Influence of Sugar on the Bioavailability of Cocoa Flavanols
The Influence of Maltitol on the Absorption and Metabolism of Flavanols From Chocolate
1 other identifier
interventional
15
1 country
1
Brief Summary
The primary propose of this study is to determine the impact of ingredients and matrices on flavanol absorption and metabolism.
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 Apr 2008
Shorter than P25 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
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedFebruary 10, 2011
December 1, 2010
2 months
February 9, 2011
February 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of ingredients and matrices on flavanol absorption and metabolism.
The absorption and metabolism of cocoa flavanols from a high-flavanol chocolate made with added sugar and a high-flavanol chocolate containing the sugar substitute maltitol will be assessed by using HPLC with fluorescence detection
4 hours
Study Arms (3)
Low flavanol
PLACEBO COMPARATORLow-flavanol chocolate contained 48 mg of cocoa flavanols. macro- and micro-nutrient matched with active comparator
High-flavanol with sugar
ACTIVE COMPARATORHigh-flavanol chocolate made with added sugar containing 251 mg of cocoa flavanols
High flavanol Maltitol
ACTIVE COMPARATORHigh-flavanol chocolate made with the sugar substitute maltitol containing 266 mg cocoa flavanols
Interventions
high-flavanol containing 251 mg cocoa flavanols
high-flavanol containing 266 mg cocoa flavanols
Eligibility Criteria
You may qualify if:
- a signed consent form
- age of 18-50 years inclusive
You may not qualify if:
- did not suffer from any form of disease, including liver disease, diabetes mellitus or a myocardial infarction
- not on medications for the treatment of hypertension, elevated lipids or diabetes (type I and II).
- did not suffered gall bladder problems or abnormalities of fat metabolism
- weight reducing dietary regimen or taking any dietary supplements, including dietary fatty acids
- did not consume more than 15 units (120g) of alcohol per week
- did not have sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten.
- Vegetarians and vegans
- taken antibiotics in the last 8 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Reading
Reading, Berkshire, RG6 6AP, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Spencer, PhD
University of Reading
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 10, 2011
Study Start
April 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
February 10, 2011
Record last verified: 2010-12