Effect of Cocoa Polyphenols Supplementation on Cardiovascular Risk of Postmenopausal Women

NCT05158673 | Unknown

• 1 other identifier: 2020-1-29
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Several epidemiological studies have shown that premenopausal women are protected from cardiovascular diseases compared to men of the same age; however, after menopause (postmenopause), the cardiovascular risk increases progressively to equal the cardiovascular risk of men of the same age group. In addition, in Mexico, the incidence of women entering the postmenopausal stage with overweight or obesity increases each year. Therefore, it is essential to generate public initiatives to reduce the metabolic and physiological alterations caused by overweight/obesity and improve postmenopausal women's health and quality of life. Flavonoids are bioactive compounds that have been shown to reduce the cardiovascular risk associated with obesity since they participate in the regulation of lipid metabolism, improve body composition, reduce oxidative stress and inflammation; Therefore, our objective is to reduce the cardiovascular risk of postmenopausal women and improve the oxidative and inflammatory state, through oral supplementation with cocoa flavonoids. To do this, an innovative method will be used to assess cardiovascular risk based on knowledge of the type, number, and size of lipoprotein particles and knowing the oxidative and inflammatory state before and after supplementation with cocoa flavonoids.

Conditions

Metabolic Syndrome

Keywords

flavonoids; cocoa; postmenopausal women; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Number of participants with Metabolic Syndrome

  Metabolic syndrome according to International Diabetes Federation Criteria

  Metabolic Syndrome at three months after starting the intervention in each group

Secondary Outcomes (6)

• Carbonylation of proteins

  Three months after starting the intervention in each group

• Malondialdehyde

  Three months after starting the intervention in each group

• Superoxide Dismutase activity

  Three months after starting the intervention in each group

• Catalase activity

  Three months after starting the intervention in each group

• Lipid profile quantification

  Three months after starting the intervention in each group

Study Arms (2)

Group A (Placebo)

PLACEBO COMPARATOR

The administration of two capsules of 500 mg orally of placebo (excipient q.s. starch capsule) 1 every 12 hours, for 12 weeks.

Dietary Supplement: Placebo of Cocoa flavonoids

Group B (Flavonoid)

ACTIVE COMPARATOR

Two capsules of 500 mg of the flavonoid supplement (whose total flavonoid content is 15 mg/capsule) orally every 12 hours for 12 weeks.

Dietary Supplement: Cocoa flavonoids

Interventions

Placebo of Cocoa flavonoids DIETARY_SUPPLEMENT

Dietary supplement: The administration of two capsules of 500 mg orally of placebo (excipient q.s. starch capsule) 1 every 12 hours, for 12 weeks

Group A (Placebo)

Cocoa flavonoids DIETARY_SUPPLEMENT

Dietary supplement: Two 500 mg capsules of the flavonoid supplement (whose total flavonoid content is 15 mg/capsule) orally every 12 hours (one in the morning and one at night) for 12 weeks

Group B (Flavonoid)

Eligibility Criteria

• Age: 50 Years - 60 Years
• Gender Eligibility Details: Women with an early postmenopause diagnosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• According to the STRAW classification (+ 1A + 1B + 1C), women with an early postmenopause diagnosis attend the INPerIER Peri and Postmenopause Clinic.
• Age between 50 and 60 years.
• who have metabolic syndrome
• Who present an altered lipid and glycemic profile that have not reached the critical point of pharmacological treatment (blood glucose between 100 and 125 mg/dl, cholesterol between 200 and 280 mg/dl, triglycerides between 150 and 300 mg/dl, lower HDL 50 mg/dl).
• That they are not taking metformin
• That they have not taken metformin in the three months before entering the study.
• That they are not taking bezafibrate and/or statins.
• That they have not taken bezafibrate and/or statins in the three months before entering the study.
• No indication for hormone replacement therapy.
• That they sign the informed consent.

You may not qualify if:

• Women who present pathologies such as Diabetes Mellitus, rheumatoid arthritis, lupus, neoplasms of any type, HIV, or kidney diseases during the development of the study.
• Women who require hormone replacement therapy during the development of the protocol.
• That the patient has any surgical intervention during the development of the study.
• Women who consume or require the use of lipid-lowering drugs during the development of the protocol

Sponsors & Collaborators

• Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes: lead
• National Polytechnic Institute, Mexico: collaborator

Study Sites (1)

Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

Mexico City, 11000, Mexico

Location

Related Publications (2)

• Goya L, Martin MA, Sarria B, Ramos S, Mateos R, Bravo L. Effect of Cocoa and Its Flavonoids on Biomarkers of Inflammation: Studies of Cell Culture, Animals and Humans. Nutrients. 2016 Apr 9;8(4):212. doi: 10.3390/nu8040212.

  PMID: 27070643 BACKGROUND

• Gutierrez-Salmean G, Meaney E, Lanaspa MA, Cicerchi C, Johnson RJ, Dugar S, Taub P, Ramirez-Sanchez I, Villarreal F, Schreiner G, Ceballos G. A randomized, placebo-controlled, double-blind study on the effects of (-)-epicatechin on the triglyceride/HDLc ratio and cardiometabolic profile of subjects with hypertriglyceridemia: Unique in vitro effects. Int J Cardiol. 2016 Nov 15;223:500-506. doi: 10.1016/j.ijcard.2016.08.158. Epub 2016 Aug 8.

  PMID: 27552564 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Araceli Montoya-Estrada, PhD

  Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

  PRINCIPAL INVESTIGATOR

• Nayelli Najera, PhD

  Instituto Politecnico Nacional

  STUDY DIRECTOR

Central Study Contacts

Araceli Montoya-Estrada, PhD

CONTACT

525555209900; ara_mones@hotmail.com

Nayelli Najéra, PhD

CONTACT

525557296000; nnajerag@ipn.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized Clinical Trial only the principal investigator is not blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 15, 2021
• Study Start: January 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)