Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Barry Callebaut | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyphenol-rich Dark chocolate | Experimental | Dark chocolate with 500 mg of polyphenols |
|
| Placebo Dark chocolate | Placebo Comparator | This chocolate contains little or no polyphenols |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyphenol-rich Dark chocolate | Other | Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine if the consumption of DC rich in polyphenols can induce a change in insulin sensitivity | Insulin sensitivity will be determined by determined by HOMA-IR (Homeostasis Model of Assessment - Insulin Resistance) | Baseline and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if the consumption of DC rich in polyphenols can induce a change in glucose levels | Baseline and week 4 | |
| Determine if the consumption of DC rich in polyphenols can induce a change in Lipid profile (TC, HDL, LDL & TG) | Baseline and week 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emad Al-Dujaili, PhD | Queen Margaret University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Margaret University Lab | Musselburgh | East Lothian | EH21 6UU | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Dark chocolate | Other | Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 4 weeks |
|
| Determine if the consumption of DC rich in polyphenols can induce a change in oxidized LDL levels | Baseline and week 4 |
| Determine if the consumption of DC rich in polyphenols can induce a change in BMI and Waist circumference | Baseline and week 4 |
| Determine if the consumption of DC rich in polyphenols can induce a change in blood pressure | Baseline and week 4 |
| Determine if the consumption of DC rich in polyphenols can induce a change in salivary cortisol-to-cortisone ratio | Baseline and week 4 |
| Determine if the consumption of DC rich in polyphenols can induce a change in high sensitivity CRP | Baseline and Week 4 |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |