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

Provident Clinical Research

Status

Completed

Conditions

Diabetes

Treatments

Other: Low-fat dairy

Other: Sugar-sweetened beverages

Study type

Interventional

Funder types

Other

Identifiers

NCT01936935

PRV-1222

Details and patient eligibility

About

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).

Enrollment

44 patients

Sex

All

Ages

18 to 74 years old

Volunteers

Accepts Healthy Volunteers

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)