Clinical Trial to Assess the Effects of Dairy on Insulin Sensitivity and β-Cell Function
- Conditions
- Diabetes
- Interventions
- Other: Sugar-sweetened beveragesOther: Low-fat dairy
- Registration Number
- NCT01936935
- Lead Sponsor
- Provident Clinical Research
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sugar-sweetened beverages Sugar-sweetened beverages 3 servings/d of sugar-sweetened foods Low-fat dairy Low-fat dairy 3 servings/d of low-fat dairy
- Primary Outcome Measures
Name Time Method Matsuda Insulin Sensitivity Index (MISI) 6 weeks MISI calculated from glucose and insulin data obtained during a liquid meal tolerance test (LMTT). MISI = 10,000 divided by the square root of the quantity of fasting glucose x fasting insulin x mean post-load glucose from samples collected at 30, 60, 90 and 120 min after the start of the liquid meal x mean post-load insulin from samples collected at 30, 60, 90 and 120 min after the start of the liquid meal
- Secondary Outcome Measures
Name Time Method Fasting plasma TG 6 weeks Plasma high-sensitivity C-reactive protein (hs-CRP) 6 weeks Blood pressure 6 weeks Standardized vital signs measurements will include resting blood pressure and pulse measured using an automated blood pressure measurement device.
Glucose total area under the curve (AUC) from 0-120 min 6 weeks Glucose total AUC 0-120 min will be calculated using the trapezoidal rule on glucose concentrations in blood samples collected at -10, 30, 60, 90, and 120 min where 0 min is the start of the liquid meal consumption in the LMTT.
Insulin total AUC 0-120 min 6 weeks Insulin total AUC 0-120 min will be calculated using the trapezoidal rule on insulin concentrations in blood samples collected at -10, 30, 60, 90, and 120 min where 0 min is the start of the liquid meal consumption in the LMTT.
30 min Δ insulin/Δ glucose 6 weeks Change in insulin from baseline to 30 min of the LMTT will be divided by the change in glucose from baseline to 30 min of the LMTT
Fasting and 2-hr LMTT insulin and glucose concentrations 6 weeks During the LMTT subjects consume a liquid meal load (two-8 oz servings of Ensure®, Ross Products Division, Abbott Laboratories, Columbus, Ohio), and blood samples will be obtained at t = -10, 30, 60, 90, and 120 min ± 5 min where t = 0 min is the start of meal consumption. Serum insulin and plasma glucose concentrations will be measured in fasting (-10 min) and 2 hr (120 min) samples.
Homeostasis model assessment of insulin resistance (HOMA-IR) 6 weeks HOMA-IR = the quantity of fasting glucose in mg/dL x fasting insulin in microunits/mL divided by 405
Homeostasis model assessment of beta-cell function (HOMA%B) 6 weeks HOMA%B = 360 x fasting insulin in microunits/mL divided by fasting glucose in mg/dL minus 63
Disposition Index 6 weeks Disposition index = MISI x the quantity of AUC for insulin divided by the AUC for glucose
Fasting plasma high-density lipoprotein cholesterol (HDL-C) 6 weeks AUC insulin/AUC glucose 6 weeks AUC for insulin divided by the AUC for glucose
Fasting plasma total cholesterol (total-C) 6 weeks Fasting plasma non-HDL-C 6 weeks Calculated as non-HDL-C = total-C minus HDL-C
Serum 25-hydroxy vitamin D [25(OH)D] 6 weeks Waist circumference 6 weeks Measured using a non-stretch anthropometric tape
Fasting plasma low-density lipoprotein cholesterol (LDL-C) 6 weeks Calculated as LDL-C = total-C minus HDL-C minus the quantity of triglycerides (TG) divided by 5
Fasting plasma total-C/HDL-C 6 weeks Calculated as total-C concentration divided by HDL-C concentration
Trial Locations
- Locations (1)
Provident Clinical Research (now Biofortis)
🇺🇸Addison, Illinois, United States