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
| Type | Name | Description |
|---|---|---|
| OTHER | Polyphenol-rich Dark chocolate | Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks |
| OTHER | Placebo Dark chocolate | Participants 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.