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

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ClinicalTrials.gov Identifier: NCT01936935
Recruitment Status : Unknown
Verified September 2013 by Provident Clinical Research.
Recruitment status was:  Active, not recruiting
First Posted : September 6, 2013
Last Update Posted : September 6, 2013
Sponsor:
Collaborators:
BioFortis
Dairy Research Institute
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Diabetes Other: Low-fat dairy Other: Sugar-sweetened beverages Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Low-fat dairy
3 servings/d of low-fat dairy
Other: Low-fat dairy
2 servings/d of 2% non-flavored, unsweetened milk + 1 serving/d sweetened low-fat yogurt

Placebo Comparator: Sugar-sweetened beverages
3 servings/d of sugar-sweetened foods
Other: Sugar-sweetened beverages
2 servings/d of non-diet soda + 1 serving/d of non-dairy pudding




Primary Outcome Measures :
  1. Matsuda Insulin Sensitivity Index (MISI) [ Time Frame: 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 :
  1. Waist circumference [ Time Frame: 6 weeks ]
    Measured using a non-stretch anthropometric tape

  2. Blood pressure [ Time Frame: 6 weeks ]
    Standardized vital signs measurements will include resting blood pressure and pulse measured using an automated blood pressure measurement device.

  3. Fasting and 2-hr LMTT insulin and glucose concentrations [ Time Frame: 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.

  4. Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 6 weeks ]
    HOMA-IR = the quantity of fasting glucose in mg/dL x fasting insulin in microunits/mL divided by 405

  5. Homeostasis model assessment of beta-cell function (HOMA%B) [ Time Frame: 6 weeks ]
    HOMA%B = 360 x fasting insulin in microunits/mL divided by fasting glucose in mg/dL minus 63

  6. Glucose total area under the curve (AUC) from 0-120 min [ Time Frame: 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.

  7. Insulin total AUC 0-120 min [ Time Frame: 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.

  8. 30 min Δ insulin/Δ glucose [ Time Frame: 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

  9. AUC insulin/AUC glucose [ Time Frame: 6 weeks ]
    AUC for insulin divided by the AUC for glucose

  10. Disposition Index [ Time Frame: 6 weeks ]
    Disposition index = MISI x the quantity of AUC for insulin divided by the AUC for glucose

  11. Fasting plasma total cholesterol (total-C) [ Time Frame: 6 weeks ]
  12. Fasting plasma low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 6 weeks ]
    Calculated as LDL-C = total-C minus HDL-C minus the quantity of triglycerides (TG) divided by 5

  13. Fasting plasma high-density lipoprotein cholesterol (HDL-C) [ Time Frame: 6 weeks ]
  14. Fasting plasma total-C/HDL-C [ Time Frame: 6 weeks ]
    Calculated as total-C concentration divided by HDL-C concentration

  15. Fasting plasma non-HDL-C [ Time Frame: 6 weeks ]
    Calculated as non-HDL-C = total-C minus HDL-C

  16. Fasting plasma TG [ Time Frame: 6 weeks ]
  17. Serum 25-hydroxy vitamin D [25(OH)D] [ Time Frame: 6 weeks ]
  18. Plasma high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: 6 weeks ]

Other Outcome Measures:
  1. Mean circulating glucose level [ Time Frame: 6 weeks ]
    Mean circulating glucose level will be measured over 24 h in the continuous glucose monitoring (CGM) subset of subjects

  2. Mean daytime glucose values [ Time Frame: 6 weeks ]
    Mean daytime glucose values (6 am to 8 pm) measured in the CGM subset of subjects

  3. Mean evening/nighttime glucose values [ Time Frame: 6 weeks ]
    Mean evening/nighttime glucose values (8 pm to 6 am) measured in the CGM subset of subjects

  4. Mean peak postprandial glucose [ Time Frame: 6 weeks ]
    Mean peak postprandial glucose values during CGM after the lunch and dinner meals



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936935


Locations
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United States, Illinois
Provident Clinical Research (now Biofortis)
Addison, Illinois, United States, 60101
Sponsors and Collaborators
Provident Clinical Research
BioFortis
Dairy Research Institute
Investigators
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Study Director: Kevin C Maki, PhD Biofortis Clinical Research, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Provident Clinical Research
ClinicalTrials.gov Identifier: NCT01936935    
Other Study ID Numbers: PRV-1222
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013
Keywords provided by Provident Clinical Research:
Insulin sensitivity
Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases