Type 2 DiabetesNCT01886989
Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes
A study testing Cocoa polyphenols in people with Type 2 Diabetes, run by Arpita Basu at 1 site in United States.
Trial summary
This study aims to investigate the postprandial effects of cocoa supplementation in glucose and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cocoa polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2014
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of type 2diabetes
Who cannot join
- on insulin therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Nutritional Sciences
Stillwater, Oklahoma, 74078
About this study
Official title: Postprandial Effects of Polyphenol-rich Cocoa Beverage on Glucose, Insulin, Lipids, Oxidative Stress and Inflammation in Type 2 Diabetic Patients
This study aims to investigate the postprandial effects of cocoa supplementation in glucose and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. The investigators aim to test the hypothesis that cocoa will lower high-fat mixed meal breakfast-induced postprandial rise of glucose, lipids and markers of atherosclerosis in patients with diabetes. Randomized cross-over controlled trial, in which participants will be assigned to the placebo or cocoa group with breakfast meal. Patients with type 2 diabetes(n=25) will qualify for the study. The participants will be asked to consume 2 cups cocoa or placebo beverage on 2 separate postprandial study days. Both groups will receive high-fat mixed meal breakfast on each day. Blood draws and blood pressure (including HDI) measurements will be conducted at fasting, 30 min, 1,2, 4 \& 6 hours postprandial each day for 2 days.
- Conditions
- Type 2 Diabetes
- Being tested
- Cocoa polyphenols
- Keywords
- diabetes, cocoa polyphenols, postprandial glycemia, postprandial lipemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa polyphenolsDietary supplement
Cocoa polyphenols (960mg) reconstituted in water
| Study group | Role | What they receive |
|---|---|---|
| Cocoa | Experimental | Cocoa polyphenols (960mg) Receives: Dietary Supplement: Cocoa polyphenols |
| Placebo | Placebo comparator | Placebo powder (109mg polyphenols) in water Receives: Dietary Supplement: Cocoa polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (mm Hg)
Change in blood pressure and vascular function following cocoa and placebo intervention
Measured: 2.5 years
Secondary outcomes (3)
Glucose (mg/dL)
Change in glucose levels at fasting, 30min, 1, 2, 4, \& 6 hours postprandial following cocoa and placebo intervention
Measured: 2.5 years
Blood lipids
Change in lipids and lipoprotein levels at fasting, 30min, 1, 2, 4, \& 6 hours postprandial following cocoa
Measured: 2.5 years
Inflammation
Change in CRP and interleukins levels at fasting, 30min, 1, 2, 4, \& 6 hours postprandial following cocoa
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arpita Basu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arpita Basu, Oklahoma State University
- Investigators
- ARPITA BASU, PHD, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886989
- Sponsor's protocol ID
- HE-12-52
- Status last verified
- Jan 2018
- First submitted
- 24 Jun 2013
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davis DW, Tallent R, Navalta JW, Salazar A, Lyons TJ, Basu A. Effects of Acute Cocoa Supplementation on Postprandial Apolipoproteins, Lipoprotein Subclasses, and Inflammatory Biomarkers in Adults with Type 2 Diabetes after a High-Fat Meal. Nutrients. 2020 Jun 27;12(7):1902. doi: 10.3390/nu12071902.
PubMed 32605005Basu A, Betts NM, Leyva MJ, Fu D, Aston CE, Lyons TJ. Acute Cocoa Supplementation Increases Postprandial HDL Cholesterol and Insulin in Obese Adults with Type 2 Diabetes after Consumption of a High-Fat Breakfast. J Nutr. 2015 Oct;145(10):2325-32. doi: 10.3945/jn.115.215772. Epub 2015 Sep 2.
PubMed 26338890
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Effects of Polyphenol-rich Cocoa Beverage on Glucose, Insulin, Lipids, Oxidative Stress and Inflammation in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01886989
- Acronym / sponsor ID
- HE-12-52
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, cocoa polyphenols, postprandial glycemia, postprandial lipemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Arpita BasuUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jun 2013 (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.
This study aims to investigate the postprandial effects of cocoa supplementation in glucose and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. The investigators aim to test the hypothesis that cocoa will lower high-fat mixed meal breakfast-induced postprandial rise of glucose, lipids and markers of atherosclerosis in patients with diabetes. Randomized cross-over controlled trial, in which participants will be assigned to the placebo or cocoa group with breakfast meal. Patients with type 2 diabetes(n=25) will qualify for the study. The participants will be asked to consume 2 cups cocoa or placebo beverage on 2 separate postprandial study days. Both groups will receive high-fat mixed meal breakfast on each day. Blood draws and blood pressure (including HDI) measurements will be conducted at fasting, 30 min, 1,2, 4 \& 6 hours postprandial each day for 2 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cocoa | Experimental | Dietary Supplement: Cocoa polyphenolsCocoa polyphenols (960mg) |
| Placebo | Placebo comparator | Dietary Supplement: Cocoa polyphenolsPlacebo powder (109mg polyphenols) in water |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- clinical diagnosis of type 2diabetes
Key exclusion criteria (1 listed)
- on insulin 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 |
|---|---|---|
| Cocoa polyphenolsCocoa polyphenols (960mg) reconstituted in water | Dietary supplement | Cocoa, Placebo |
Primary outcome
Blood pressure (mm Hg)
Time frame: 2.5 years
Change in blood pressure and vascular function following cocoa and placebo intervention
3 secondary outcomes
Glucose (mg/dL)
Time frame: 2.5 years
Blood lipids
Time frame: 2.5 years
Inflammation
Time frame: 2.5 years
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 23 Jan 2018.
- Derived from this study: PubMed 32605005Davis DW, Tallent R, Navalta JW, Salazar A, Lyons TJ, Basu A. Effects of Acute Cocoa Supplementation on Postprandial Apolipoproteins, Lipoprotein Subclasses, and Inflammatory Biomarkers in Adults with Type 2 Diabetes after a High-Fat Meal. Nutrients. 2020 Jun 27;12(7):1902. doi: 10.3390/nu12071902.
- Derived from this study: PubMed 26338890Basu A, Betts NM, Leyva MJ, Fu D, Aston CE, Lyons TJ. Acute Cocoa Supplementation Increases Postprandial HDL Cholesterol and Insulin in Obese Adults with Type 2 Diabetes after Consumption of a High-Fat Breakfast. J Nutr. 2015 Oct;145(10):2325-32. doi: 10.3945/jn.115.215772. Epub 2015 Sep 2.
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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.
ARPITA BASU, PHD principal investigator
Oklahoma State 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 Cocoa polyphenols in people with Type 2 Diabetes, run by Arpita Basu at 1 site in United States.
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 1 inclusion and 1 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 23 Jan 2018. 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 States. 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?
Blood pressure (mm Hg) (time frame: 2.5 years). 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 NCT01886989, which also lists 2 linked publications.
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 23 Jan 2018.