Milk Plus Exercise: A Novel Strategy to Treat Diabetes.

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Skim Milk; Dietary Supplement: Macronutrient isoenergetic control; Behavioral: High intensity interval training; Other: Placebo

• Registration Number: NCT02251301
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-29
• Study Start: 2015-01
• Status Verified: 2016-08
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macronutrient isoenergetic control	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
Skim Milk	High intensity interval training	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
Macronutrient isoenergetic control	High intensity interval training	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
Placebo	High intensity interval training	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.
Placebo	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.
Skim Milk	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

Primary Outcome Measures

Name	Time	Method
Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention	Baseline, Week 12.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of British Columbia, Okanagan.; 🇨🇦 Kelowna, British Columbia, Canada