N/A
Completed N=5
Efficacy of Polyphenols From Milk and Dark Chocolate
No Disease
Source: ClinicalTrials.gov NCT00513344 ↗
Enrolled (actual)
5
Serious AEs
—
Results posted
Aug 2013
Primary outcomePrimary: Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake — 2.12; 2.30; 2.26 percentage of the pulse wave amplitude
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake |
2.12; 2.30; 2.26 | — |
| SECONDARY Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake |
-13.23; 1.23; -9.49 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00513344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.