Clinical trial NCT02203240: Cocoa and Metabolic Health in Prediabetes
Official title: Dietary Cocoa for Inhibition of Metabolic Endotoxemia and Glucose Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Keywords: Cacao
Polyphenols
Prediabetic State
Blood Glucose
Glucose Intolerance
Diabetes Mellitus, Type 2
Obesity
Muscle, Skeletal
Endotoxins
Gut Permeability
Incretins
Metabolic Flexibility
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: The Hershey Company
First posted: 2014-07-29
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in insulin sensitivity
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in blood glucose response to a mixed meal
timeFrame: Baseline and 1 week
measure: Change in hormone secretion response to a mixed meal
timeFrame: Baseline and 1 week
measure: Change in skeletal muscle metabolic flexibility
timeFrame: Baseline and 4 weeks
measure: Change in blood endotoxin levels
timeFrame: Baseline and 4 weeks
measure: Change in gut permeability
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Human Integrative Physiology Laboratory
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Andrew P Neilson, PhD
role: PRINCIPAL_INVESTIGATOR
References: