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Completed

NCT Number: NCT02251301

Milk Plus Exercise: A Novel Strategy to Treat Diabetes.

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skim Milk

Dietary Supplement

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

High Intensity Interval Training

Behavioral

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

Other

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

Macronutrient isoenergetic control

Dietary Supplement

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

Primary outcomes

  1. 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

  1. Change from baseline in hemoglobin A1C percentage at end of week 12 of intervention.

    Time frame: Baseline, Week 12.

  2. Change from baseline in fasting plasma glucose concentration at end of week 12 of intervention.

    Time frame: Baseline, Week 12.

  3. Change from baseline in fasting plasma insulin concentration at end of week 12 of intervention.

    Time frame: Baseline, Week 12.

  4. Change from baseline in flow mediated dilation of brachial artery at end of week 12 of intervention.

    Time frame: Baseline, Week 12.

  5. 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 outcomes

  1. Change from baseline in fasting plasma non esterified free fatty acid concentration at end of week 12 of intervention.

    Time frame: Baseline, Week 12

  2. Change from baseline in systolic blood pressure at end of week 12 of intervention.

    Time frame: Baseline, Week 12

  3. Change from baseline in diastolic blood pressure at end of week 12 of intervention.

    Time frame: Baseline, Week 12.

  4. Change from baseline in circulating inflammatory cytokines at end of week 12 of intervention.

    Time frame: Baseline, Week 12.

  5. 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.

  6. Change from baseline in task switching capabilities at end of week 12 of intervention.

    Time frame: Baseline, Week 12.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Dairy Farmers of Canada

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 29, 2014
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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