Efficacy of Polyphenols From Milk and Dark Chocolate
1 other identifier
interventional
6
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2007
CompletedFirst Posted
Study publicly available on registry
August 8, 2007
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
August 14, 2013
CompletedAugust 14, 2013
July 1, 2013
1 year
August 6, 2007
March 28, 2013
July 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake
baseline and 2 hours
Study Arms (3)
dark chocolate containing polyphenols
EXPERIMENTALdark chocolate
Milk chocolate containing polyphenols
EXPERIMENTALBespoke milk chocolate
Control chocolate with no polyphenols
ACTIVE COMPARATORcocoa-free chocolate
Interventions
one portion
Eligibility Criteria
You may qualify if:
- years, male and female
- Healthy as determined by the medical questionnaire
- Normal weight: BMI 19 - 25
- Having given informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nestle Research Center
Lausanne, Canton of Vaud, 1000, Switzerland
Related Publications (2)
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. doi: 10.1097/FJC.0b013e31802d0001.
PMID: 17312446BACKGROUNDFisher ND, Hollenberg NK. Aging and vascular responses to flavanol-rich cocoa. J Hypertens. 2006 Aug;24(8):1575-80. doi: 10.1097/01.hjh.0000239293.40507.2a.
PMID: 16877960BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Maurice Beaumont, Principal Investigator
- Organization
- Clinical Development Unit / Metabolic Unit
Study Officials
- PRINCIPAL INVESTIGATOR
Karen A Cooper, PhD
Société des Produits Nestlé (SPN)
- STUDY DIRECTOR
Gary Williamson, PhD
Société des Produits Nestlé (SPN)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2007
First Posted
August 8, 2007
Study Start
June 1, 2008
Primary Completion
June 1, 2009
Study Completion
April 1, 2012
Last Updated
August 14, 2013
Results First Posted
August 14, 2013
Record last verified: 2013-07