Overview

This trial is active, not recruiting.

Condition diabetes
Treatments low-fat dairy, sugar-sweetened beverages
Sponsor Provident Clinical Research
Collaborator BioFortis
Start date September 2012
End date September 2013
Trial size 44 participants
Trial identifier NCT01936935, PRV-1222

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
3 servings/d of low-fat dairy
low-fat dairy
2 servings/d of 2% non-flavored, unsweetened milk + 1 serving/d sweetened low-fat yogurt
(Placebo Comparator)
3 servings/d of sugar-sweetened foods
sugar-sweetened beverages
2 servings/d of non-diet soda + 1 serving/d of non-dairy pudding

Primary Outcomes

Measure
Matsuda Insulin Sensitivity Index (MISI)
time frame: 6 weeks

Secondary Outcomes

Measure
Waist circumference
time frame: 6 weeks
Blood pressure
time frame: 6 weeks
Fasting and 2-hr LMTT insulin and glucose concentrations
time frame: 6 weeks
Homeostasis model assessment of insulin resistance (HOMA-IR)
time frame: 6 weeks
Homeostasis model assessment of beta-cell function (HOMA%B)
time frame: 6 weeks
Glucose total area under the curve (AUC) from 0-120 min
time frame: 6 weeks
Insulin total AUC 0-120 min
time frame: 6 weeks
30 min Δ insulin/Δ glucose
time frame: 6 weeks
AUC insulin/AUC glucose
time frame: 6 weeks
Disposition Index
time frame: 6 weeks
Fasting plasma total cholesterol (total-C)
time frame: 6 weeks
Fasting plasma low-density lipoprotein cholesterol (LDL-C)
time frame: 6 weeks
Fasting plasma high-density lipoprotein cholesterol (HDL-C)
time frame: 6 weeks
Fasting plasma total-C/HDL-C
time frame: 6 weeks
Fasting plasma non-HDL-C
time frame: 6 weeks
Fasting plasma TG
time frame: 6 weeks
Serum 25-hydroxy vitamin D [25(OH)D]
time frame: 6 weeks
Plasma high-sensitivity C-reactive protein (hs-CRP)
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 74 years old.

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)

Additional Information

Official title A Randomized, Controlled, Crossover Trial to Assess the Effects of Dairy Intake on Insulin Sensitivity and β-Cell Function in Men and Women at Risk for Diabetes Who Are Habitual Consumers of High Sugar Beverages
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Provident Clinical Research.