NCT02251301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 2, 2017

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

September 25, 2014

Last Update Submit

May 1, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention

    Baseline, Week 12.

Secondary Outcomes (5)

  • 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

Other Outcomes (6)

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

    Baseline, Week 12

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

    Baseline, Week 12

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

    Baseline, Week 12.

  • +3 more other outcomes

Study Arms (3)

Macronutrient isoenergetic control

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

Behavioral: High intensity interval trainingDietary Supplement: Macronutrient isoenergetic control

Skim Milk

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

Dietary Supplement: Skim MilkBehavioral: High intensity interval training

Placebo

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.

Behavioral: High intensity interval trainingOther: Placebo

Interventions

Skim MilkDIETARY_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.

Also known as: Fat-free milk
Skim Milk
High intensity interval trainingBEHAVIORAL

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 controlPlaceboSkim Milk
PlaceboOTHER

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.

Also known as: water
Placebo
Macronutrient isoenergetic controlDIETARY_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.

Also known as: Protein
Macronutrient isoenergetic control

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 40 and 75.
  • Diagnosed with type 2 diabetes for more than 6 months.
  • On stable medication for the last 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (1)

  • Francois ME, Pistawka KJ, Halperin FA, Little JP. Cardiovascular benefits of combined interval training and post-exercise nutrition in type 2 diabetes. J Diabetes Complications. 2018 Feb;32(2):226-233. doi: 10.1016/j.jdiacomp.2017.10.002. Epub 2017 Nov 29.

    PMID: 29198993DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

High-Intensity Interval TrainingWaterProteins

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsAmino Acids, Peptides, and Proteins

Study Officials

  • Jonathan P Little, PHD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

September 29, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 2, 2017

Record last verified: 2016-08

Locations

CA(1)