No Disease Clinical Trial
Official title:
Efficacy of Polyphenols From Milk and Dark Chocolate
| Verified date | July 2013 |
| Source | Nestlé |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised that the bioavailability and therefore probably the bioefficacy of epicatechin from milk chocolate was reduced compared to dark. This study is designed to compare milk and dark chocolate as a source of polyphenols with a control "chocolate" for improving a risk biomarker for vascular disease.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | April 2012 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 25 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - 25- 45 years, male and female - Healthy as determined by the medical questionnaire - Normal weight: BMI 19 - 25 - Having given informed consent Exclusion Criteria: - Intestinal or metabolic diseases/disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance. - Have had a major gastrointestinal surgery. - Have a regular consumption of medication. - Have an exceptionally high intake of chocolate or similarly high polyphenol foods. - Have a high and regular intake of vitamin supplements - Have an alcohol intake: > 2 units a day - Patient who cannot be expected to comply with treatment. - Smoker - Having a nut allergy - Unwilling to consume chocolate - Currently participating or having participated in another clinical trial during the last 3 weeks. - Having given blood in the past three weeks - More than 3 x 45 min of exercise per week |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Nestle Research Center | Lausanne | Vaud |
| Lead Sponsor | Collaborator |
|---|---|
| Nestlé |
Switzerland,
Fisher ND, Hollenberg NK. Aging and vascular responses to flavanol-rich cocoa. J Hypertens. 2006 Aug;24(8):1575-80. — View Citation
Heiss C, Finis D, Kleinbongard P, Hoffmann A, Rassaf T, Kelm M, Sies H. Sustained increase in flow-mediated dilation after daily intake of high-flavanol cocoa drink over 1 week. J Cardiovasc Pharmacol. 2007 Feb;49(2):74-80. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake | Value of RHI at 2 hours minus value at baseline. RHI reflects the endothelial function of a vessel at the distal phalanx of a finger, i.e. the capacity of the vessel to dilate after an ischemia. RHI is the increase of blood flow following the occlusion of the brachial artery during 5 minutes by the inflation of an armcuff. RHI was measured by peripheral arterial tonometry using a fingerprobe connected to an EndoPat analyser. | Baseline and 2 hours | No |
| Secondary | Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake | Value of arterial stiffness at 2 hours minus value at baseline. Arterial stiffness is also automatically calculated by peripheral arterial tonometry which consists in measuring the peripheral vessel endothelial response to an ischemia provoked by a 5-min occlusion of the humeral artery using an armcuff. An increase in arterial stiffness means an increase in the resistance of the vessel wall which reflects an impaired endothelial response to ischemia. |
baseline and 2 hours | No |