PostmenopausalNCT03090997
Effect of Resveratrol and Vitamin C on Insulin Resistance Among Postmenopausal Women
A study testing vitamin C (500 mg / day) and resveratrol (500 mg / day) in people with Postmenopausal and Insulin Resistance, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
Trial summary
Hormonal and metabolic changes because of postmenopause increase body weight, central abdominal fat, alter lipid profile and insulin resistance, those factors increase the risk up to 60% to develop metabolic syndrome, diabetes and cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Postmenopausal, Insulin Resistance
- What is being tested?
- vitamin C (500 mg / day) and resveratrol (500 mg / day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteMexico
- Study dates
- 15 Feb 2018to 28 Feb 2022
- 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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with early postmenopause according to STRAW classification.
- Insulin resistance determinated by HOMA ≥ 2.5.
- Not use of metformin, bezafibrates and / or statins, three months before enter to the study
- No indication of hormone replacement therapy.
- Sign the informed consent.
Who cannot join
- Women who present pathologies such as: Diabetes Mellitus, rheumatoid arthritis, lupus, neoplasms of any type, HIV, or kidney disease during the course of the study.
- Women who during the development of the protocol require hormone replacement therapy.
- Any type of surgical intervention during the following of the study.
- That the patient wishes to withdraw from the study.
- That the patient does not complete with 80% of adherence to the treatment
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Mexico City, 11000
About this study
Official title: Effect of Resveratrol and Vitamin C on Insulin Resistance and Antioxidant Capacity in Postmenopausal Women. A Randomized Clinical Trial
Hormonal and metabolic changes because of postmenopause increase body weight, central abdominal fat, alter lipid profile and insulin resistance, those factors increase the risk up to 60% to develop metabolic syndrome, diabetes and cardiovascular diseases. Because there is no efficient antioxidant therapy in postmenopausal women, this study proposes a therapy with resveratrol and vitamin C to increase the total antioxidant capacity; as well as to decrease insulin resistance and in consequence decreased the risk of diabetes, metabolic syndrome and cardiovascular disease
Read the detailed description
Currently, there are not studies that demonstrate an efficient antioxidant therapy in postmenopausal women, to increase the total antioxidant capacity and to decrease insulin resistance and biochemical parameters of cardio-metabolic risk. Therefore, the aim of this study is to evaluate the effect of the co-administration of resveratrol and vitamin C on insulin resistance and antioxidant capacity by a double-blind randomized clinical trial. A population of 270 postmenopausal women will be studied, stratified into 3 groups:
Group 1: Three-month administration of vitamin C 500 mg daily + placebo Group 2: Three-month administration of resveratrol 500 mg daily + placebo Group 3: Three months administration of vitamin C 500 mg daily and resveratrol 500 mg daily as antioxidant therapy.
All participants will be monitored monthly for a period of 3 months: glucose, insulin, uric acid, Homeostatic Model Assessment (HOMA), total cholesterol (TC), triglycerides (TGC), High density lipoproteins-cholesterol (HDL- C), low density lipoproteins-cholesterol (LDL), blood pressure, body mass index (BMI). The antioxidant efficiency in erythrocytes by the quantification of antioxidant enzymes (superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase), as well as total antioxidant capacity in plasma. In order to corroborate the oxidative damage, the product of the lipoperoxidation malondialdehyde and the carbonylation of proteins will be evaluated by spectrophotometric techniques before and three months after the intervention.
- Conditions
- Postmenopausal, Insulin Resistance
- Being tested
- vitamin C (500 mg / day) + placebo, resveratrol (500 mg / day) + placebo, vitamin C (500 mg / day) and resveratrol (500 mg / day)
- Keywords
- resveratrol, vitamin C, antioxidant therapy, antioxidant capacity
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin C (500 mg / day) + placeboDietary supplement
Adminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol)
resveratrol (500 mg / day) + placeboDietary supplement
Adminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C)
vitamin C (500 mg / day) and resveratrol (500 mg / day)Dietary supplement
Adminstration of resveratrol (500 mg / day/orally) + vitamin C 500 mg/day/orally)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | vitamin C (500 mg/day/orally) + placebo Receives: Dietary Supplement: vitamin C (500 mg / day) + placebo |
| Group 2 | Placebo comparator | resveratrol (500 mg/day/orally) + placebo Receives: Dietary Supplement: resveratrol (500 mg / day) + placebo |
| Group 3 | Active comparator | vitamin C (500 mg/day/orally) + resveratrol (500 mg/day/orally) Receives: Dietary Supplement: vitamin C (500 mg / day) and resveratrol (500 mg / day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
Insulin resistance measured by HOMA (Homeostatic Model Assessment)
Measured: HOMA at 3 months after starting the intervention in each group
Secondary outcomes (6)
Superoxide dismutase activity
Enzymatic activity measured by spectrophotometry
Measured: three months after starting the intervention
Catalase activity
Enzymatic activity measured by spectrophotometry
Measured: three months after starting the intervention
Glutathione peroxidase activity
Enzymatic activity measured by spectrophotometry
Measured: three months after starting the intervention
Glutathione reductase activity
Enzymatic activity measured by spectrophotometry
Measured: three months after starting the intervention
Malondialdehyde
Enzymatic activity measured by spectrophotometry
Measured: three months after starting the intervention
Carbonylation of proteins
Marker of oxidative stress measured by spectrophotometry
Measured: three months after starting the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start15 Feb 2018
- Primary completion30 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies 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
- Model description
- Randomized Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Investigators
- Araceli Montoya-Estrada, PhD, Principal investigator, Instituto Nacional de Perinatología Isidro Espinosa de los ReyesGuillermo F Ortiz-Luna, MD, Study chair, Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090997
- Sponsor's protocol ID
- 3210-10209-01-574-17
- Status last verified
- Dec 2021
- First submitted
- 16 Mar 2017
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resveratrol and Vitamin C on Insulin Resistance and Antioxidant Capacity in Postmenopausal Women. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03090997
- Acronym / sponsor ID
- 3210-10209-01-574-17
- Conditions
- Postmenopausal, Insulin Resistance
- Keywords
- resveratrol, vitamin C, antioxidant therapy, antioxidant capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 27 Mar 2017 (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.
Hormonal and metabolic changes because of postmenopause increase body weight, central abdominal fat, alter lipid profile and insulin resistance, those factors increase the risk up to 60% to develop metabolic syndrome, diabetes and cardiovascular diseases. Because there is no efficient antioxidant therapy in postmenopausal women, this study proposes a therapy with resveratrol and vitamin C to increase the total antioxidant capacity; as well as to decrease insulin resistance and in consequence decreased the risk of diabetes, metabolic syndrome and cardiovascular disease
Detailed description
Currently, there are not studies that demonstrate an efficient antioxidant therapy in postmenopausal women, to increase the total antioxidant capacity and to decrease insulin resistance and biochemical parameters of cardio-metabolic risk. Therefore, the aim of this study is to evaluate the effect of the co-administration of resveratrol and vitamin C on insulin resistance and antioxidant capacity by a double-blind randomized clinical trial. A population of 270 postmenopausal women will be studied, stratified into 3 groups:
Group 1: Three-month administration of vitamin C 500 mg daily + placebo Group 2: Three-month administration of resveratrol 500 mg daily + placebo Group 3: Three months administration of vitamin C 500 mg daily and resveratrol 500 mg daily as antioxidant therapy.
All participants will be monitored monthly for a period of 3 months: glucose, insulin, uric acid, Homeostatic Model Assessment (HOMA), total cholesterol (TC), triglycerides (TGC), High density lipoproteins-cholesterol (HDL- C), low density lipoproteins-cholesterol (LDL), blood pressure, body mass index (BMI). The antioxidant efficiency in erythrocytes by the quantification of antioxidant enzymes (superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase), as well as total antioxidant capacity in plasma. In order to corroborate the oxidative damage, the product of the lipoperoxidation malondialdehyde and the carbonylation of proteins will be evaluated by spectrophotometric techniques before and three months after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Dietary Supplement: vitamin C (500 mg / day) + placebovitamin C (500 mg/day/orally) + placebo |
| Group 2 | Placebo comparator | Dietary Supplement: resveratrol (500 mg / day) + placeboresveratrol (500 mg/day/orally) + placebo |
| Group 3 | Active comparator | Dietary Supplement: vitamin C (500 mg / day) and resveratrol (500 mg / day)vitamin C (500 mg/day/orally) + resveratrol (500 mg/day/orally) |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women diagnosed with early postmenopause according to STRAW classification.
- Insulin resistance determinated by HOMA ≥ 2.5.
- Not use of metformin, bezafibrates and / or statins, three months before enter to the study
- No indication of hormone replacement therapy.
- Sign the informed consent.
Key exclusion criteria (5 listed)
- Women who present pathologies such as: Diabetes Mellitus, rheumatoid arthritis, lupus, neoplasms of any type, HIV, or kidney disease during the course of the study.
- Women who during the development of the protocol require hormone replacement therapy.
- Any type of surgical intervention during the following of the study.
- That the patient wishes to withdraw from the study.
- That the patient does not complete with 80% of adherence to the treatment
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 |
|---|---|---|
| vitamin C (500 mg / day) + placeboAdminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol) | Dietary supplement | Group 1 |
| resveratrol (500 mg / day) + placeboAdminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C) | Dietary supplement | Group 2 |
| vitamin C (500 mg / day) and resveratrol (500 mg / day)Adminstration of resveratrol (500 mg / day/orally) + vitamin C 500 mg/day/orally) | Dietary supplement | Group 3 |
Primary outcome
Insulin resistance
Time frame: HOMA at 3 months after starting the intervention in each group
Insulin resistance measured by HOMA (Homeostatic Model Assessment)
6 secondary outcomes
Superoxide dismutase activity
Time frame: three months after starting the intervention
Catalase activity
Time frame: three months after starting the intervention
Glutathione peroxidase activity
Time frame: three months after starting the intervention
Glutathione reductase activity
Time frame: three months after starting the intervention
Malondialdehyde
Time frame: three months after starting the intervention
Carbonylation of proteins
Time frame: three months after starting the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Araceli Montoya-Estrada, PhD principal investigator
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Guillermo F Ortiz-Luna, MD study chair
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin C (500 mg / day) and resveratrol (500 mg / day) in people with Postmenopausal and Insulin Resistance, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes 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 5 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: status not confirmed, as of the sponsor's last update on 28 Dec 2021. 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?
Results are not available in the source record.
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 resistance (time frame: HOMA at 3 months after starting the intervention in each group). 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 28 Dec 2021.