- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02203240
Cocoa and Metabolic Health in Prediabetes
September 18, 2023 updated by: Andrew P. Neilson, Virginia Polytechnic Institute and State University
Dietary Cocoa for Inhibition of Metabolic Endotoxemia and Glucose Intolerance
The purpose of this study is to determine the impact of consuming cocoa on blood glucose levels, glucose metabolism, and other markers of pre-diabetes in overweight and/or obese individuals.
Our hypothesis is that consumption of cocoa improves insulin sensitivity and glucose metabolism in subjects at risk for developing type-2 diabetes.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Blacksburg, Virginia, United States, 24061
- Human Integrative Physiology Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Body Mass Index (BMI) greater than or equal to 25 and less than 40.
- Have at least one of the following: 1) impaired fasting glucose (IFG) after an overnight fast with plasma glucose concentration between 100-125 mg/dl, 2) impaired glucose tolerance (IGT) as identified by the standard Oral Glucose Tolerance Test (OGTT) with 2 hour plasma glucose concentration between 140-200 mg/dl following 75 g glucose OGTT, 3) HbA1c levels between 5.7-6.4% or 4) considered at risk to developing type 2 diabetes by the American Diabetes Association risk assessment. If subjects are above the prediabetic range for any of these tests (indicating they may be type 2 diabetic), they will be excluded and referred to their physician.
- Weight stable (+/-2 kg) for the last 6 months.
- Sedentary to recreationally active (less than 2 d/wk, 20 min/d).
- Have a blood pressure that is less than 160/100 mmHg, total cholesterol that is less than 300 mg/dl and a triglyceride concentration of less than 450 mg/dl.
Exclusion Criteria:
- Past or current history of coronary heart disease, stroke or major cardiovascular disease events, respiratory diseases, endocrine or metabolic diseases (including type 1 and type 2 diabetes), inflammatory bowel disease, cancer, or neurological or hematological disorders that would compromise the study or the health of the subject.
- Past or current history of gastrointestinal disorders (including lactose intolerance, ulcers, cancer (stomach, intestinal, colon, pancreatic, liver, etc) NASH, NAFLD, cirrhosis, IBD/IBS, celiac disease, etc).
- Current use of any medication including but not limited to cholesterol lowering medication (including fibric acid derivatives and niacin), antibiotics, immunosuppressive drugs, azole antifungals, non-steroidal anti-inflammatory drugs (NSAIDs), hormone replacement therapy or antioxidants/supplements.
- Use of antibiotics, prebiotics, or probiotics within the prior 3 months.
- Smoking or other tobacco use
- Habitual consumption of alcohol more than 2 servings/d for males and 1 serving/d for females.
- Strict vegetarians or vegans, or strong aversions to major food groups that may be part of the controlled diet.
- Recent surgery
- History of alcohol or drug abuse.
- Pregnant or plan to become pregnant
- Allergic to either lidocaine or bupivacaine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cocoa
3 servings of polyphenol-rich cocoa beverage consumed per day.
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Placebo Comparator: Placebo
3 servings of non-cocoa beverage consumed per day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in insulin sensitivity
Time Frame: Baseline and 4 weeks
|
Insulin sensitivity will be determined using Bergman's minimal model (MINMOD Millennium software) via a frequently sampled intravenous glucose tolerance test (IVGTT).
Fasting baseline blood samples will be taken prior to the dextrose injection (0.3 g/kg; 50% solution) at minute 0. Venous samples will be collected at minutes 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 16, and 18. Insulin (0.025 U/kg) will be injected at minute 20.
Venous sampling will continue at minutes 22, 23, 24, 25, 27, 30, 40, 50, 60, 70, 80, 90, 100, 120, 150, and 180.
Glucose concentration will be immediately analyzed an automated glucose oxidase analyzer.
Insulin will be later measured from serum using the Immulite 1000 immunoassay analyzer.
|
Baseline and 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood glucose response to a mixed meal
Time Frame: Baseline and 1 week
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The test meal will be 2-8 oz.
servings of a meal replacement beverage providing a mixed macronutrient profile, supplemented with either a cocoa beverage dry mix (10 g cocoa) or a calorie-matched placebo beverage mix (0 g cocoa).
Blood samples will be taken at baseline and subsequently 1, 2, 3, and 4 hours after the first sip of the test beverage.
Plasma glucose concentrations will be analyzed immediately using a glucose auto-analyzer (Yellow Springs Instruments).
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Baseline and 1 week
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Change in hormone secretion response to a mixed meal
Time Frame: Baseline and 1 week
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Serum insulin, GLP-1, GIP, and C-peptide concentrations will be determined using commercially available enzyme-linked immunosorbent assay (ELISA) kits from the blood samples drawn at baseline, 1, 2, 3, and 4 hours during the mixed meal challenge.
|
Baseline and 1 week
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Change in skeletal muscle metabolic flexibility
Time Frame: Baseline and 4 weeks
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Subjects will consume a high fat meal containing 820 kcal; 52 g total carbohydrates, 24 g protein, and 58 g fat.
During the high fat challenge session, two skeletal muscle biopsies will be conducted on alternate legs; one before the high fat meal and one 4 hours later.
Biopsies of the vastus lateralis will be performed using a 5 mm modified Bergström needle.
Collected tissue will be washed in 0.9% sterile saline to remove blood and tissue.
Samples will be weighed and added to buffer and placed on ice for immediate analysis of substrate flexibility.
For substrate flexibility, pyruvate oxidation will be used to assess the activity of pyruvate dehydrogenase.
Calculated metabolic flexibility is expressed as a ratio of pyruvate oxidation to pyruvate oxidation + free fatty acids.
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Baseline and 4 weeks
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Change in blood endotoxin levels
Time Frame: Baseline and 4 weeks
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During the high fat challenge (see Outcome 4), blood samples will be collected at baseline and 1, 2, 3, and 4 h after the first bite of the meal.
Serum endotoxin will be measured in duplicate using Limulus Amebocyte Lysate Pyrogent ® 5000 assay kits.
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Baseline and 4 weeks
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Change in gut permeability
Time Frame: Baseline and 4 weeks
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The four-sugar [40 g sucrose, 1 g mannitol, 1 g sucralose and 5 g lactulose] probe test will be used to assess total gut permeability.
After an overnight fast and urine evacuation, participants will be asked to consume the sugar-probe beverage within 5 minutes.
They will be given two breakfast sandwiches to consume immediately.
Participants will be instructed to collect all of their urine in a provided container from the time the beverage was consumed (0 h) until 5 h.
A second urine collection container will be filled between 6-24 h.
Twenty-four hours later, the volume of urine in each container will be measured and aliquots collected for later analysis.
Gastroduodenal permeability is defined as sucrose/mannitol ratio (0-5 h).
Small intestinal permeability is defined as the calculated lactulose/mannitol ratio for 0-5 samples.
Colonic permeability is defined as both the 6-24 h lactulose/mannitol ratio and 6-24 h sucralose/mannitol ratio.
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Baseline and 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrew P Neilson, PhD, Virginia Polytechnic Institute and State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
July 26, 2014
First Submitted That Met QC Criteria
July 26, 2014
First Posted (Estimated)
July 29, 2014
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 18, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VT13261005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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