Cocoa and Metabolic Health in Prediabetes
Dietary Cocoa for Inhibition of Metabolic Endotoxemia and Glucose Intolerance
1 other identifier
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 26, 2014
CompletedFirst Posted
Study publicly available on registry
July 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedSeptember 21, 2023
September 1, 2023
1.5 years
July 26, 2014
September 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in insulin sensitivity
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
Secondary Outcomes (5)
Change in blood glucose response to a mixed meal
Baseline and 1 week
Change in hormone secretion response to a mixed meal
Baseline and 1 week
Change in skeletal muscle metabolic flexibility
Baseline and 4 weeks
Change in blood endotoxin levels
Baseline and 4 weeks
Change in gut permeability
Baseline and 4 weeks
Study Arms (2)
Cocoa
EXPERIMENTAL3 servings of polyphenol-rich cocoa beverage consumed per day.
Placebo
PLACEBO COMPARATOR3 servings of non-cocoa beverage consumed per day.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Human Integrative Physiology Laboratory
Blacksburg, Virginia, 24061, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew P Neilson, PhD
Virginia Polytechnic Institute and State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 26, 2014
First Posted
July 29, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2015
Study Completion
May 1, 2016
Last Updated
September 21, 2023
Record last verified: 2023-09