Diabetes
Conditions
Keywords
Insulin sensitivity
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).
Interventions
OTHERLow-fat dairy
2 servings/d of 2% non-flavored, unsweetened milk + 1 serving/d sweetened low-fat yogurt
2 servings/d of non-diet soda + 1 serving/d of non-dairy pudding
Sponsors
BioFortis
Dairy Research Institute
Provident Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum 25-hydroxy vitamin D [25(OH)D] | 6 weeks | — |
| 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 |
| 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. |
| Disposition Index | 6 weeks | Disposition index = MISI x the quantity of AUC for insulin divided by the AUC for glucose |
| Fasting plasma total cholesterol (total-C) | 6 weeks | — |
| 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 high-density lipoprotein cholesterol (HDL-C) | 6 weeks | — |
| Fasting plasma total-C/HDL-C | 6 weeks | Calculated as total-C concentration divided by HDL-C concentration |
| Fasting plasma non-HDL-C | 6 weeks | Calculated as non-HDL-C = total-C minus HDL-C |
| Fasting plasma TG | 6 weeks | — |
| Plasma high-sensitivity C-reactive protein (hs-CRP) | 6 weeks | — |
| 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 |
| AUC insulin/AUC glucose | 6 weeks | AUC for insulin divided by the AUC for glucose |
| Waist circumference | 6 weeks | Measured using a non-stretch anthropometric tape |
| Blood pressure | 6 weeks | Standardized vital signs measurements will include resting blood pressure and pulse measured using an automated blood pressure measurement device. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean evening/nighttime glucose values | 6 weeks | Mean evening/nighttime glucose values (8 pm to 6 am) measured in the CGM subset of subjects |
| Mean peak postprandial glucose | 6 weeks | Mean peak postprandial glucose values during CGM after the lunch and dinner meals |
| Mean daytime glucose values | 6 weeks | Mean daytime glucose values (6 am to 8 pm) measured in the CGM subset of subjects |
| Mean circulating glucose level | 6 weeks | Mean circulating glucose level will be measured over 24 h in the continuous glucose monitoring (CGM) subset of subjects |
Countries
United States
Outcome results
None listed