Milk Plus Exercise: A Novel Strategy to Treat Diabetes.

NCT ID: NCT02251301

Last Updated: 2017-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-01-31

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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

High intensity interval training

Intervention Type 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.

Macronutrient isoenergetic control

Intervention Type 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.

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

Group Type EXPERIMENTAL

Skim Milk

Intervention Type 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.

High intensity interval training

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

High intensity interval training

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fat-free milk water Protein

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dairy Farmers of Canada

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan P Little, PHD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia, Okanagan.

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 29198993 (View on PubMed)

Other Identifiers

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H14-01636

Identifier Type: -

Identifier Source: org_study_id

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