Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments skim milk, high intensity interval training, placebo, macronutrient isoenergetic control
Sponsor University of British Columbia
Collaborator Dairy Farmers of Canada
Start date January 2015
End date January 2017
Trial size 52 participants
Trial identifier NCT02251301, H14-01636

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Active Comparator)
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
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.
macronutrient isoenergetic control Protein
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.
(Experimental)
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
skim milk Fat-free 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.
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.
(Placebo Comparator)
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.
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.
placebo water
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.

Primary Outcomes

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

Secondary Outcomes

Measure
Change from baseline in hemoglobin A1C percentage at end of week 12 of intervention.
time frame: Baseline, Week 12.
Change from baseline in fasting plasma glucose concentration at end of week 12 of intervention.
time frame: Baseline, Week 12.
Change from baseline in fasting plasma insulin concentration at end of week 12 of intervention.
time frame: 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.
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

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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

Additional Information

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.
Principal investigator Jonathan P Little, PHD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.