    Time frame: Baseline to 2 months

    Measurement of insulin by an oral glucose tolerance test.

Secondary outcomes

  1. Fecal microbiota

    Time frame: Baseline to 2 months

    Composition, abundance and diversity of fecal microbiota by sequencing 16s rRNA gene

  2. Glucose metabolism profile

    Time frame: Baseline to 2 months

    Serum glucose (mg/dL)

  3. Insulin (µUI/ml)

    Time frame: Baseline to 2 months

    Serum insulin

  4. Triglycerides

    Time frame: Baseline to 2 months

    serum triglycerides (mg/dL)

  5. Total cholesterol

    Time frame: Baseline to 2 months

    serum total cholesterol (mg/dL)

  6. LDL cholesterol

    Time frame: Baseline to 2 months

    serum LDL cholesterol (mg/dL)

  7. HDL cholesterol

    Time frame: Baseline to 2 months

    serum HDL cholesterol (mg/dL)

  8. Antioxidant profile

    Time frame: Baseline to 2 months

    Serum malondialdehyde (MDA) (nmol/mL)

  9. Body weight

    Time frame: Baseline to 2 months

    body wight (kg)

  10. Blood pressure

    Time frame: Baseline to 2 months

    blood pressure (mmHg)

  11. Change in PGC1α content

    Time frame: Through study completion, an average of 2 months

    Measure of PGC1α protein content in skeletal muscle tissue taken by biopsy

  12. Change in AMPK content

    Time frame: Through study completion, an average of 2 months

    Measure of AMPK protein content in skeletal muscle tissue taken by biopsy

  13. Succinate dehydrogenase

    Time frame: Through study completion, an average of 2 months

    Fold change in succinate dehydrogenase activity in skeletal muscle tissue taken by biopsy

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

Resveratrol Stimulates Insulin Sensitivity, and Changes Microbiota Taxonomy and Serum Metabolomics in Participants With Obesity and Insulin Resistance

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
May 7, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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