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Milk Plus Exercise: A Novel Strategy to Treat Diabetes.

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Skim Milk
High intensity interval training
Placebo
Macronutrient isoenergetic control
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British Columbia, Okanagan.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Macronutrient isoenergetic control

Skim Milk

Placebo

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2014
Last Updated
May 1, 2017
Sponsor
University of British Columbia
Collaborators
Dairy Farmers of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02251301
Brief Title
Milk Plus Exercise: A Novel Strategy to Treat Diabetes.
Official Title
The Effect of Adding Milk in Proximity to Exercise During an Interval Training Intervention in Type 2 Diabetes (T2D) on Metabolic and Cardiovascular Health.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Dairy Farmers of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macronutrient isoenergetic control
Arm Type
Active Comparator
Arm Description
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
Arm Title
Skim Milk
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Skim Milk
Other Intervention Name(s)
Fat-free milk
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
water
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Macronutrient isoenergetic control
Other Intervention Name(s)
Protein
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention
Time Frame
Baseline, Week 12.
Secondary Outcome Measure Information:
Title
Change from baseline in hemoglobin A1C percentage at end of week 12 of intervention.
Time Frame
Baseline, Week 12.
Title
Change from baseline in fasting plasma glucose concentration at end of week 12 of intervention.
Time Frame
Baseline, Week 12.
Title
Change from baseline in fasting plasma insulin concentration at end of week 12 of intervention.
Time Frame
Baseline, Week 12.
Title
Change from baseline in flow mediated dilation of brachial artery at end of week 12 of intervention.
Time Frame
Baseline, Week 12.
Title
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
Other Pre-specified Outcome Measures:
Title
Change from baseline in fasting plasma non esterified free fatty acid concentration at end of week 12 of intervention.
Time Frame
Baseline, Week 12
Title
Change from baseline in systolic blood pressure at end of week 12 of intervention.
Time Frame
Baseline, Week 12
Title
Change from baseline in diastolic blood pressure at end of week 12 of intervention.
Time Frame
Baseline, Week 12.
Title
Change from baseline in circulating inflammatory cytokines at end of week 12 of intervention.
Time Frame
Baseline, Week 12.
Title
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.
Title
Change from baseline in task switching capabilities at end of week 12 of intervention.
Time Frame
Baseline, Week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Little, PHD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia, Okanagan.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29198993
Citation
Francois ME, Pistawka KJ, Halperin FA, Little JP. Cardiovascular benefits of combined interval training and post-exercise nutrition in type 2 diabetes. J Diabetes Complications. 2018 Feb;32(2):226-233. doi: 10.1016/j.jdiacomp.2017.10.002. Epub 2017 Nov 29.
Results Reference
derived

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Milk Plus Exercise: A Novel Strategy to Treat Diabetes.

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