Clinical Trial to Assess the Effects of Dairy on Insulin Sensitivity and β-Cell Function (NCT01936935) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Assess the Effects of Dairy on Insulin Sensitivity and β-Cell Function
United States44 participantsStarted 2012-09
Plain-language summary
The aim of this trial is to evaluate the effects of dairy product consumption on insulin sensitivity and pancreatic β-cell function in men and women at risk for the development of type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet sodas and fruit juice cocktails).
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion Criteria:
* subject is male or female, 18-74 yrs of age, inclusive
* subject reports habitual consumption of ≥2 servings/d of high-sugar beverages (e.g., non-diet soda, fruit juice cocktails)
* subject has waist circumference ≥33.0 inches for women and ≥36.0 inches for men
* subject is at risk for development of type 2 diabetes mellitus (T2DM), based on 1 or more of the following: fasting glucose 100-125 mg/dL; glycosylated hemoglobin 5.7-6.4%, or ≥20% risk of developing diabetes in the next 7.5 yrs based on the San Antonio Heart Study prediction equation
* subject has a score of 7-10 on the Vein Access Scale at screening
* subject is normally active and judged to be in good health on the basis of medical history, physical examination and routine lab tests
* if female, subject is willing to schedule treatment visits during the follicular phase of the menstrual cycle, defined as days 1-14, where day 1 is 1st day of menses
* subject has a menstrual cycle duration ranging in length form 24-36 d (if premenopausal)
* subject is willing to maintain a stable body weight and follow his/her habitual diet and exercise pattern, except for inclusion of study product, throughout the trial
* subject is willing to maintain his or her habitual intake of coffee, tea, and alcoholic beverages throughout the trial
* subject agrees to limit intake of non-study related dairy products to ≤1 serving per day during each treatment period
* subject is ambulatory and willing to refrain from v…