Microangiopathy, DiabeticNCT05449782
Macro- and Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes
A study testing Cocoa flavanol in people with Microangiopathy, Diabetic and Polyphenol, run by University of Surrey at 1 site in United Kingdom.
Trial summary
The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Microangiopathy, Diabetic, Polyphenol, Optical Tomography
- What is being tested?
- Cocoa flavanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2021to 17 May 2022
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, 20-70 years
- BMI 20-30 kg/m^2
- Type 2 diabetes mellitus
- 20-70 years
- BMI 20-30 kg/m^2
Who cannot join
- Diabetes mellitus
- Symptoms of acute infection
- Cardiac rhythm other than sinus
- Active malignancy
- Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication
- Active vasoactive medication.
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- Type 2 Diabetes:
- Symptoms of acute infection
- Cardiac rhythm other than sinus
- Active malignancy
- Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication
- Active vasoactive medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof-of-concept Study to Investigate Hand and Foot Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes Participant
The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. Specific diets with high polyphenol content are associated with lower incidence of cardiovascular disease and can improve macrovascular function when consumed acutely and chronically. Which role the smallest blood vessels (microcirculation) play in this and if the microcirculation responds to therapies is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation.
The current randomised controlled cross-over proof-of-concept study will test the acute effect of a cocoa flavanol intervention on cutaneous microvascular structure and function of hands and feet together with macrovascular function of upper and lower extremities in healthy and type 2 diabetes participants. It is the hypothesis that cocoa flavanol intervention as compared to placebo can acutely increase microvascular vasodilation and macrovascular endothelial function in arms and legs together with arterial stiffness in both healthy and type 2 diabetes participants.
- Conditions
- Microangiopathy, Diabetic, Polyphenol, Optical Tomography, Vascular Endothelium, Arterial Stiffness, Healthy Participants
- Being tested
- Cocoa flavanol, Placebo
- Medical subject headings
- Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa flavanolDietary supplement
Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules)
PlaceboOther
Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants: Cocoa flavanol - Placebo | Other | Healthy participants receiving cocoa flavanols on first study day and placebo on second study day Receives: Dietary Supplement: Cocoa flavanol; Other: Placebo |
| Healthy participant: Placebo - Cocoa flavanol | Other | Healthy participants receiving placebo on first study day and cocoa flavanols on second study day Receives: Dietary Supplement: Cocoa flavanol; Other: Placebo |
| Type 2 diabetes participants: Cocoa flavanol - Placebo | Other | Participants with type 2 diabetes receiving cocoa flavanols on first study day and placebo on second study day Receives: Dietary Supplement: Cocoa flavanol; Other: Placebo |
| Type 2 diabetes participants: Placebo - Cocoa flavanol | Other | Participants with type 2 diabetes receiving placebo on first study day and cocoa flavanols on second study day Receives: Dietary Supplement: Cocoa flavanol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular dilation
Microvascular diameter increase in response to 5 min limb occlusion on hands and feet
Measured: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Macrovascular endothelial function
Flow-mediated dilation determined with ultrasound in brachial and common femoral artery
Measured: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Secondary outcomes (3)
Arterial stiffness
Pulse wave velocity (Arteriograph)
Measured: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Blood pressure
Upper arm blood pressure measured with Arteriograph
Measured: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Leg perfusion pressure
Doppler based perfusion pressure of leg
Measured: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start17 May 2021
- Primary completion1 Jun 2021
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microangiopathy, DiabeticStudies 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
- Crossover
- Model description
- 2 group (healthy and type 2 diabetes) randomised controlled cross-over (2-period, 2-sequence) study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Heiss, Prof., Principal investigator, University of Surrey, Department of Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449782
- Sponsor's protocol ID
- OCTA2
- Status last verified
- May 2022
- First submitted
- 18 May 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be decided on an individual basis and after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Study to Investigate Hand and Foot Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes Participant
- ClinicalTrials.gov ID
- NCT05449782
- Acronym / sponsor ID
- OCTA2
- Conditions
- Microangiopathy, Diabetic, Polyphenol, Optical Tomography, Vascular Endothelium, Arterial Stiffness, Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 8 Jul 2022 (actual)
- 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 greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. Specific diets with high polyphenol content are associated with lower incidence of cardiovascular disease and can improve macrovascular function when consumed acutely and chronically. Which role the smallest blood vessels (microcirculation) play in this and if the microcirculation responds to therapies is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation.
The current randomised controlled cross-over proof-of-concept study will test the acute effect of a cocoa flavanol intervention on cutaneous microvascular structure and function of hands and feet together with macrovascular function of upper and lower extremities in healthy and type 2 diabetes participants. It is the hypothesis that cocoa flavanol intervention as compared to placebo can acutely increase microvascular vasodilation and macrovascular endothelial function in arms and legs together with arterial stiffness in both healthy and type 2 diabetes participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2 group (healthy and type 2 diabetes) randomised controlled cross-over (2-period, 2-sequence) study
| Arm | Type | Receives |
|---|---|---|
| Healthy participants: Cocoa flavanol - Placebo | Other | Dietary Supplement: Cocoa flavanol, Other: PlaceboHealthy participants receiving cocoa flavanols on first study day and placebo on second study day |
| Healthy participant: Placebo - Cocoa flavanol | Other | Dietary Supplement: Cocoa flavanol, Other: PlaceboHealthy participants receiving placebo on first study day and cocoa flavanols on second study day |
| Type 2 diabetes participants: Cocoa flavanol - Placebo | Other | Dietary Supplement: Cocoa flavanol, Other: PlaceboParticipants with type 2 diabetes receiving cocoa flavanols on first study day and placebo on second study day |
| Type 2 diabetes participants: Placebo - Cocoa flavanol | Other | Dietary Supplement: Cocoa flavanol, Other: PlaceboParticipants with type 2 diabetes receiving placebo on first study day and cocoa flavanols on second study day |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy, 20-70 years
- BMI 20-30 kg/m^2
- Type 2 diabetes mellitus
- 20-70 years
- BMI 20-30 kg/m^2
Key exclusion criteria (12 listed)
- Diabetes mellitus
- Symptoms of acute infection
- Cardiac rhythm other than sinus
- Active malignancy
- Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication
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 |
|---|---|---|
| Cocoa flavanolCommercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules) | Dietary supplement | Healthy participant: Placebo - Cocoa flavanol, Healthy participants: Cocoa flavanol - Placebo, Type 2 diabetes participants: Cocoa flavanol - Placebo, Type 2 diabetes participants: Placebo - Cocoa flavanol |
| PlaceboCapsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules) | Other | Healthy participant: Placebo - Cocoa flavanol, Healthy participants: Cocoa flavanol - Placebo, Type 2 diabetes participants: Cocoa flavanol - Placebo, Type 2 diabetes participants: Placebo - Cocoa flavanol |
Primary outcome
Microvascular dilation
Time frame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Microvascular diameter increase in response to 5 min limb occlusion on hands and feet
Macrovascular endothelial function
Time frame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Flow-mediated dilation determined with ultrasound in brachial and common femoral artery
3 secondary outcomes
Arterial stiffness
Time frame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Blood pressure
Time frame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Leg perfusion pressure
Time frame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
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 8 Jul 2022.
- Individual participant dataSharing planned: No. Will be decided on an individual basis and after study completion.
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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.
Christian Heiss, Prof. principal investigator
University of Surrey, Department of Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa flavanol in people with Microangiopathy, Diabetic and Polyphenol, run by University of Surrey 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 5 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 8 Jul 2022. 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. 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?
Microvascular dilation (time frame: Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo). The study lists 2 primary outcomes in all. 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 8 Jul 2022.