Metabolic SyndromeNCT05158673
Effect of Cocoa Polyphenols Supplementation on Cardiovascular Risk of Postmenopausal Women
A study testing Cocoa flavonoids in people with Metabolic Syndrome, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Cocoa flavonoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jan 2022to 1 Jul 2023
- 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
- -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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Mexico City, 11000
Araceli Montoya-Estrada, PhD, +52 5555209900 ext. 307, ara_mones@hotmail.com
Guillermo Ceballos, PhD
About this study
Official title: Effect of Cocoa Polyphenols Supplementation on Cardiovascular Risk of Overweight or Obese Postmenopausal Women: Double Blind Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Placebo of Cocoa flavonoids, Cocoa flavonoids
- Keywords
- flavonoids, cocoa, postmenopausal women, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo of Cocoa flavonoidsDietary 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
Cocoa flavonoidsDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Cocoa flavonoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Metabolic Syndrome
Metabolic syndrome according to International Diabetes Federation Criteria
Measured: Metabolic Syndrome at three months after starting the intervention in each group
Secondary outcomes (6)
Carbonylation of proteins
Marker of oxidative stress measured by spectrophotometry expressed as pmol PC/mg protein
Measured: Three months after starting the intervention in each group
Malondialdehyde
Marker of oxidative stress measured by spectrophotometry expressed as pmol MDA/mg dry weight
Measured: Three months after starting the intervention in each group
Superoxide Dismutase activity
Enzymatic activity measured by Colorimetric Activity Kit expressed as nmol/min/mL
Measured: Three months after starting the intervention in each group
Catalase activity
Enzymatic activity measured by Colorimetric Activity Kit expressed as nmol/min/mL
Measured: Three months after starting the intervention in each group
Lipid profile quantification
size of cholesterol (main classes and subclasses of lipoproteins) expressed in large, medium and small)
Measured: Three months after starting the intervention in each group
IL-4, IL-6, IL10 and TNFa
They will be quantified by ELISA technique expressed in pg/ul
Measured: Three months after starting the intervention in each group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start15 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Collaborators
- National Polytechnic Institute, Mexico
- Responsible party
- Principal investigator, Araceli Montoya-Estrada, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Investigators
- Araceli Montoya-Estrada, PhD, Principal investigator, Instituto Nacional de Perinatología Isidro Espinosa de los ReyesNayelli Najera, PhD, Study director, Instituto Politecnico Nacional
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158673
- Sponsor's protocol ID
- 2020-1-29
- Status last verified
- Dec 2021
- First submitted
- 17 Nov 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no applicable
Publications
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.
PubMed 27070643Gutierrez-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.
PubMed 27552564
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cocoa Polyphenols Supplementation on Cardiovascular Risk of Overweight or Obese Postmenopausal Women: Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05158673
- Acronym / sponsor ID
- 2020-1-29
- Conditions
- Metabolic Syndrome
- Keywords
- flavonoids, cocoa, postmenopausal women, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Collaborators
- National Polytechnic Institute, Mexico
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 15 Dec 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Group A (Placebo) | Placebo comparator | Dietary Supplement: Placebo of Cocoa flavonoidsThe administration of two capsules of 500 mg orally of placebo (excipient q.s. starch capsule) 1 every 12 hours, for 12 weeks. |
| Group B (Flavonoid) | Active comparator | Dietary Supplement: Cocoa flavonoidsTwo capsules of 500 mg of the flavonoid supplement (whose total flavonoid content is 15 mg/capsule) orally every 12 hours for 12 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- -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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Placebo of Cocoa flavonoidsDietary supplement: 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 | Group A (Placebo) |
| Cocoa flavonoidsDietary 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 | Dietary supplement | Group B (Flavonoid) |
Primary outcome
Number of participants with Metabolic Syndrome
Time frame: Metabolic Syndrome at three months after starting the intervention in each group
Metabolic syndrome according to International Diabetes Federation Criteria
6 secondary outcomes
Carbonylation of proteins
Time frame: Three months after starting the intervention in each group
Malondialdehyde
Time frame: Three months after starting the intervention in each group
Superoxide Dismutase activity
Time frame: Three months after starting the intervention in each group
Catalase activity
Time frame: Three months after starting the intervention in each group
Lipid profile quantification
Time frame: Three months after starting the intervention in each group
IL-4, IL-6, IL10 and TNFa
Time frame: Three months after starting the intervention in each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Background: PubMed 27070643Goya 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.
- Background: PubMed 27552564Gutierrez-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.
- Individual participant dataSharing planned: No. no applicable
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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
Nayelli Najera, PhD study director
Instituto Politecnico Nacional
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa flavonoids in people with Metabolic Syndrome, 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 10 inclusion and 4 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 15 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?
Contact Araceli Montoya-Estrada, PhD (525555209900 ext. 307, ara_mones@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Metabolic Syndrome (time frame: Metabolic Syndrome at three 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?
On the ClinicalTrials.gov record for NCT05158673, which also lists 2 linked publications.
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 15 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.