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

• Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03090997
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 48.4
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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)	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Clinical TrialRandomized 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: Feb 15, 2018
• Anticipated Primary Completion Date: Jan 30, 2022
• Anticipated Study Completion Date: Feb 28, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Insulin resistance [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 [three months after starting the intervention]

   Enzymatic activity measured by spectrophotometry

2. Catalase activity [three months after starting the intervention]

   Enzymatic activity measured by spectrophotometry

3. Glutathione peroxidase activity [three months after starting the intervention]

   Enzymatic activity measured by spectrophotometry

4. Glutathione reductase activity [three months after starting the intervention]

   Enzymatic activity measured by spectrophotometry

5. Malondialdehyde [three months after starting the intervention]

   Enzymatic activity measured by spectrophotometry

6. Carbonylation of proteins [three months after starting the intervention]

   Marker of oxidative stress measured by spectrophotometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Perinatología Isidro Espinosa de los Reyes	Mexico City		Mexico	11000

Sponsors and Collaborators

• Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ENRIQUE REYES-Munoz MD, Clinical Professor, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• ClinicalTrials.gov Identifier: NCT03090997
• Other Study ID Numbers: 3210-10209-01-574-17
• First Posted: Mar 27, 2017
• Last Update Posted: Dec 28, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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, Clinical Professor, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes: resveratrol, vitamin C, antioxidant therapy, antioxidant capacity
• Additional relevant MeSH terms: Insulin Resistance; Vitamins; Ascorbic Acid; Resveratrol

Study Results

No Results Posted as of Dec 28, 2021