Milk Plus Exercise: A Novel Strategy to Treat Diabetes.

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Skim Milk
* Behavioral: High intensity interval training
* Other: Placebo
* Dietary Supplement: Macronutrient isoenergetic control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Macronutrient isoenergetic control<br>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<br>* 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.<br>Dietary Supplement: Macronutrient isoenergetic control<br>* 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.<br>* Other names: Protein;|
| Experimental: Skim Milk<br>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 | Dietary Supplement: Skim Milk<br>* 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.<br>* Other names: Fat-free milk;Behavioral: High intensity interval training<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>Other: Placebo<br>* 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.<br>* Other names: water;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |