Insulin ResistanceNCT01201590
The Effects of Cocoa Flavanols on Insulin Resistance in an 'At-risk' Population
A study testing High Flavanol Cocoa and Low Flavanol Cocoa in people with Insulin Resistance, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The aim of the current study is to investigate the ability of antioxidants found in cocoa ('flavanols') to increase the body's sensitivity to the hormone insulin. 32 overweight or mildly obese women, who are otherwise healthy, will be recruited. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- High Flavanol Cocoa and Low Flavanol Cocoa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to Oct 2010
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female,
- aged > 18 years,
- pre-menopausal,
- Body Mass Index (BMI)27-35,
- homeostatic model assessment-Insulin Resistance(HOMA-IR)value > 1.5,
- daily consumption of caffeine containing foods/drinks
Who cannot join
- pregnant or breast feeding,
- any metabolic or endocrine abnormalities,
- clinically significant abnormalities on screening,
- fasting glucose > 6.0mmol/l,
- taking medication other than the contraceptive pill,
- herbal supplement use,
- food allergies related to the investigational product (cocoa, peanuts, milk)
- sensitivity to methylxanthines (e.g., caffeine, theobromine)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
David Greenfield Physiology Laboratories, University of Nottingham
Nottingham, Notts, NG72UH
About this study
Official title: The Effects of Cocoa Flavanols on Insulin Resistance in at 'At-risk' Population
The aim of the current study is to investigate the ability of antioxidants found in cocoa ('flavanols') to increase the body's sensitivity to the hormone insulin. 32 overweight or mildly obese women, who are otherwise healthy, will be recruited. Subjects will attend the laboratory on 3 occasions after fasting from midnight. The 1st visit is a medical screening, with laboratory visits 2 and 3 separated by 4 weeks, during which time subjects will consume a cocoa drink (containing either high or low amounts of flavanols) twice a day. Subjects will record their food intake for 3-days before visit 2 and in week 3 of consuming the cocoa. They will also eat a diet of standard macronutrient composition for 3 days before visits 2 and 3. During the 5 hour laboratory visits, subjects will have a scan to assess their body composition using a low-dose x-ray machine (Dual Energy X-ray Absorptiometry; DEXA), and have their insulin sensitivity measured using a 3 hour hyperinsulinemic, euglycaemic Clamp.
Read the detailed description
Background; Overweight and mild obesity are associated with insulin resistance and mild elevations in lipid risk factors which are not usually sufficiently abnormal to merit treatment. Such people are encouraged to lose weight to reduce their risk of progressing to type 2 diabetes and coronary heart disease, but there is clearly a potential role for dietary modifications to maximize any potential benefit of this weight loss. Cocoa flavanols (CF) are known to have vascular effects which might enhance substrate delivery to metabolically active tissues, and thus improve insulin sensitivity.
Aims; This randomized, double blind, placebo controlled, parallel design study aims to investigate the longer term effects of CF intake on insulin sensitivity. It is hypothesized that studying otherwise healthy overweight and mildly obese subjects, with evidence of fasting insulin resistance, would show whether there was potential benefit of CF in an 'at risk' population.
Experimental protocol and methods; 32 overweight or obese women (Body Mass Index 27-35), who are otherwise healthy, will be recruited onto the study. They will attend the 'David Greenfield Human Physiology' laboratories on 3 convenient mornings, following an overnight fast. The 1st visit is a medical screening and will involve signing a consent form, completing a medical screening and food frequency questionnaire, having height, weight, hip/waist circumference measurements taken and a 10ml sample of blood taken for routine analysis. Subjects will then be asked to complete a 3-day diet diary for macronutrient assessment and to consume a diet providing 50% of energy as carbohydrate for 3 days prior to the 2nd laboratory visit. This 2nd visit will involve having a DEXA body composition scan and a 3-hour hyperinsulinaemic, euglycaemic glucose clamp. Starting on the following morning, subjects will then consume a cocoa drink (containing either 450mg or 25mg of CF) twice a day for 28 days. A 3-day diet diary for macronutrient assessment will be recorded during week 3 of taking the cocoa and a standardized diet will be consumed for 3 days prior to the final laboratory visit, as before. This 3rd visit will be identical to visit 2 and occur immediately after 28days of taking the cocoa.
