DiabetesNCT01654172
Effect of Flavanol-rich Cocoa on Peripheral and Cerebral Blood Flow in Type 2 Diabetes
A study testing High Flavanol Cocoa and Low Flavanol Cocoa in people with Diabetes, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Cocoa flavanols form part of the family of chemicals (also found in red wine and tea) which have aroused interest due to population studies suggesting that diets high in these substances might reduce risks of heart disease. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes
- 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
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2006to Dec 2008
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Peripheral neuropathy or free from neuropathy
Who cannot join
- Current foot ulceration
- Hypertension
- Anti-hypertensive medications other than thiazide diuretics and ACE inhibitors
- Ischaemic heart disease
- Peripheral vascular disease (ABPI ,0.9 \&/or impalpable foot pulses)
- Chronic kidney disease
Show all 12Show fewer
- Poor glycaemic control
- DVT
- Epilepsy
- Pregnancy
- Contraindications to MRI
- Intolerance to lactose or cow's milk protein
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Notts, NG72UH
About this study
Cocoa flavanols form part of the family of chemicals (also found in red wine and tea) which have aroused interest due to population studies suggesting that diets high in these substances might reduce risks of heart disease. In the laboratory, these flavanols have been shown to cause blood vessels to widen and blood flow to increase. As dysfunction in this ability of blood vessels to widen is now thought to play a central role in the complications of diabetes, novel ways to mitigate this are constantly being sought.
The present study aims to use non-invasive magnetic resonance imaging (MRI) to measure foot and brain blood flow before and after 7 days consumption of a cocoa drink high in flavanols, in subjects with diabetes, with and without peripheral neuropathy.
Read the detailed description
Cocoa flavanols form part of the family of polyphenols (also found in red wine and tea) which have aroused interest due to epidemiological studies suggesting that diets high in these substances might reduce risks of heart disease. However, it is difficult to account for all sources of polyphenols in these epidemiological studies, and the level of cocoa product consumption was generally not well documented. Furthermore, in readily available cocoa products, processing may remove most of the flavanols, leading to such products varying considerably in flavanol content. Recently, laboratory studies of the effects of cocoa flavanols have suggested an effect on the relaxation of smooth muscle in blood vessel walls, specifically the element mediated by the endothelium (blood vessel wall). Studies using ultrasound methods in healthy volunteers have shown an increase in blood flow in the arm following temporary arterial occlusion.
As endothelial dysfunction is now thought to play a central role in the complications of diabetes, novel ways to mitigate this are constantly being sought. It is well recognised that diabetic peripheral nerve damage leads to abnormal foot blood flow, including impaired superficial skin blood flow, and that this is one of the factors delaying wound healing in diabetic foot ulcers (the single largest cost in secondary care diabetes).
Several techniques are currently used to monitor blood flow to the limbs, including venous occlusion plethysmography (VOP), laser Doppler methods and nuclear medicine techniques. These techniques have low spatial resolution, low specificity, are labour intensive, or require the use of injected radioactive contrast agents (which pose a particular risk to diabetic patients). Radiation dose also limits repeat studies.
The arterial spin labelling magnetic resonance (ASL MR) technique is non-invasive, but yields a quantifiable measure of blood flow with high resolution, and allows measurements to be repeated several times, as the technique uses no external contrast agents.
The present study aims to use non-invasive magnetic resonance imaging (MRI) to measure peripheral (foot) and brain blood flow at baseline and in response to a cocoa drink high in flavanols, in subjects with type 2 diabetes, with and without peripheral neuropathy.
Subjects will attend an initial screening visit. Measures of HbA1c, kidney function and blood pressure will be checked, along with ankle-brachial pressure index (to check for poor circulation), foot pulses, and examination for peripheral nerve damage and cardiac neuropathy.
- Conditions
- Diabetes
- Being tested
- High Flavanol Cocoa, Low Flavanol Cocoa
- Keywords
- Diabetes, peripheral neuropathy, Cocoa flavanols
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flavanol CocoaDietary supplement
Total daily flavanol intake provided by the high flavanol drink is ~900mg
Low Flavanol CocoaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| High Flavanol Cocoa | Experimental | Cocoa drink containing ~450mg cocoa flavanols and 10g carbohydrate per serving.
Subject consumes 2 servings per day, for 7 days. Receives: Dietary Supplement: High Flavanol Cocoa |
| Low Flavanol Cocoa | Placebo comparator | Cocoa drink containing ~25mg cocoa flavanols and 10g carbohydrate per serving.
Subject consumes 2 servings per day, for 7 days. 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 Fasting Brain Blood Flow
Measured by ASL-MR at Day 0 and after 7d consumption of a cocoa drink to detect a change following intervention
Measured: Day 0 and after 7d consumption of a cocoa drink
Secondary outcomes (6)
Change in Brain blood flow after acute consumption of cocoa
Measured at day 0, (before intervention commences)and after 7days consumption of a cocoa drink
Measured: 1,3,5 and 8hrs after cocoa consumption
Change in Fasting foot blood flow
Measured using ASL-MR
Measured: Day 0 and after 7d consumption of a cocoa drink
Change in Foot blood flow after acute consumption of cocoa
Measured at day 0, (before intervention commences)and after 7days consumption of a cocoa drink
Measured: 1,3,5 and 8hrs after cocoa consumption
Change in Blood Flavanol concentration
Measured at day 0, (before intervention commences)and after 7days consumption of a cocoa drink
Measured: Day 0 and after 7d consumption of a cocoa drink
Change in Fasting oxidative stress status
Oxidative stress assessed by measuring concentration of homocysteine, CRP, 8-isoprostaglandin, arginine and nitric oxide metabolites in the blood.
