Postmenopausal WomenNCT03492983
Effect of High Cocoa Content Chocolate on Health in Postmenopausal Women.
A study testing Intervention group in people with Postmenopausal Women, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
This is a randomized clinical trial aimed at postmenopausal women aged 50 to 64 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of the additional intake of high cocoa content chocolate on blood pressure, vascular function, body composition, quality of… Read more about this study
- Who is it for?
- Ages 50 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to 31 Aug 2019
- 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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women in postmenopausal period defined as 12 consecutive months of amenorrhea.
Who cannot join
- Older than 65 years.
- Cardiovascular disease (acute myocardial infarction, stroke).
- Arterial hypertension on treatment.
- Diabetes mellitus.
- Dyslipidemia (total cholesterol >250 mg/dL or in lipid-lowering therapy).
- Clinically demonstrable neurological and/or neuropsychological disorders.
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- Hormone replacement therapy.
- Allergy and/or intolerance to cocoa or any of the components of the supplement.
- Hypocaloric diet.
- Any other circumstance that the investigators consider could interfere with the study procedures.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Biosanitario de Salamanca. Research unit La Alamedilla
Salamanca, 37003
About this study
Official title: Effect of High Cocoa Content Chocolate on Vascular Function, Body Composition, Health-related Quality of Life and Cognitive Performance in Postmenopausal Women.
This is a randomized clinical trial aimed at postmenopausal women aged 50 to 64 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of the additional intake of high cocoa content chocolate on blood pressure, vascular function, body composition, quality of life and cognitive performance.
Read the detailed description
- Objective: To assess the effect at 6 months of the additional intake of 10 g/day of high cocoa content chocolate for 6 months on blood pressure, vascular function, body composition, quality of life and cognitive performance in postmenopausal women.
- Design and setting: A randomized clinical trial of two parallel groups. Population: 140 postmenopausal women, 50 to 64 aged will be included, selected by consecutive sampling in two primary care centers.
- Measurements and intervention: Vascular function (blood pressure, augmentation index and Cardio-Ankle Vascular Index), body composition and health-related quality of life will be evaluated. The intervention group will receive a daily supplement of high cocoa content chocolate for 6 months.
- Conditions
- Postmenopausal Women
- Being tested
- Intervention group
- Keywords
- Cocoa, Vascular function, Body composition, Quality of life, Cognitive performance, Postmenopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupDietary supplement
10 g/day of high cocoa content chocolate for six months.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention |
| Intervention group | Experimental | Addition of 10 g/day of high cocoa content chocolate to the usual diet for six months Receives: Dietary Supplement: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measurement by oscillometric method (mmHg)
Measured: 6 months
Secondary outcomes (5)
Arterial stiffness
Measurement by Brachial-ankle pulse wave velocity (m/s)
Measured: 6 months
Wave reflection
Measurement by central and peripheral augmentation index
Measured: 6 months
Body composition
Measurement by body fat percentage
Measured: 6 months
Quality of life
Measurement by Cervantes Scale (Score between 0 (poor quality) and 155 (high quality)
Measured: 6 months
Cognitive performance
Measurement by executive function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Jun 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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 Postmenopausal 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service
- Responsible party
- Sponsor
- Investigators
- Jose I Recio-Rodriguez, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492983
- Sponsor's protocol ID
- GRS 1583/B/17
- Status last verified
- Feb 2020
- First submitted
- 23 Mar 2018
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Yu IA, Garcia-Ortiz L, Gomez-Marcos MA, Rodriguez-Sanchez E, Mora-Simon S, Maderuelo-Fernandez JA, Recio-Rodriguez JI. Effects of cocoa-rich chocolate on cognitive performance in postmenopausal women. A randomised clinical trial. Nutr Neurosci. 2022 Jun;25(6):1147-1158. doi: 10.1080/1028415X.2020.1840119. Epub 2020 Nov 15.
PubMed 33190575Garcia-Yu IA, Garcia-Ortiz L, Gomez-Marcos MA, Alonso-Dominguez R, Gonzalez-Sanchez J, Mora-Simon S, Gonzalez-Manzano S, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Recio-Rodriguez JI. Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial. BMJ Open. 2018 Dec 14;8(12):e024095. doi: 10.1136/bmjopen-2018-024095.
PubMed 30552275
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Cocoa Content Chocolate on Vascular Function, Body Composition, Health-related Quality of Life and Cognitive Performance in Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT03492983
- Acronym / sponsor ID
- GRS 1583/B/17
- Conditions
- Postmenopausal Women
- Keywords
- Cocoa, Vascular function, Body composition, Quality of life, Cognitive performance, Postmenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Castilla-León Health Service
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 10 Apr 2018 (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.
This is a randomized clinical trial aimed at postmenopausal women aged 50 to 64 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of the additional intake of high cocoa content chocolate on blood pressure, vascular function, body composition, quality of life and cognitive performance.
Detailed description
- Objective: To assess the effect at 6 months of the additional intake of 10 g/day of high cocoa content chocolate for 6 months on blood pressure, vascular function, body composition, quality of life and cognitive performance in postmenopausal women.
- Design and setting: A randomized clinical trial of two parallel groups. Population: 140 postmenopausal women, 50 to 64 aged will be included, selected by consecutive sampling in two primary care centers.
- Measurements and intervention: Vascular function (blood pressure, augmentation index and Cardio-Ankle Vascular Index), body composition and health-related quality of life will be evaluated. The intervention group will receive a daily supplement of high cocoa content chocolate for 6 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention |
| Intervention group | Experimental | Dietary Supplement: Intervention groupAddition of 10 g/day of high cocoa content chocolate to the usual diet for six months |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women in postmenopausal period defined as 12 consecutive months of amenorrhea.
Key exclusion criteria (10 listed)
- Older than 65 years.
- Cardiovascular disease (acute myocardial infarction, stroke).
- Arterial hypertension on treatment.
- Diabetes mellitus.
- Dyslipidemia (total cholesterol >250 mg/dL or in lipid-lowering therapy).
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 |
|---|---|---|
| Intervention group10 g/day of high cocoa content chocolate for six months. | Dietary supplement | Intervention group |
Primary outcome
Blood pressure
Time frame: 6 months
Measurement by oscillometric method (mmHg)
5 secondary outcomes
Arterial stiffness
Time frame: 6 months
Wave reflection
Time frame: 6 months
Body composition
Time frame: 6 months
Quality of life
Time frame: 6 months
Cognitive performance
Time frame: 6 months
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 Feb 2020.
- Derived from this study: PubMed 33190575Garcia-Yu IA, Garcia-Ortiz L, Gomez-Marcos MA, Rodriguez-Sanchez E, Mora-Simon S, Maderuelo-Fernandez JA, Recio-Rodriguez JI. Effects of cocoa-rich chocolate on cognitive performance in postmenopausal women. A randomised clinical trial. Nutr Neurosci. 2022 Jun;25(6):1147-1158. doi: 10.1080/1028415X.2020.1840119. Epub 2020 Nov 15.
- Derived from this study: PubMed 30552275Garcia-Yu IA, Garcia-Ortiz L, Gomez-Marcos MA, Alonso-Dominguez R, Gonzalez-Sanchez J, Mora-Simon S, Gonzalez-Manzano S, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Recio-Rodriguez JI. Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial. BMJ Open. 2018 Dec 14;8(12):e024095. doi: 10.1136/bmjopen-2018-024095.
- 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.
Jose I Recio-Rodriguez, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Postmenopausal Women, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud 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 1 inclusion and 10 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 Feb 2020. 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?
Blood pressure (time frame: 6 months). 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 NCT03492983, 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 21 Feb 2020.