Milk Plus Exercise: A Novel Strategy to Treat Diabetes.

May 1, 2017 updated by: University of British Columbia

The Effect of Adding Milk in Proximity to Exercise During an Interval Training Intervention in Type 2 Diabetes (T2D) on Metabolic and Cardiovascular Health.

The purpose of this study is to investigate whether combining interval training with skim milk supplementation will result in improved glucose control and markers of cardiovascular health in people with type 2 diabetes. Participants will complete supervised interval training three times a week over a 12 week training period while consuming skim-milk, whey/casein protein drink, or a placebo beverage that does not contain any calories or vitamins/minerals immediately and 1 hour after each training session. After twelve weeks participants will repeat baseline tests to examine any effects of the intervention on their glucose control, fitness, blood vessel function, body composition, and blood markers of inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • 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

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 1V7
        • University of British Columbia, Okanagan.

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

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 40 and 75.
  • Diagnosed with type 2 diabetes for more than 6 months.
  • On stable medication for the last 6 months

Exclusion Criteria:

  • Type 2 diabetes controlled with exogenous insulin
  • Uncontrolled hypertension (blood pressure >160/90 mmHg)
  • History of heart disease, myocardial infarction or stroke
  • Any other contraindications to exercise

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Macronutrient isoenergetic control
Participants will also engage in twelve weeks of high intensity interval training with consumption of one serving (250 mL) of macro nutrient matched isoenergetic control (whey/casein protein and dextrose/lactose) consumed immediately and 1 h after each training session
Behavioral: High intensity interval training
All participants will undergo a 12 week high intensity interval training program consisting of 3 supervised sessions a week of 4-10 x 1 min high intensity interval alternating with 1 min of recovery.
Dietary supplement: Macronutrient isoenergetic control
250 mL of protein+cho matched drink will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
Other Names:
  • Protein
Experimental: Skim Milk
Participants will also engage in twelve weeks of High intensity interval training with consumption of one serving (250 mL) of fat-free fluid milk immediately and 1 h after each training session
Behavioral: High intensity interval training
All participants will undergo a 12 week high intensity interval training program consisting of 3 supervised sessions a week of 4-10 x 1 min high intensity interval alternating with 1 min of recovery.
Dietary supplement: Skim Milk
250 ml skim milk will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
Other Names:
  • Fat-free milk
Placebo Comparator: Placebo
Participants will also engage in twelve weeks of high intensity interval training with consumption of one serving (250 mL) of placebo (water) consumed immediately and 1 h after each training session.
Behavioral: High intensity interval training
All participants will undergo a 12 week high intensity interval training program consisting of 3 supervised sessions a week of 4-10 x 1 min high intensity interval alternating with 1 min of recovery.
Other: Placebo
250 mL water will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
Other Names:
  • water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention
Time Frame: Baseline, Week 12.
Baseline, Week 12.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in hemoglobin A1C percentage at end of week 12 of intervention.
Time Frame: Baseline, Week 12.
Baseline, Week 12.
Change from baseline in fasting plasma glucose concentration at end of week 12 of intervention.
Time Frame: Baseline, Week 12.
Baseline, Week 12.
Change from baseline in fasting plasma insulin concentration at end of week 12 of intervention.
Time Frame: Baseline, Week 12.
Baseline, Week 12.
Change from baseline in flow mediated dilation of brachial artery at end of week 12 of intervention.
Time Frame: Baseline, Week 12.
Baseline, Week 12.
Change from baseline in peak oxygen uptake as a measure of aerobic fitness at end of week 12 of intervention.
Time Frame: Baseline, Week 12
Baseline, Week 12

Other Outcome Measures

Outcome Measure
Time Frame
Change from baseline in fasting plasma non esterified free fatty acid concentration at end of week 12 of intervention.
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from baseline in systolic blood pressure at end of week 12 of intervention.
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from baseline in diastolic blood pressure at end of week 12 of intervention.
Time Frame: Baseline, Week 12.
Baseline, Week 12.
Change from baseline in circulating inflammatory cytokines at end of week 12 of intervention.
Time Frame: Baseline, Week 12.
Baseline, Week 12.
Change from baseline in body composition as measured by dual absorbancy x ray at end of week 12 of intervention.
Time Frame: Baseline, Week 12.
Baseline, Week 12.
Change from baseline in task switching capabilities at end of week 12 of intervention.
Time Frame: Baseline, Week 12.
Baseline, Week 12.

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

Dairy Farmers of Canada

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

January 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-01636

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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