Measured: Day 0 and after 7 days of consuming a cocoa drink
Change in diabetes control
Assessment made from HbA1c, glucose and insulin concentration in the blood
Measured: Day 0 and after 7days of consuming a cocoa drink daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startSep 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Mars, Inc.
- Responsible party
- Sponsor
- Investigators
- Simon Paige, MD, Principal investigator, University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654172
- Sponsor's protocol ID
- 05/Q2401/146
- Status last verified
- Jul 2012
- First submitted
- 25 Jul 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flavanol-rich Cocoa on Peripheral and Cerebral Blood Flow in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01654172
- Acronym / sponsor ID
- 05/Q2401/146
- Conditions
- Diabetes
- Keywords
- Diabetes, peripheral neuropathy, Cocoa flavanols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- Sep 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 31 Jul 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.
Cocoa flavanols form part of the family of chemicals (also found in red wine and tea) which have aroused interest due to population studies suggesting that diets high in these substances might reduce risks of heart disease. In the laboratory, these flavanols have been shown to cause blood vessels to widen and blood flow to increase. As dysfunction in this ability of blood vessels to widen is now thought to play a central role in the complications of diabetes, novel ways to mitigate this are constantly being sought.
The present study aims to use non-invasive magnetic resonance imaging (MRI) to measure foot and brain blood flow before and after 7 days consumption of a cocoa drink high in flavanols, in subjects with diabetes, with and without peripheral neuropathy.
Detailed description
Cocoa flavanols form part of the family of polyphenols (also found in red wine and tea) which have aroused interest due to epidemiological studies suggesting that diets high in these substances might reduce risks of heart disease. However, it is difficult to account for all sources of polyphenols in these epidemiological studies, and the level of cocoa product consumption was generally not well documented. Furthermore, in readily available cocoa products, processing may remove most of the flavanols, leading to such products varying considerably in flavanol content. Recently, laboratory studies of the effects of cocoa flavanols have suggested an effect on the relaxation of smooth muscle in blood vessel walls, specifically the element mediated by the endothelium (blood vessel wall). Studies using ultrasound methods in healthy volunteers have shown an increase in blood flow in the arm following temporary arterial occlusion.
As endothelial dysfunction is now thought to play a central role in the complications of diabetes, novel ways to mitigate this are constantly being sought. It is well recognised that diabetic peripheral nerve damage leads to abnormal foot blood flow, including impaired superficial skin blood flow, and that this is one of the factors delaying wound healing in diabetic foot ulcers (the single largest cost in secondary care diabetes).
Several techniques are currently used to monitor blood flow to the limbs, including venous occlusion plethysmography (VOP), laser Doppler methods and nuclear medicine techniques. These techniques have low spatial resolution, low specificity, are labour intensive, or require the use of injected radioactive contrast agents (which pose a particular risk to diabetic patients). Radiation dose also limits repeat studies.
The arterial spin labelling magnetic resonance (ASL MR) technique is non-invasive, but yields a quantifiable measure of blood flow with high resolution, and allows measurements to be repeated several times, as the technique uses no external contrast agents.
The present study aims to use non-invasive magnetic resonance imaging (MRI) to measure peripheral (foot) and brain blood flow at baseline and in response to a cocoa drink high in flavanols, in subjects with type 2 diabetes, with and without peripheral neuropathy.
Subjects will attend an initial screening visit. Measures of HbA1c, kidney function and blood pressure will be checked, along with ankle-brachial pressure index (to check for poor circulation), foot pulses, and examination for peripheral nerve damage and cardiac neuropathy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flavanol Cocoa | Experimental | Dietary Supplement: High Flavanol CocoaCocoa drink containing ~450mg cocoa flavanols and 10g carbohydrate per serving. Subject consumes 2 servings per day, for 7 days. |
| Low Flavanol Cocoa | Placebo comparator | Dietary Supplement: Low Flavanol CocoaCocoa drink containing ~25mg cocoa flavanols and 10g carbohydrate per serving. Subject consumes 2 servings per day, for 7 days. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- Peripheral neuropathy or free from neuropathy
Key exclusion criteria (12 listed)
- Current foot ulceration
- Hypertension
- Anti-hypertensive medications other than thiazide diuretics and ACE inhibitors
- Ischaemic heart disease
- Peripheral vascular disease (ABPI ,0.9 \&/or impalpable foot pulses)
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 CocoaTotal daily flavanol intake provided by the high flavanol drink is ~900mg | Dietary supplement | High Flavanol Cocoa |
| Low Flavanol Cocoa | Dietary supplement | Low Flavanol Cocoa |
Primary outcome
Change in Fasting Brain Blood Flow
Time frame: Day 0 and after 7d consumption of a cocoa drink
Measured by ASL-MR at Day 0 and after 7d consumption of a cocoa drink to detect a change following intervention
6 secondary outcomes
Change in Brain blood flow after acute consumption of cocoa
Time frame: 1,3,5 and 8hrs after cocoa consumption
Change in Fasting foot blood flow
Time frame: Day 0 and after 7d consumption of a cocoa drink
Change in Foot blood flow after acute consumption of cocoa
Time frame: 1,3,5 and 8hrs after cocoa consumption
Change in Blood Flavanol concentration
Time frame: Day 0 and after 7d consumption of a cocoa drink
Change in Fasting oxidative stress status
Time frame: Day 0 and after 7 days of consuming a cocoa drink
Change in diabetes control
Time frame: Day 0 and after 7days of consuming a cocoa drink daily
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 31 Jul 2012.
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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.
Simon Paige, MD principal investigator
University Hospitals NHS Trust
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 Diabetes, 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 2 inclusion and 12 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 31 Jul 2012. 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 Fasting Brain Blood Flow (time frame: Day 0 and after 7d consumption of a cocoa drink). 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 31 Jul 2012.