Clinical Trial to Assess the Effects of Dairy on Insulin Sensitivity and β-Cell Function

This is an interventional prevention trial for Diabetes focused on measuring Insulin sensitivity Read More

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 vigorous physical activity and consumption of alcoholic beverages 24 h prior to each test day
• subject has no plans to change smoking habits during the study period
• subject is willing to abstain from tobacco use 1 h prior to and during visits on LMTT test days
• subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine lab test results

Exclusion Criteria:

• subject has abnormal lab test results of clinical importance, including, but not limited to, TG ≥400 mg/dL, fasting creatinine ≥1.5 mg/dL, alanine aminotransferase or aspartate aminotransferase ≥1.5 times the upper limit of normal at screening
• subject has a body mass index ≥45.0 kg/m2
• subject has fasting blood glucose ≥126 mg/dL at screening or known diabetes mellitus (type 1 or T2DM)
• subject has a habitual intake of ≥4 servings/d of dairy food and beverages
• subject has known allergy or sensitivity to study product or any ingredients of study product. Subjects with lactose intolerance will be allowed to use products such as Lactaid dietary supplements
• subject has a history of coronary heart disease, congestive heart failure, or serious ventricular dysrhythmias (ventricular tachycardia or fibrillation)
• subject has a change in body weight of >4.5 kg within 4 weeks of screening
• subject uses medications known to influence carbohydrate metabolism
• subject has recent use of antibiotics
• subject has an active infection
• subject has unstable use of anti-hypertensive medications, thyroid hormone replacement, or lipid-altering drugs within 4 weeks of screening
• subject has unstable use of lipid-altering foods or dietary supplements within 4 weeks of screening
• subject uses niacin at doses >200 mg/d within 4 weeks of screening
• subject has history of extreme dietary habits, e.g., Atkins, high protein
• subject has a history or presence of clinically important endocrine, cardiac, renal, hepatic, pulmonary, biliary, pancreatic, gastrointestinal, or neurologic disorders that could interfere with interpretation of study results
• subject has history of dysphagia, swallowing disorders, or intestinal motility disorders
• subject has history of cancer
• subject has uncontrolled hypertension at screening (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg)