Post-menopausal WomenCARDIOGENENCT05255367
Effect of (Poly)Phenolic on Cardiometabolic Risk of Postmenopausal Women
A study testing (poly)phenols rich foods in people with Post-menopausal Women and Overweight and Obesity, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The purpose of this investigation is to test the hypothesis that in post-menopausal women with cardiometabolic risk, eating a relatively high daily amount of (poly)phenol-containing products (green tea, dark chocolate and berries) could reduce the risk of metabolic syndrome and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Post-menopausal Women, Overweight and Obesity
- What is being tested?
- (poly)phenols rich foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 1 Jul 2022
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 45-65 years old
- With 12 months of amenorrhea
- With overweight or obesity (BMI 25-32) or high percentage of body fat or waist to hip ratio >0.85.
- Total cholesterol lower than 240 mg/dL
Who cannot join
- Pre-menopausal women
- Hormonal therapy and other pharmacological treatment
- Less than 12 months of amenorrhea
- Smoking women
- Endocrine (Diabetes mellitus or others), renal, hepatic, cancer or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Consumption of (Poly)Phenolic Rich Products on Cardiometabolic Risk Markers in Postmenopausal Women
The purpose of this investigation is to test the hypothesis that in post-menopausal women with cardiometabolic risk, eating a relatively high daily amount of (poly)phenol-containing products (green tea, dark chocolate and berries) could reduce the risk of metabolic syndrome and cardiovascular disease. Changes in different biomarkers of lipid metabolism, glucose metabolism, inflammation and oxidative stress will be evaluated. Other related factors may be also affected, such as body mass index (BMI) and the percentage of body fat, dietary habits (total energy intake and macronutrient distribution) and microbiota composition.
Read the detailed description
Menopause is a stage characterized by the sudden decrease in estrogens linked to the absence of amenorrhea for at least 12 months. Estrogens are involved in certain metabolic pathways such as lipids metabolism and the distribution of body fat in the body. As a result of the fall of estrogen production, postmenopausal women experience a number of alterations of the energy homeostasis that are accompanied by an increase in body weight and a tendency to obesity and visceral fat deposition, as well as variations in the levels of total cholesterol (T-C), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TGs), increasing the risk for cardiometabolic diseases. In addition, menopause contributes to disorders of the glucose metabolism increasing insulin resistance (IR) that can predispose to the development of type 2 diabetes mellitus (T2DM).
(Poly)phenols are recognized as bioactive compounds with general antioxidant and anti-inflammatory activity and as potent vasodilators and stimulators of the immune response with the capacity to modulate a range of cardiovascular and metabolic risk factors. An increasing number of intervention studies have built up the evidence of the cardiovascular and metabolic benefits of the intake of these compounds in humans, however, the results remain limited and contradictory, leading to the current controversy regarding the consistency and magnitude of the protective effects that these compounds exert in humans. The lack of consistent and significant results may be partially due to the heterogeneity of the studies and the interindividual variability of the participants.
The investigators have designed this intervention to clearly described the effects of the (poly)phenolic compounds in postmenopausal women with a well-characterized cardiometabolic status. The observed beneficial effects will be correlated with the absorption and metabolism of these compounds.
The protocol will be a single arm intervention study with 22 postmenopausal women as a participants. Prior to start the intervention (initial time of the study) the volunteers will follow their habitual diet during 30 days as a control period. Immediately, they will start with the intervention period (baseline) following their habitual diet supplemented with (poly)phenol rich products, eating daily 100 ml of a commercial juice of berries and pomegranate, 20 g dark chocolate and 1 green tea, during 60 days (after intervention).
At the beginning of the study (initial time), at the beginning of the intervention (baseline) and at the end of the intervention (after the intervention) with rich (poly)phenols foods, biological samples (blood, urine and feces) and anthropometric measurements will be taken. In addition, the participants will record the food intake weekly with a 24 h dietary-recall form.
The investigators will evaluate followed parameters: 1) glucose metabolism indicators, i.e. glucose, insulin and Homeostatic Model Assessment of IR (HOMA-IR), 2) lipid profile (T-C, LDL-C, HDL-C and TGs), 3) blood pressure, both, systolic blood pressure (SBP), and diastolic blood pressure (DBP), 4) biomarkers of inflammation, CRP, TNF-α, adiponectin, soluble vascular cell adhesion molecule 1 (sVCAM-1), soluble intercellular adhesion molecule 1 (sICAM-1), 5) biomarkers of oxidative stress: oxidized isoprostanes and malonaldehyde (MDA), 6) body mass index, body fat and waist-to-hip ratio, 7) dietary habits (total energy intake and macronutrient distribution), 8) metabolites and catabolites of (poly)phenols, and 9) changes in the microbiota.
