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

November 28, 2023 updated by: Provident Clinical Research

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Addison, Illinois, United States, 60101
        • Provident Clinical Research (now Biofortis)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: 6 weeks
Measured using a non-stretch anthropometric tape
6 weeks
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.
6 weeks
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.
6 weeks
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
6 weeks
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 weeks
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.
6 weeks
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.
6 weeks
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
6 weeks
AUC insulin/AUC glucose
Time Frame: 6 weeks
AUC for insulin divided by the AUC for glucose
6 weeks
Disposition Index
Time Frame: 6 weeks
Disposition index = MISI x the quantity of AUC for insulin divided by the AUC for glucose
6 weeks
Fasting plasma total cholesterol (total-C)
Time Frame: 6 weeks
6 weeks
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
6 weeks
Fasting plasma high-density lipoprotein cholesterol (HDL-C)
Time Frame: 6 weeks
6 weeks
Fasting plasma total-C/HDL-C
Time Frame: 6 weeks
Calculated as total-C concentration divided by HDL-C concentration
6 weeks
Fasting plasma non-HDL-C
Time Frame: 6 weeks
Calculated as non-HDL-C = total-C minus HDL-C
6 weeks
Fasting plasma TG
Time Frame: 6 weeks
6 weeks
Serum 25-hydroxy vitamin D [25(OH)D]
Time Frame: 6 weeks
6 weeks
Plasma high-sensitivity C-reactive protein (hs-CRP)
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 weeks
Mean daytime glucose values
Time Frame: 6 weeks
Mean daytime glucose values (6 am to 8 pm) measured in the CGM subset of subjects
6 weeks
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
6 weeks
Mean peak postprandial glucose
Time Frame: 6 weeks
Mean peak postprandial glucose values during CGM after the lunch and dinner meals
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Provident Clinical Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioFortis
Dairy Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kevin C Maki, PhD, Biofortis Clinical Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRV-1222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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