Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Polyphenol-rich Dark chocolate
Placebo Dark chocolate
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance focused on measuring Diabetes type II, Insulin sensitivity
Eligibility Criteria
Inclusion Criteria:
- Adults with no history of hypertension, diabetes and cardiovascular diseases
- BMI from 18-24.9 and BMI >25
- Males and Females
- Age: 18-65 years
Exclusion Criteria:
- Participants with cardiovascular diseases, hypertension or diabetes
- Smokers and heavy alcohol drinkers
- Participants taking any medications that affect insulin, cholesterol, triglycerides or blood pressure
- Participants taking dietary supplements containing high doses of antioxidants
- Postmenopausal women taking HRT (Hormone Replacement Therapy)
- Participants who recently participated or are currently on a weight management program
- Participants with regular consumption of cocoa or DC (> 1 serving/week)
Sites / Locations
- Queen Margaret University Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Polyphenol-rich Dark chocolate
Placebo Dark chocolate
Arm Description
Dark chocolate with 500 mg of polyphenols
This chocolate contains little or no polyphenols
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Determine if the consumption of DC rich in polyphenols can induce a change in glucose levels
Determine if the consumption of DC rich in polyphenols can induce a change in Lipid profile (TC, HDL, LDL & TG)
Determine if the consumption of DC rich in polyphenols can induce a change in oxidized LDL levels
Determine if the consumption of DC rich in polyphenols can induce a change in BMI and Waist circumference
Determine if the consumption of DC rich in polyphenols can induce a change in blood pressure
Determine if the consumption of DC rich in polyphenols can induce a change in salivary cortisol-to-cortisone ratio
Determine if the consumption of DC rich in polyphenols can induce a change in high sensitivity CRP
Full Information
NCT ID
NCT01749020
First Posted
December 10, 2012
Last Updated
November 19, 2013
Sponsor
Queen Margaret University
Collaborators
Barry Callebaut
1. Study Identification
Unique Protocol Identification Number
NCT01749020
Brief Title
Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults
Official Title
Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Margaret University
Collaborators
Barry Callebaut
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Diabetes type II, Insulin sensitivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyphenol-rich Dark chocolate
Arm Type
Experimental
Arm Description
Dark chocolate with 500 mg of polyphenols
Arm Title
Placebo Dark chocolate
Arm Type
Placebo Comparator
Arm Description
This chocolate contains little or no polyphenols
Intervention Type
Other
Intervention Name(s)
Polyphenol-rich Dark chocolate
Intervention Description
Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks
Intervention Type
Other
Intervention Name(s)
Placebo Dark chocolate
Intervention Description
Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 4 weeks
Primary Outcome Measure Information:
Title
Determine if the consumption of DC rich in polyphenols can induce a change in insulin sensitivity
Description
Insulin sensitivity will be determined by determined by HOMA-IR (Homeostasis Model of Assessment - Insulin Resistance)
Time Frame
Baseline and week 4
Secondary Outcome Measure Information:
Title
Determine if the consumption of DC rich in polyphenols can induce a change in glucose levels
Time Frame
Baseline and week 4
Title
Determine if the consumption of DC rich in polyphenols can induce a change in Lipid profile (TC, HDL, LDL & TG)
Time Frame
Baseline and week 4
Title
Determine if the consumption of DC rich in polyphenols can induce a change in oxidized LDL levels
Time Frame
Baseline and week 4
Title
Determine if the consumption of DC rich in polyphenols can induce a change in BMI and Waist circumference
Time Frame
Baseline and week 4
Title
Determine if the consumption of DC rich in polyphenols can induce a change in blood pressure
Time Frame
Baseline and week 4
Title
Determine if the consumption of DC rich in polyphenols can induce a change in salivary cortisol-to-cortisone ratio
Time Frame
Baseline and week 4
Title
Determine if the consumption of DC rich in polyphenols can induce a change in high sensitivity CRP
Time Frame
Baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults with no history of hypertension, diabetes and cardiovascular diseases
BMI from 18-24.9 and BMI >25
Males and Females
Age: 18-65 years
Exclusion Criteria:
Participants with cardiovascular diseases, hypertension or diabetes
Smokers and heavy alcohol drinkers
Participants taking any medications that affect insulin, cholesterol, triglycerides or blood pressure
Participants taking dietary supplements containing high doses of antioxidants
Postmenopausal women taking HRT (Hormone Replacement Therapy)
Participants who recently participated or are currently on a weight management program
Participants with regular consumption of cocoa or DC (> 1 serving/week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad Al-Dujaili, PhD
Organizational Affiliation
Queen Margaret University
Official's Role
Study Director
Facility Information:
Facility Name
Queen Margaret University Lab
City
Musselburgh
State/Province
East Lothian
ZIP/Postal Code
EH21 6UU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults
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