ObesityNCT06961279
Resveratrol Stimulates Insulin Sensitivity in Subjects With Obesity and Insulin Resistance
A study testing Resveratrol in people with Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteMexico
- Study dates
- 15 Sep 2013to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
Mexico City
About this study
Official title: Resveratrol Stimulates Insulin Sensitivity, and Changes Microbiota Taxonomy and Serum Metabolomics in Participants 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.
Read the 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
- Being tested
- Resveratrol, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Administered orally once every 12 hours
PlaceboDietary supplement
Administered orally once every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Resveratrol capsules of 75 mg each, 150 mg/day Receives: Dietary Supplement: Resveratrol |
| Placebo | Placebo comparator | Maltodextrin capsules, administered orally once every 12 hours Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measurement of insulin by an oral glucose tolerance test.
Measured: Baseline to 2 months
Secondary outcomes (13)
Fecal microbiota
Composition, abundance and diversity of fecal microbiota by sequencing 16s rRNA gene
Measured: Baseline to 2 months
Glucose metabolism profile
Serum glucose (mg/dL)
Measured: Baseline to 2 months
Insulin (µUI/ml)
Serum insulin
Measured: Baseline to 2 months
Triglycerides
serum triglycerides (mg/dL)
Measured: Baseline to 2 months
Total cholesterol
serum total cholesterol (mg/dL)
Measured: Baseline to 2 months
LDL cholesterol
serum LDL cholesterol (mg/dL)
Measured: Baseline to 2 months
HDL cholesterol
serum HDL cholesterol (mg/dL)
Measured: Baseline to 2 months
Antioxidant profile
Serum malondialdehyde (MDA) (nmol/mL)
Measured: Baseline to 2 months
Body weight
body wight (kg)
Measured: Baseline to 2 months
Blood pressure
blood pressure (mmHg)
Measured: Baseline to 2 months
Change in PGC1α content
Measure of PGC1α protein content in skeletal muscle tissue taken by biopsy
Measured: Through study completion, an average of 2 months
Change in AMPK content
Measure of AMPK protein content in skeletal muscle tissue taken by biopsy
Measured: Through study completion, an average of 2 months
Succinate dehydrogenase
Fold change in succinate dehydrogenase activity in skeletal muscle tissue taken by biopsy
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start15 Sep 2013
- Primary completion15 Dec 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armando R Tovar, Dr., Principal investigator, INCMNSZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961279
- Sponsor's protocol ID
- 1099A
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resveratrol Stimulates Insulin Sensitivity, and Changes Microbiota Taxonomy and Serum Metabolomics in Participants With Obesity and Insulin Resistance
- ClinicalTrials.gov ID
- NCT06961279
- Acronym / sponsor ID
- 1099A
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 15 Sep 2013 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: ResveratrolResveratrol capsules of 75 mg each, 150 mg/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin capsules, administered orally once every 12 hours |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolAdministered orally once every 12 hours | Dietary supplement | Resveratrol |
| PlaceboAdministered orally once every 12 hours | Dietary supplement | Placebo |
Primary outcome
Insulin sensitivity
Time frame: Baseline to 2 months
Measurement of insulin by an oral glucose tolerance test.
13 secondary outcomes
Fecal microbiota
Time frame: Baseline to 2 months
Glucose metabolism profile
Time frame: Baseline to 2 months
Insulin (µUI/ml)
Time frame: Baseline to 2 months
Triglycerides
Time frame: Baseline to 2 months
Total cholesterol
Time frame: Baseline to 2 months
LDL cholesterol
Time frame: Baseline to 2 months
HDL cholesterol
Time frame: Baseline to 2 months
Antioxidant profile
Time frame: Baseline to 2 months
Body weight
Time frame: Baseline to 2 months
Blood pressure
Time frame: Baseline to 2 months
Change in PGC1α content
Time frame: Through study completion, an average of 2 months
Change in AMPK content
Time frame: Through study completion, an average of 2 months
Succinate dehydrogenase
Time frame: Through study completion, an average of 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando R Tovar, Dr. principal investigator
INCMNSZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol in people with Obesity, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Baseline to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.