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

NCT01936935 | Completed

• 1 other identifier: PRV-1222
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes

Keywords

Insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Waist circumference

  6 weeks

• Blood pressure

  6 weeks

• Fasting and 2-hr LMTT insulin and glucose concentrations

  6 weeks

• Homeostasis model assessment of insulin resistance (HOMA-IR)

  6 weeks

• Homeostasis model assessment of beta-cell function (HOMA%B)

  6 weeks

Other Outcomes (4)

• Mean circulating glucose level

  6 weeks

• Mean daytime glucose values

  6 weeks

• Mean evening/nighttime glucose values

  6 weeks

Study Arms (2)

Low-fat dairy

EXPERIMENTAL

3 servings/d of low-fat dairy

Other: Low-fat dairy

Sugar-sweetened beverages

PLACEBO COMPARATOR

3 servings/d of sugar-sweetened foods

Other: Sugar-sweetened beverages

Interventions

Low-fat dairy OTHER

2 servings/d of 2% non-flavored, unsweetened milk + 1 serving/d sweetened low-fat yogurt

Low-fat dairy

Sugar-sweetened beverages OTHER

2 servings/d of non-diet soda + 1 serving/d of non-dairy pudding

Sugar-sweetened beverages

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Provident Clinical Research: lead
• BioFortis: collaborator
• Dairy Research Institute: collaborator

Study Sites (1)

Provident Clinical Research (now Biofortis)

Addison, Illinois, 60101, United States

Location

Related Publications (1)

• 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.

  PMID: 25733460 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

Sugar-Sweetened Beverages

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kevin C Maki, PhD

  Biofortis Clinical Research, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 4, 2023

Record last verified: 2013-09

Locations

US (1)