Effects of chronic consumption of cocoa flavonoids on vascular function
| ISRCTN | ISRCTN32888088 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32888088 |
| Secondary identifying numbers | 05/06-158 |
- Submission date
- 26/07/2013
- Registration date
- 23/08/2013
- Last edited
- 24/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
This is a study to investigate the effects of long-term cocoa intake on the cardiovascular health of post-menopausal women as they are known to be at greater risk of cardiovascular disease. Our goal is to investigate if drinking cocoa high in antioxidant compounds called flavonoids will improve your cardiovascular health.
Who can participate?
Post-menopausal women aged between 49 and 65 years.
What does the study involve?
Initially we will ask you questions about your medical history, measure your weight, height, blood pressure, waist and hip circumference. We take a small blood sample to ascertain that your blood chemistry is normal. Providing the blood tests are normal you will then be invited to take part in the study and attend the hospital on a total of four occasions - at the beginning and end of each 6-week period. You will be required to give blood and urine samples and have your arteries scanned at the beginning and end of each 6-week period. You will be randomly allocated to receive either specially made cocoa powder or a dummy (placebo) cocoa powder dissolved in water daily for 6 weeks. There will then be a 4-week break where you do not have to consume any cocoa. After this, you will receive the other cocoa powder to drink daily for 6 weeks.
What are the possible benefits and risks of participating?
There could be benefits from drinking the high antioxidant cocoa. There is a small risk of bruising from giving a blood sample. The scan of the arteries requires placing a tablet (glyceryl trinitrite) under your tongue for 5 minutes before the scan and this may cause some tingling, discomfort or pain.
Where is the study run from?
The study is run from King's College London in collaboration with St Thomas Hospital (UK).
When is the study starting and how long is it expected to run for?
August 2006 to February 2007
Who is funding the study?
King's College London (UK) and the cocoa was manufactured and supplied by Mars Inc
Who is the main contact?
Dr Ummezeinab Mulla
zeinab.mulla@imperial.ac.uk
Professor Thomas Sanders
tom.sanders@kcl.ac.uk
Contact information
Scientific
150 Stamford Street
Franklin Wilkins Building
King's College London
Waterloo
London
SE1 9NH
United Kingdom
| Phone | +44 (0)20 7848 4273 |
|---|---|
| tom.sanders@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An investigation into the effects of chronic consumption of cocoa flavonoids on vascular function: a randomised controlled trial |
| Study hypothesis | Cocoa flavonoids lower blood pressure and improve endothelial function. |
| Ethics approval(s) | King's College London Research Ethics Committee, 04/08/2006 |
| Condition | Cardiovascular disease |
| Intervention | Subjects were supplied with packets of cocoa powder. They were instructed to take two packets daily for two 6 week periods (dissolved in water) with a break inbetween (minimum of 4 weeks break). Each pack contained 20g of cocoa. The placebo product contained 16 mg of flavonols per packet and the flavonol rich product contained approximately 330 mg of flavonols per packet. Subjects consumed twice this amount per day as they had two packets per day. There was no follow up once they had finished the study (the two 6 week interventions). |
| Intervention type | Other |
| Primary outcome measure | Blood pressure The outcome measures were taken at the beginning and end of each intervention period. |
| Secondary outcome measures | Arterial stiffness, flow mediated dilatation, plasma ICAM-1, VCAM-1, C-reactive protein, P-selectin, 8-isoprostane F2 α, lipids and urinary 8-isoprostane F2 |
| Overall study start date | 24/08/2006 |
| Overall study end date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 16 |
| Participant inclusion criteria | Non-smoking postmenopausal women aged between 48 and 65 years |
| Participant exclusion criteria | 1. Current smokers were excluded due to confounding influences of smoking on measurement of endothelial function 2. A reported history of myocardial infarction, angina, venous thrombosis, stroke, diabetes (fasting plasma glucose > 7mmol/L) or invasive cancer in the last five years 3. Recent use of oral hypolipidaemic therapy (in the last three months) 4. Current use of antihypertensive medication 5. Those receiving drugs for regulating haemostasis but excluding aspirin or who have been exposed to any investigational agent within 30 days of the study 6. Presence of gastrointestinal disorder or use of a drug, which is likely to alter gastrointestinal motility or nutrient absorption 7. Alcohol intake exceeding a moderate intake (>28 units per week) 8. Body Mass Index between <20 or >35 kg/m2 9. Blood pressure systolic >160mm Hg or diastolic >100 mm Hg 10. Fasting blood cholesterol >7.8 mmol/l 11. Fasting plasma triacyglycerol concentrations > 3 mmol/l 12. Estimated cardiovascular risk of greater than 20% over the next 10 years using the Framingham algorithm 13. Subjects unable to tolerate chocolate products 14. Dietary supplements other than vitamin and mineral supplement or fish oil (not exceeding 0.45g long chain n-3 fatty acids/d) |
| Recruitment start date | 24/08/2006 |
| Recruitment end date | 28/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 9NH
United Kingdom
Sponsor information
University/education
c/o Professor Tom Sanders
150 Stamford Street
Franklin Wilkins Building
Waterloo
London
SE1 9NH
England
United Kingdom
| Phone | +44 (0)20 7848 4273 |
|---|---|
| tom.sanders@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Collegium Regale Londiniense, King's, KCL
- Location
- United Kingdom
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Mars Incorporated, Mars, Incorporated
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/10/2019: No publications found. Verifying results with principal investigator
08/08/2016: No publications found in PubMed, verifying study status with principal investigator.
