Clinical trial NCT01936935: Clinical Trial to Assess the Effects of Dairy on Insulin Sensitivity and β-Cell Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Insulin sensitivity
Lead sponsor: Provident Clinical Research
Sponsor class: OTHER
Collaborators: name: BioFortis
name: Dairy Research Institute
First posted: 2013-09-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Matsuda Insulin Sensitivity Index (MISI)
timeFrame: 6 weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: 6 weeks
measure: Blood pressure
timeFrame: 6 weeks
measure: Fasting and 2-hr LMTT insulin and glucose concentrations
timeFrame: 6 weeks
measure: Homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: 6 weeks
measure: Homeostasis model assessment of beta-cell function (HOMA%B)
timeFrame: 6 weeks
measure: Glucose total area under the curve (AUC) from 0-120 min
timeFrame: 6 weeks
measure: Insulin total AUC 0-120 min
timeFrame: 6 weeks
measure: 30 min Δ insulin/Δ glucose
timeFrame: 6 weeks
measure: AUC insulin/AUC glucose
timeFrame: 6 weeks
measure: Disposition Index
timeFrame: 6 weeks
measure: Fasting plasma total cholesterol (total-C)
timeFrame: 6 weeks
measure: Fasting plasma low-density lipoprotein cholesterol (LDL-C)
timeFrame: 6 weeks
measure: Fasting plasma high-density lipoprotein cholesterol (HDL-C)
timeFrame: 6 weeks
measure: Fasting plasma total-C/HDL-C
timeFrame: 6 weeks
measure: Fasting plasma non-HDL-C
timeFrame: 6 weeks
measure: Fasting plasma TG
timeFrame: 6 weeks
measure: Serum 25-hydroxy vitamin D [25(OH)D]
timeFrame: 6 weeks
measure: Plasma high-sensitivity C-reactive protein (hs-CRP)
timeFrame: 6 weeks
Other outcomes:
measure: Mean circulating glucose level
timeFrame: 6 weeks
measure: Mean daytime glucose values
timeFrame: 6 weeks
measure: Mean evening/nighttime glucose values
timeFrame: 6 weeks
measure: Mean peak postprandial glucose
timeFrame: 6 weeks
Locations:
city: Addison
country: United States
facility: Provident Clinical Research (now Biofortis)
state: Illinois
Study officials:
affiliation: Biofortis Clinical Research, Inc.
name: Kevin C Maki, PhD
role: STUDY_DIRECTOR
References:
citation: Maki KC, Nieman KM, Schild AL, Kaden VN, Lawless AL, Kelley KM, Rains TM. Sugar-sweetened product consumption alters glucose homeostasis compared with dairy product consumption in men and women at risk of type 2 diabetes mellitus. J Nutr. 2015 Mar;145(3):459-66. doi: 10.3945/jn.114.204503. Epub 2015 Jan 7.