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Effect of Resveratrol and Vitamin C on Insulin Resistance Among Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT03090997
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Brief 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. 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

Condition or disease Intervention/treatment Phase
Postmenopausal Insulin Resistance Dietary Supplement: vitamin C (500 mg / day) + placebo Dietary Supplement: resveratrol (500 mg / day) + placebo Dietary Supplement: vitamin C (500 mg / day) and resveratrol (500 mg / day) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participant, care provider, investigator and outcomes assesor will be masking using placebo for resveratrol and vitamin C, the three groups will receive the same intervention with the use of placebo. The placebo will be prepared for the Pharmacology Department and packing and label for exclusive use into the protocol study. Any participant, care provider or investigator will know if package content vitamin C, resveratrol or placebo.
Primary Purpose: Treatment
Official Title: Effect of Resveratrol and Vitamin C on Insulin Resistance and Antioxidant Capacity in Postmenopausal Women. A Randomized Clinical Trial
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : August 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group 1
vitamin C (500 mg/day/orally) + placebo
Dietary Supplement: vitamin C (500 mg / day) + placebo
Adminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol)

Placebo Comparator: Group 2
resveratrol (500 mg/day/orally) + placebo
Dietary Supplement: resveratrol (500 mg / day) + placebo
Adminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C)

Active Comparator: Group 3
vitamin C (500 mg/day/orally) + resveratrol (500 mg/day/orally)
Dietary Supplement: vitamin C (500 mg / day) and resveratrol (500 mg / day)
Adminstration of resveratrol (500 mg / day/orally) + vitamin C 500 mg/day/orally)




Primary Outcome Measures :
  1. Insulin resistance [ Time Frame: HOMA at 3 months after starting the intervention in each group ]
    Insulin resistance measured by HOMA (Homeostatic Model Assessment)


Secondary Outcome Measures :
  1. Superoxide dismutase activity [ Time Frame: three months after starting the intervention ]
    Enzymatic activity measured by spectrophotometry

  2. Catalase activity [ Time Frame: three months after starting the intervention ]
    Enzymatic activity measured by spectrophotometry

  3. Glutathione peroxidase activity [ Time Frame: three months after starting the intervention ]
    Enzymatic activity measured by spectrophotometry

  4. Glutathione reductase activity [ Time Frame: three months after starting the intervention ]
    Enzymatic activity measured by spectrophotometry

  5. Malondialdehyde [ Time Frame: three months after starting the intervention ]
    Enzymatic activity measured by spectrophotometry

  6. Carbonylation of proteins [ Time Frame: three months after starting the intervention ]
    Marker of oxidative stress measured by spectrophotometry



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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090997


Contacts
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Contact: Araceli Montoya-Estrada, PhD +525555209900 ext 257 ara_mones@hotmail.com
Contact: Enrique Reyes-Muñoz, PhD +525555209900 ext 299 dr.enriquereyes@gmail.com

Locations
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Mexico
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes Recruiting
Mexico City, Mexico, 11000
Contact: Araceli Montoya-Estrada, MD    +525555209900 ext 257    ara_mones@hotmail.com   
Contact: Enrique Reyes-Muñoz, MD, PhD.    +525555209900 ext 307    dr.enriquereyes@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Investigators
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Principal Investigator: Araceli Montoya-Estrada, PhD Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Study Chair: Guillermo F Ortiz-Luna, MD Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

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Responsible Party: ENRIQUE REYES-Munoz MD, Clinical Professor, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier: NCT03090997     History of Changes
Other Study ID Numbers: 3210-10209-01-574-17
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
resveratrol, vitamin C, antioxidant therapy, antioxidant capacity
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vitamins
Ascorbic Acid
Resveratrol
Antioxidants
Physiological Effects of Drugs
Micronutrients
Nutrients
Growth Substances
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents