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Effect of Cocoa Polyphenols Supplementation on Cardiovascular Risk of Postmenopausal Women

Primary Purpose

Metabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Placebo of Cocoa flavonoids
Cocoa flavonoids
Sponsored by
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring flavonoids, cocoa, postmenopausal women, metabolic syndrome

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • -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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group A (Placebo)

Group B (Flavonoid)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with Metabolic Syndrome
Metabolic syndrome according to International Diabetes Federation Criteria

Secondary Outcome Measures

Carbonylation of proteins
Marker of oxidative stress measured by spectrophotometry expressed as pmol PC/mg protein
Malondialdehyde
Marker of oxidative stress measured by spectrophotometry expressed as pmol MDA/mg dry weight
Superoxide Dismutase activity
Enzymatic activity measured by Colorimetric Activity Kit expressed as nmol/min/mL
Catalase activity
Enzymatic activity measured by Colorimetric Activity Kit expressed as nmol/min/mL
Lipid profile quantification
size of cholesterol (main classes and subclasses of lipoproteins) expressed in large, medium and small)
IL-4, IL-6, IL10 and TNFa
They will be quantified by ELISA technique expressed in pg/ul

Full Information

First Posted
November 17, 2021
Last Updated
December 14, 2021
Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Collaborators
National Polytechnic Institute, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT05158673
Brief Title
Effect of Cocoa Polyphenols Supplementation on Cardiovascular Risk of Postmenopausal Women
Official Title
Effect of Cocoa Polyphenols Supplementation on Cardiovascular Risk of Overweight or Obese Postmenopausal Women: Double Blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Collaborators
National Polytechnic Institute, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Some interventions have been carried out to reduce obesity and the incidence of cardio-metabolic pathologies since the foods consumed in the daily diet, directly and indirectly, influence the modulation of metabolic signaling pathways. Flavonoids, nutrients of plant origin, have beneficial effects on health since they can prevent and reduce the impact of overweight/obesity. Significant benefits have also been shown in blood pressure, platelet reactivity, HDL cholesterol, LDL cholesterol, insulin sensitivity, and prostaglandin metabolism, improving health in patients with chronic diseases related to metabolic disorders and OS. Food rich in flavonoids is cocoa; the plant contains many polyphenols (anthocyanidins, proanthocyanidins, and catechins), concentrated mainly in the pods and seeds, which provides a highly bitter taste. The polyphenols that can be identified in cocoa beans are (-) - epicatechin and, to a lesser extent (+) - catechin, (+) - gallocatechin, and (-) - epigallocatechin. Polyphenols derived from cocoa are characterized by being powerful antioxidants, by having effects on muscle and fat tissue: inducing the darkening of adipocytes (change from white adipocytes (fat deposit) to beige adipocytes; promoting mitochondrial biogenesis; increasing the expression of vital thermogenic genes and upstream regulators of fatty acid oxidation; reducing serum TG concentrations; phosphorylating metabolism regulators and acetylating (activating) proteins involved in mitochondrial structure and function. Actions culminate in regulating the metabolic profile, decreasing adipose tissue, increasing muscle mass, and, therefore, decreasing BMI. There is evidence of the beneficial effects of cocoa polyphenols as antioxidants, improving the lipid profile levels and pro and anti-inflammatory markers. Cocoa is one of the foods of natural origin with high antioxidant capacity due to the tricyclic structure of flavonoids. The compounds act as electron donors and stabilize free radicals through their aromatic rings with hydroxyl substituents. Cocoa polyphenols have been shown to protect cells from oxidative stress at the membrane level by reducing lipoperoxidation and DNA damage through the chelating action of the catechol group and hydroxyl substituents. Furthermore, cocoa flavonoids inhibit xanthine oxidase, NADPH-oxidase, tyrosine kinases, and protein kinases. Cocoa polyphenols have been shown to have antioxidant activity that helps counteract the atherosclerotic process by reducing the activation of NADPH oxidase. In addition, to improve the dilation of the arteries in smoking patients with atherosclerosis. The antioxidants in cocoa inhibit LDL oxidation, which is related to delaying atherosclerotic progression by reducing ox-LDL and increasing HDL-c.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
flavonoids, cocoa, postmenopausal women, metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomized Clinical Trial only the principal investigator is not blinded
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Placebo)
Arm Type
Placebo Comparator
Arm Description
The administration of two capsules of 500 mg orally of placebo (excipient q.s. starch capsule) 1 every 12 hours, for 12 weeks.
Arm Title
Group B (Flavonoid)
Arm Type
Active Comparator
Arm Description
Two capsules of 500 mg of the flavonoid supplement (whose total flavonoid content is 15 mg/capsule) orally every 12 hours for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo of Cocoa flavonoids
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Cocoa flavonoids
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with Metabolic Syndrome
Description
Metabolic syndrome according to International Diabetes Federation Criteria
Time Frame
Metabolic Syndrome at three months after starting the intervention in each group
Secondary Outcome Measure Information:
Title
Carbonylation of proteins
Description
Marker of oxidative stress measured by spectrophotometry expressed as pmol PC/mg protein
Time Frame
Three months after starting the intervention in each group
Title
Malondialdehyde
Description
Marker of oxidative stress measured by spectrophotometry expressed as pmol MDA/mg dry weight
Time Frame
Three months after starting the intervention in each group
Title
Superoxide Dismutase activity
Description
Enzymatic activity measured by Colorimetric Activity Kit expressed as nmol/min/mL
Time Frame
Three months after starting the intervention in each group
Title
Catalase activity
Description
Enzymatic activity measured by Colorimetric Activity Kit expressed as nmol/min/mL
Time Frame
Three months after starting the intervention in each group
Title
Lipid profile quantification
Description
size of cholesterol (main classes and subclasses of lipoproteins) expressed in large, medium and small)
Time Frame
Three months after starting the intervention in each group
Title
IL-4, IL-6, IL10 and TNFa
Description
They will be quantified by ELISA technique expressed in pg/ul
Time Frame
Three months after starting the intervention in each group

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with an early postmenopause diagnosis
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Araceli Montoya-Estrada, PhD
Phone
525555209900
Ext
307
Email
ara_mones@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nayelli Najéra, PhD
Phone
525557296000
Ext
62820
Email
nnajerag@ipn.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Araceli Montoya-Estrada, PhD
Organizational Affiliation
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nayelli Najera, PhD
Organizational Affiliation
Instituto Politecnico Nacional
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
City
Mexico City
ZIP/Postal Code
11000
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Araceli Montoya-Estrada, PhD
Phone
+52 5555209900
Ext
307
Email
ara_mones@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guillermo Ceballos, PhD
First Name & Middle Initial & Last Name & Degree
Nayelli Najera, PhD
First Name & Middle Initial & Last Name & Degree
Guillermo Ortiz-Luna, MD
First Name & Middle Initial & Last Name & Degree
Enrique Reyes-Muñoz, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no applicable
Citations:
PubMed Identifier
27070643
Citation
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.
Results Reference
background
PubMed Identifier
27552564
Citation
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.
Results Reference
background

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Effect of Cocoa Polyphenols Supplementation on Cardiovascular Risk of Postmenopausal Women

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