Status:
COMPLETED
Cocoa and Metabolic Health in Prediabetes
Lead Sponsor:
Virginia Polytechnic Institute and State University
Collaborating Sponsors:
The Hershey Company
Conditions:
Prediabetes
Eligibility:
All Genders
40-75 years
Phase:
NA
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 hypot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02203240
Start Date
June 1 2014
End Date
May 1 2016
Last Update
September 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Human Integrative Physiology Laboratory
Blacksburg, Virginia, United States, 24061