Cocoa and Metabolic Health in Prediabetes
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 10/3/2018 |
| Start Date: | June 2014 |
| End Date: | May 2016 |
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.
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.
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
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