Insulin ResistanceNCT01749020
Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults
A study testing Polyphenol-rich Dark chocolate in people with Insulin Resistance, run by Queen Margaret University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Polyphenol-rich Dark chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Margaret University Lab
Musselburgh, East Lothian, EH21 6UU
About this study
The purpose of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.
Read the 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
- Insulin Resistance
- Being tested
- Polyphenol-rich Dark chocolate, Placebo Dark chocolate
- Keywords
- Diabetes type II, Insulin sensitivity
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol-rich Dark chocolateOther
Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks
Placebo Dark chocolateOther
Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Polyphenol-rich Dark chocolate | Experimental | Dark chocolate with 500 mg of polyphenols Receives: Other: Polyphenol-rich Dark chocolate |
| Placebo Dark chocolate | Placebo comparator | This chocolate contains little or no polyphenols Receives: Other: Placebo Dark chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and week 4
Secondary outcomes (7)
Determine if the consumption of DC rich in polyphenols can induce a change in glucose levels
Measured: Baseline and week 4
Determine if the consumption of DC rich in polyphenols can induce a change in Lipid profile (TC, HDL, LDL & TG)
Measured: Baseline and week 4
Determine if the consumption of DC rich in polyphenols can induce a change in oxidized LDL levels
Measured: Baseline and week 4
Determine if the consumption of DC rich in polyphenols can induce a change in BMI and Waist circumference
Measured: Baseline and week 4
Determine if the consumption of DC rich in polyphenols can induce a change in blood pressure
Measured: Baseline and week 4
Determine if the consumption of DC rich in polyphenols can induce a change in salivary cortisol-to-cortisone ratio
Measured: Baseline and week 4
Determine if the consumption of DC rich in polyphenols can induce a change in high sensitivity CRP
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- Barry Callebaut
- Responsible party
- Principal investigator, Grace Farhat, Queen Margaret University
- Investigators
- Emad Al-Dujaili, PhD, Study director, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749020
- Sponsor's protocol ID
- DC-Ins01
- Status last verified
- Nov 2013
- First submitted
- 10 Dec 2012
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight Adults
- ClinicalTrials.gov ID
- NCT01749020
- Acronym / sponsor ID
- DC-Ins01
- Conditions
- Insulin Resistance
- Keywords
- Diabetes type II, Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- Barry Callebaut
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyphenol-rich Dark chocolate | Experimental | Other: Polyphenol-rich Dark chocolateDark chocolate with 500 mg of polyphenols |
| Placebo Dark chocolate | Placebo comparator | Other: Placebo Dark chocolateThis chocolate contains little or no polyphenols |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyphenol-rich Dark chocolateParticipants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks | Other | Polyphenol-rich Dark chocolate |
| Placebo Dark chocolateParticipants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 4 weeks | Other | Placebo Dark chocolate |
Primary outcome
Determine if the consumption of DC rich in polyphenols can induce a change in insulin sensitivity
Time frame: Baseline and week 4
Insulin sensitivity will be determined by determined by HOMA-IR (Homeostasis Model of Assessment - Insulin Resistance)
7 secondary outcomes
Determine if the consumption of DC rich in polyphenols can induce a change in glucose levels
Time frame: Baseline and week 4
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
Determine if the consumption of DC rich in polyphenols can induce a change in oxidized LDL levels
Time frame: Baseline and week 4
Determine if the consumption of DC rich in polyphenols can induce a change in BMI and Waist circumference
Time frame: Baseline and week 4
Determine if the consumption of DC rich in polyphenols can induce a change in blood pressure
Time frame: Baseline and week 4
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
Determine if the consumption of DC rich in polyphenols can induce a change in high sensitivity CRP
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad Al-Dujaili, PhD study director
Queen Margaret University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol-rich Dark chocolate in people with Insulin Resistance, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if the consumption of DC rich in polyphenols can induce a change in insulin sensitivity (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2013.