- Conditions
- Post-menopausal Women, Overweight and Obesity
- Being tested
- (poly)phenols rich foods
- Keywords
- Menopause, (Poly)phenols, Cardiometabolic risk, Oxidative stress, Lipid and glucose metabolism
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(poly)phenols rich foodsCombination product
Prior to start the intervention (initial time of the study) the volunteers will follow their habitual diet during 30 days as a control period, and then they will start with the intervention period (baseline) following their habitual diet supplemented with (poly)phenol rich products during 60 days (after intervention).
At the beginning of the study (initial time), at the beginning of the intervention (baseline) and at the end of the intervention (after the intervention) with rich (poly)phenols foods, biological samples (blood, urine and feces) and anthropometric measurements will be taken. In addition, the participants will record the food intake weekly with a 24 h dietary-recall form.
| Study group | Role | What they receive |
|---|---|---|
| Intake of (poly)phenol rich foods | Experimental | Daily consumption of 100 ml of a commercial juice of berries and pomegranate, 20 g dark chocolate and 1 green tea, to test if the supplementation of the diet with (poly)phenol rich foods, during 2 months, reduce the cardiometabolic risk in post-post-menopausal women. Receives: Combination Product: (poly)phenols rich foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum levels of glucose and insulin.
The investigators will measure the changes in levels of glucose and insulin. samples
Measured: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Changes in plasmatic lipid profile.
the investigators will measure the changes in levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and total triglycerides.
Measured: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Changes in blood pressure.
Both, systolic blood pressure (SBP), and diastolic blood pressure (DBP) will be measure.
Measured: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Changes in biomarkers of inflammation in plasma.
The investigators will measure the CRP, the TNF-α, the adiponectin, the soluble vascular cell adhesion molecule 1 (sVCAM-1) and the soluble intercellular adhesion molecule 1 (sICAM-1).
Measured: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Changes in biomarkers of oxidative stress in urine.
The investigators will measure the level of isoprostanes and malonaldehyde. (MDA)
Measured: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Secondary outcomes (4)
Changes in body mass index.
The investigators will measure the body mass index (Kg/m^2).
Measured: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Changes in body composition.
The investigators will measure the percentage of the body fat mass, body lean mass, total body water and body bone mass using a Tanita DC-430-MA analyzer.
Measured: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Changes hip-to-waist ratio.
The investigators will measure the hip-to-waist ratio.
Measured: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Dietary habits (total energy intake and macronutrient distribution).
The diet will be registered during interventions periods. Volunteers registered the intake of food during 24 h (2 days/week) to determine the adherence to the Mediterranean diet and quantify the intake of energy and macronutrients distribution.
Measured: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-menopausal WomenStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Jesús Periago, Universidad de Murcia
- Investigators
- Maria J Periago Castón, Full Prof., Study director, Universidad de MurciaRocio González Barrio, Assis. Prof., Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255367
- Sponsor's protocol ID
- (Poly)phenol and menopause
- Other IDs
- 20904/PI/2018
- Acronym
- CARDIOGENE
- Status last verified
- Jul 2022
- First submitted
- 10 Jan 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Consumption of (Poly)Phenolic Rich Products on Cardiometabolic Risk Markers in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05255367
- Acronym / sponsor ID
- CARDIOGENE / (Poly)phenol and menopause
- Conditions
- Post-menopausal Women, Overweight and Obesity
- Keywords
- Menopause, (Poly)phenols, Cardiometabolic risk, Oxidative stress, Lipid and glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 24 Feb 2022 (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.
The purpose of this investigation is to test the hypothesis that in post-menopausal women with cardiometabolic risk, eating a relatively high daily amount of (poly)phenol-containing products (green tea, dark chocolate and berries) could reduce the risk of metabolic syndrome and cardiovascular disease. Changes in different biomarkers of lipid metabolism, glucose metabolism, inflammation and oxidative stress will be evaluated. Other related factors may be also affected, such as body mass index (BMI) and the percentage of body fat, dietary habits (total energy intake and macronutrient distribution) and microbiota composition.
Detailed description
Menopause is a stage characterized by the sudden decrease in estrogens linked to the absence of amenorrhea for at least 12 months. Estrogens are involved in certain metabolic pathways such as lipids metabolism and the distribution of body fat in the body. As a result of the fall of estrogen production, postmenopausal women experience a number of alterations of the energy homeostasis that are accompanied by an increase in body weight and a tendency to obesity and visceral fat deposition, as well as variations in the levels of total cholesterol (T-C), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) and triglycerides (TGs), increasing the risk for cardiometabolic diseases. In addition, menopause contributes to disorders of the glucose metabolism increasing insulin resistance (IR) that can predispose to the development of type 2 diabetes mellitus (T2DM).
(Poly)phenols are recognized as bioactive compounds with general antioxidant and anti-inflammatory activity and as potent vasodilators and stimulators of the immune response with the capacity to modulate a range of cardiovascular and metabolic risk factors. An increasing number of intervention studies have built up the evidence of the cardiovascular and metabolic benefits of the intake of these compounds in humans, however, the results remain limited and contradictory, leading to the current controversy regarding the consistency and magnitude of the protective effects that these compounds exert in humans. The lack of consistent and significant results may be partially due to the heterogeneity of the studies and the interindividual variability of the participants.
The investigators have designed this intervention to clearly described the effects of the (poly)phenolic compounds in postmenopausal women with a well-characterized cardiometabolic status. The observed beneficial effects will be correlated with the absorption and metabolism of these compounds.
The protocol will be a single arm intervention study with 22 postmenopausal women as a participants. Prior to start the intervention (initial time of the study) the volunteers will follow their habitual diet during 30 days as a control period. Immediately, they will start with the intervention period (baseline) following their habitual diet supplemented with (poly)phenol rich products, eating daily 100 ml of a commercial juice of berries and pomegranate, 20 g dark chocolate and 1 green tea, during 60 days (after intervention).
At the beginning of the study (initial time), at the beginning of the intervention (baseline) and at the end of the intervention (after the intervention) with rich (poly)phenols foods, biological samples (blood, urine and feces) and anthropometric measurements will be taken. In addition, the participants will record the food intake weekly with a 24 h dietary-recall form.
The investigators will evaluate followed parameters: 1) glucose metabolism indicators, i.e. glucose, insulin and Homeostatic Model Assessment of IR (HOMA-IR), 2) lipid profile (T-C, LDL-C, HDL-C and TGs), 3) blood pressure, both, systolic blood pressure (SBP), and diastolic blood pressure (DBP), 4) biomarkers of inflammation, CRP, TNF-α, adiponectin, soluble vascular cell adhesion molecule 1 (sVCAM-1), soluble intercellular adhesion molecule 1 (sICAM-1), 5) biomarkers of oxidative stress: oxidized isoprostanes and malonaldehyde (MDA), 6) body mass index, body fat and waist-to-hip ratio, 7) dietary habits (total energy intake and macronutrient distribution), 8) metabolites and catabolites of (poly)phenols, and 9) changes in the microbiota.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group
| Arm | Type | Receives |
|---|---|---|
| Intake of (poly)phenol rich foods | Experimental | Combination Product: (poly)phenols rich foodsDaily consumption of 100 ml of a commercial juice of berries and pomegranate, 20 g dark chocolate and 1 green tea, to test if the supplementation of the diet with (poly)phenol rich foods, during 2 months, reduce the cardiometabolic risk in post-post-menopausal women. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women 45-65 years old
- With 12 months of amenorrhea
- With overweight or obesity (BMI 25-32) or high percentage of body fat or waist to hip ratio >0.85.
- Total cholesterol lower than 240 mg/dL
Key exclusion criteria (5 listed)
- Pre-menopausal women
- Hormonal therapy and other pharmacological treatment
- Less than 12 months of amenorrhea
- Smoking women
- Endocrine (Diabetes mellitus or others), renal, hepatic, cancer or psychiatric disorders
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 |
|---|---|---|
| (poly)phenols rich foodsPrior to start the intervention (initial time of the study) the volunteers will follow their habitual diet during 30 days as a control period, and then they will start with the intervention period (baseline) following their habitual diet supplemented with (poly)phenol rich products during 60 days (after intervention). At the beginning of the study (initial time), at the beginning of the intervention (baseline) and at the end of the intervention (after the intervention) with rich (poly)phenols foods, biological samples (blood, urine and feces) and anthropometric measurements will be taken. In addition, the participants will record the food intake weekly with a 24 h dietary-recall form. | Combination product | Intake of (poly)phenol rich foods |
Primary outcome
Changes in serum levels of glucose and insulin.
Time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
The investigators will measure the changes in levels of glucose and insulin. samples
Changes in plasmatic lipid profile.
Time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
the investigators will measure the changes in levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and total triglycerides.
Changes in blood pressure.
Time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Both, systolic blood pressure (SBP), and diastolic blood pressure (DBP) will be measure.
Changes in biomarkers of inflammation in plasma.
Time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
The investigators will measure the CRP, the TNF-α, the adiponectin, the soluble vascular cell adhesion molecule 1 (sVCAM-1) and the soluble intercellular adhesion molecule 1 (sICAM-1).
Changes in biomarkers of oxidative stress in urine.
Time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
The investigators will measure the level of isoprostanes and malonaldehyde. (MDA)
4 secondary outcomes
Changes in body mass index.
Time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Changes in body composition.
Time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Changes hip-to-waist ratio.
Time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Dietary habits (total energy intake and macronutrient distribution).
Time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Maria J Periago Castón, Full Prof. study director
Universidad de Murcia
Rocio González Barrio, Assis. Prof. principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (poly)phenols rich foods in people with Post-menopausal Women and Overweight and Obesity, run by Universidad de Murcia at 1 site in Spain.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jul 2022. 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 Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum levels of glucose and insulin. (time frame: At initial time of the study, at baseline (the beginning of the intervention) and after 60 days of intake rich (poly)phenols foods (after the intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2022.