Cocoa and Metabolic Health in Prediabetes

Virginia Polytechnic Institute and State University

Status

Completed

Conditions

Prediabetes

Treatments

Other: Cocoa

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02203240

VT13261005

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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