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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936935
• Other study ID #: PRV-1222
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Provident Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Hypersensitivity
• Insulin Resistance

Intervention

Other:
• Low-fat dairy
2 servings/d of 2% non-flavored, unsweetened milk + 1 serving/d sweetened low-fat yogurt
• Sugar-sweetened beverages
2 servings/d of non-diet soda + 1 serving/d of non-dairy pudding

Locations

Country	Name	City	State
United States	Provident Clinical Research (now Biofortis)	Addison	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Provident Clinical Research	BioFortis, Dairy Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean circulating glucose level	Mean circulating glucose level will be measured over 24 h in the continuous glucose monitoring (CGM) subset of subjects	6 weeks
Other	Mean daytime glucose values	Mean daytime glucose values (6 am to 8 pm) measured in the CGM subset of subjects	6 weeks
Other	Mean evening/nighttime glucose values	Mean evening/nighttime glucose values (8 pm to 6 am) measured in the CGM subset of subjects	6 weeks
Other	Mean peak postprandial glucose	Mean peak postprandial glucose values during CGM after the lunch and dinner meals	6 weeks
Primary	Matsuda Insulin Sensitivity Index (MISI)	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	6 weeks
Secondary	Waist circumference	Measured using a non-stretch anthropometric tape	6 weeks
Secondary	Blood pressure	Standardized vital signs measurements will include resting blood pressure and pulse measured using an automated blood pressure measurement device.	6 weeks
Secondary	Fasting and 2-hr LMTT insulin and glucose concentrations	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.	6 weeks
Secondary	Homeostasis model assessment of insulin resistance (HOMA-IR)	HOMA-IR = the quantity of fasting glucose in mg/dL x fasting insulin in microunits/mL divided by 405	6 weeks
Secondary	Homeostasis model assessment of beta-cell function (HOMA%B)	HOMA%B = 360 x fasting insulin in microunits/mL divided by fasting glucose in mg/dL minus 63	6 weeks
Secondary	Glucose total area under the curve (AUC) from 0-120 min	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.	6 weeks
Secondary	Insulin total AUC 0-120 min	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.	6 weeks
Secondary	30 min ? insulin/? glucose	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	6 weeks
Secondary	AUC insulin/AUC glucose	AUC for insulin divided by the AUC for glucose	6 weeks
Secondary	Disposition Index	Disposition index = MISI x the quantity of AUC for insulin divided by the AUC for glucose	6 weeks
Secondary	Fasting plasma total cholesterol (total-C)		6 weeks
Secondary	Fasting plasma low-density lipoprotein cholesterol (LDL-C)	Calculated as LDL-C = total-C minus HDL-C minus the quantity of triglycerides (TG) divided by 5	6 weeks
Secondary	Fasting plasma high-density lipoprotein cholesterol (HDL-C)		6 weeks
Secondary	Fasting plasma total-C/HDL-C	Calculated as total-C concentration divided by HDL-C concentration	6 weeks
Secondary	Fasting plasma non-HDL-C	Calculated as non-HDL-C = total-C minus HDL-C	6 weeks
Secondary	Fasting plasma TG		6 weeks
Secondary	Serum 25-hydroxy vitamin D [25(OH)D]		6 weeks
Secondary	Plasma high-sensitivity C-reactive protein (hs-CRP)		6 weeks