Measurable end points Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight.min), Respiratory exchange ratio, Resting metabolic rate, Homeostatic model assessment for insulin resistance (HOMA-IR) Body composition (DEXA) Macronutrient composition of the diet before and during the intervention period
- Conditions
- Insulin Resistance
- Being tested
- High Flavanol Cocoa, Low Flavanol Cocoa
- Keywords
- Insulin resistance, obesity, cocoa, women
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flavanol CocoaDietary supplement
cocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning \& early evening on an empty stomach), for 4 weeks.
Low Flavanol CocoaDietary supplement
cocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning \& early evening on an empty stomach), for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Flavanol Cocoa | Experimental | 609mg cocoa flavanols per 24g serving Receives: Dietary Supplement: High Flavanol Cocoa |
| Low flavanol cocoa | Placebo comparator | 13mg cocoa flavanols per 24g serving Receives: Dietary Supplement: Low Flavanol Cocoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight/min),
Insulin sensitivity calculated from glucose disposal during a hyperinsulinemic, euglycemic glucose clamp
Measured: after 28 days of supplementation
Secondary outcomes (1)
Change in Glucose Oxidation rate
Measured by ventilated hood indirect calorimetry during the glucose clamp.
Measured: after 28 days of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startMar 2009
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Mars, Inc.
- Responsible party
- Principal investigator, Elizabeth Simpson, University of Nottingham
- Investigators
- Ian A Macdonald, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201590
- Sponsor's protocol ID
- 1000165377
- Status last verified
- Feb 2023
- First submitted
- 30 Sep 2009
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Simpson EJ, Mendis B, Dunlop M, Schroeter H, Kwik-Uribe C, Macdonald IA. Cocoa Flavanol Supplementation and the Effect on Insulin Resistance in Females Who Are Overweight or Obese: A Randomized, Placebo-Controlled Trial. Nutrients. 2023 Jan 21;15(3):565. doi: 10.3390/nu15030565.
PubMed 36771271
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cocoa Flavanols on Insulin Resistance in at 'At-risk' Population
- ClinicalTrials.gov ID
- NCT01201590
- Acronym / sponsor ID
- 1000165377
- Conditions
- Insulin Resistance
- Keywords
- Insulin resistance, obesity, cocoa, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- Mar 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 Sep 2010 (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 aim of the current study is to investigate the ability of antioxidants found in cocoa ('flavanols') to increase the body's sensitivity to the hormone insulin. 32 overweight or mildly obese women, who are otherwise healthy, will be recruited. Subjects will attend the laboratory on 3 occasions after fasting from midnight. The 1st visit is a medical screening, with laboratory visits 2 and 3 separated by 4 weeks, during which time subjects will consume a cocoa drink (containing either high or low amounts of flavanols) twice a day. Subjects will record their food intake for 3-days before visit 2 and in week 3 of consuming the cocoa. They will also eat a diet of standard macronutrient composition for 3 days before visits 2 and 3. During the 5 hour laboratory visits, subjects will have a scan to assess their body composition using a low-dose x-ray machine (Dual Energy X-ray Absorptiometry; DEXA), and have their insulin sensitivity measured using a 3 hour hyperinsulinemic, euglycaemic Clamp.
Detailed description
Background; Overweight and mild obesity are associated with insulin resistance and mild elevations in lipid risk factors which are not usually sufficiently abnormal to merit treatment. Such people are encouraged to lose weight to reduce their risk of progressing to type 2 diabetes and coronary heart disease, but there is clearly a potential role for dietary modifications to maximize any potential benefit of this weight loss. Cocoa flavanols (CF) are known to have vascular effects which might enhance substrate delivery to metabolically active tissues, and thus improve insulin sensitivity.
