Clinical Trials Directory

Trials / Completed

CompletedNCT01749020

Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
61 (actual)
Sponsor
Queen Margaret University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.

Detailed description

Polyphenols may have several favourable effects on health. Dark chocolate (DC) is one of the highest sources of polyphenols in foods. The aim of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults. Seventy four volunteers with no history of hypertension, cardiovascular diseases or diabetes will be recruited. Participants will randomly receive 20g daily of one of the two different types of DC: Placebo DC (low in polyphenols) or DC rich in polyphenols (500mg) for a period of four weeks. Participants will be asked to make two appointments to the university clinical lab. Anthropometric measurements (height, weight, waist circumference), blood and saliva samples will be taken during each of the 2 visits. Compliance will be tested by the measure of total polyphenols in a 24-hour urine sample in some random samples before and at the end of the intervention. To monitor any fluctuations in the participants' diet or physical activity during the study period, a three-day diet diary and a physical activity questionnaire will be collected before the start of the study and after four weeks. Data will be analysed with an ANCOVA with time (pre- and post-) and treatment (DC and placebo) as between-subject factor.

Conditions

Interventions

TypeNameDescription
OTHERPolyphenol-rich Dark chocolateParticipants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks
OTHERPlacebo Dark chocolateParticipants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 4 weeks

Timeline

Start date
2012-03-01
Primary completion
2013-07-01
Completion
2013-07-01
First posted
2012-12-13
Last updated
2013-11-20

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01749020. Inclusion in this directory is not an endorsement.