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Clinical Trials/NCT01292967
NCT01292967CompletedNot Applicable

The Influence of Maltitol on the Absorption and Metabolism of Flavanols From Chocolate

University of Reading1 site in 1 country15 target enrollmentStarted: April 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Impact of ingredients and matrices on flavanol absorption and metabolism.

Study Overview

Brief Summary

The primary propose of this study is to determine the impact of ingredients and matrices on flavanol absorption and metabolism.

Detailed Description

The investigators have conducted a randomized, triple-blind, cross-over study in 15 healthy human volunteers to investigate 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; a nutrient-matched low flavanol control product was also fed. All products were matched for macro-nutrients, as well as for alkaloids (theobromine and caffeine), and were similar in taste and appearance. Both high-flavanol products contained ~259 mg cocoa flavanols, whilst the low-flavanol chocolate contained 48 mg of cocoa flavanols. On each study day, subjects were cannulated and baseline blood samples were collected prior to consumption of any of the test chocolates. Additional blood samples were collected at 1, 2 and 4 hours and plasma levels of flavanols were assessed using HPLC with fluorescence detection. All test products were well-tolerated by study participants.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •a signed consent form
  • •age of 18-50 years inclusive

Exclusion Criteria

  • •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

Arms & Interventions

Low flavanol

Placebo Comparator

Low-flavanol chocolate contained 48 mg of cocoa flavanols. macro- and micro-nutrient matched with active comparator

Intervention: Low flavanol chocolate (Dietary Supplement)

High-flavanol with sugar

Active Comparator

High-flavanol chocolate made with added sugar containing 251 mg of cocoa flavanols

Intervention: High-flavanol with sugar (Dietary Supplement)

High flavanol Maltitol

Active Comparator

High-flavanol chocolate made with the sugar substitute maltitol containing 266 mg cocoa flavanols

Intervention: High flavanol Maltitol (Dietary Supplement)

Outcomes

Primary Outcomes

Impact of ingredients and matrices on flavanol absorption and metabolism.

Time Frame: 4 hours

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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