Aims; This randomized, double blind, placebo controlled, parallel design study aims to investigate the longer term effects of CF intake on insulin sensitivity. It is hypothesized that studying otherwise healthy overweight and mildly obese subjects, with evidence of fasting insulin resistance, would show whether there was potential benefit of CF in an 'at risk' population.
Experimental protocol and methods; 32 overweight or obese women (Body Mass Index 27-35), who are otherwise healthy, will be recruited onto the study. They will attend the 'David Greenfield Human Physiology' laboratories on 3 convenient mornings, following an overnight fast. The 1st visit is a medical screening and will involve signing a consent form, completing a medical screening and food frequency questionnaire, having height, weight, hip/waist circumference measurements taken and a 10ml sample of blood taken for routine analysis. Subjects will then be asked to complete a 3-day diet diary for macronutrient assessment and to consume a diet providing 50% of energy as carbohydrate for 3 days prior to the 2nd laboratory visit. This 2nd visit will involve having a DEXA body composition scan and a 3-hour hyperinsulinaemic, euglycaemic glucose clamp. Starting on the following morning, subjects will then consume a cocoa drink (containing either 450mg or 25mg of CF) twice a day for 28 days. A 3-day diet diary for macronutrient assessment will be recorded during week 3 of taking the cocoa and a standardized diet will be consumed for 3 days prior to the final laboratory visit, as before. This 3rd visit will be identical to visit 2 and occur immediately after 28days of taking the cocoa.
Measurable end points Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight.min), Respiratory exchange ratio, Resting metabolic rate, Homeostatic model assessment for insulin resistance (HOMA-IR) Body composition (DEXA) Macronutrient composition of the diet before and during the intervention period
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flavanol Cocoa | Experimental | Dietary Supplement: High Flavanol Cocoa609mg cocoa flavanols per 24g serving |
| Low flavanol cocoa | Placebo comparator | Dietary Supplement: Low Flavanol Cocoa13mg cocoa flavanols per 24g serving |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- female,
- aged > 18 years,
- pre-menopausal,
- Body Mass Index (BMI)27-35,
- homeostatic model assessment-Insulin Resistance(HOMA-IR)value > 1.5,
Key exclusion criteria (8 listed)
- pregnant or breast feeding,
- any metabolic or endocrine abnormalities,
- clinically significant abnormalities on screening,
- fasting glucose > 6.0mmol/l,
- taking medication other than the contraceptive pill,
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 |
|---|---|---|
| High Flavanol Cocoacocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning \& early evening on an empty stomach), for 4 weeks. | Dietary supplement | High Flavanol Cocoa |
| Low Flavanol Cocoacocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning \& early evening on an empty stomach), for 4 weeks. | Dietary supplement | Low flavanol cocoa |
Primary outcome
Change in Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight/min),
Time frame: after 28 days of supplementation
Insulin sensitivity calculated from glucose disposal during a hyperinsulinemic, euglycemic glucose clamp
1 secondary outcome
Change in Glucose Oxidation rate
Time frame: after 28 days of supplementation
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 6 Feb 2023.
- Results publication: PubMed 36771271Simpson EJ, Mendis B, Dunlop M, Schroeter H, Kwik-Uribe C, Macdonald IA. Cocoa Flavanol Supplementation and the Effect on Insulin Resistance in Females Who Are Overweight or Obese: A Randomized, Placebo-Controlled Trial. Nutrients. 2023 Jan 21;15(3):565. doi: 10.3390/nu15030565.
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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.
Ian A Macdonald, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flavanol Cocoa and Low Flavanol Cocoa in people with Insulin Resistance, run by University of Nottingham 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 6 inclusion and 8 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 6 Feb 2023. 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?
Change in Insulin sensitivity 'M' value (mg glucose disposal from the blood/kg body weight/min), (time frame: after 28 days of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01201590, which also lists 1 linked publication.
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 6 Feb 2023.