Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Milk Plus Exercise: A Novel Strategy to Treat Diabetes.

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dairy Farmers of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02251301
First received: September 25, 2014
Last updated: August 10, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Type 2 Diabetes
Dietary Supplement: Skim Milk
Behavioral: High intensity interval training
Other: Placebo
Dietary Supplement: Macronutrient isoenergetic control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
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.

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Other Outcome Measures:
  • Change from baseline in fasting plasma non esterified free fatty acid concentration at end of week 12 of intervention. [ Time Frame: Baseline, Week 12 ]
  • Change from baseline in systolic blood pressure at end of week 12 of intervention. [ Time Frame: Baseline, Week 12 ]
  • Change from baseline in diastolic blood pressure at end of week 12 of intervention. [ Time Frame: Baseline, Week 12. ]
  • Change from baseline in circulating inflammatory cytokines at end of week 12 of intervention. [ Time Frame: Baseline, Week 12. ]
  • 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. ]
  • Change from baseline in task switching capabilities at end of week 12 of intervention. [ Time Frame: Baseline, Week 12. ]

Enrollment: 52
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Behavioral: 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.
Dietary Supplement: Macronutrient isoenergetic control
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 Name: Protein
Experimental: 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
Dietary Supplement: Skim 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.
Other Name: Fat-free milk
Behavioral: 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: 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.
Behavioral: 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.
Other: Placebo
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 Name: water

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02251301

Locations
Canada, British Columbia
University of British Columbia, Okanagan.
Kelowna, British Columbia, Canada, V1V 1V7
Sponsors and Collaborators
University of British Columbia
Dairy Farmers of Canada
Investigators
Principal Investigator: Jonathan P Little, PHD University of British Columbia
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02251301     History of Changes
Other Study ID Numbers: H14-01636
Study First Received: September 25, 2014
Last Updated: August 10, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 28, 2017