Polyphenol Bioavailability From Chocolate
Comparison of the Bioavailability of Polyphenols From Milk and Dark Chocolate
1 other identifier
interventional
18
1 country
1
Brief Summary
Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised that the bioavailability of epicatechin from milk chocolate was reduced compared to dark. The primary outcome measure is to compare plasma polyphenol levels after consumption of 3 chocolates (2 milk, 1 dark) while the secondary outcome measures are to characterise the time course of polyphenols in the blood and to investigate individual variation in Tmax and Cmax for use in future studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jun 2007
Longer than P75 for not_applicable healthy
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
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMarch 29, 2013
March 1, 2013
1.3 years
June 25, 2007
March 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUC plasma polyphenols
24 hours
Secondary Outcomes (2)
Tmax and Cmax of plasma polyphenols
24 hours
Plasma and urinary metabolite identification and quantification
24 hours
Study Arms (3)
1
ACTIVE COMPARATORDark chocolate
2
ACTIVE COMPARATORMilk chocolate 1
3
ACTIVE COMPARATORMilk chocolate 2
Interventions
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 (1)
Serafini M, Bugianesi R, Maiani G, Valtuena S, De Santis S, Crozier A. Plasma antioxidants from chocolate. Nature. 2003 Aug 28;424(6952):1013. doi: 10.1038/4241013a. No abstract available.
PMID: 12944955BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Karen A Cooper, PhD
Société des Produits Nestlé (SPN)
- STUDY DIRECTOR
Gary Williamson, PhD
Société des Produits Nestlé (SPN)
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
June 25, 2007
First Posted
June 27, 2007
Study Start
June 1, 2007
Primary Completion
September 1, 2008
Study Completion
April 1, 2012
Last Updated
March 29, 2013
Record last verified: 2013-03