Type 2 DiabetesNCT02251301
Milk Plus Exercise: A Novel Strategy to Treat Diabetes.
A study testing Skim Milk and High intensity interval training in people with Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Skim Milk and High intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40 and 75.
- Diagnosed with type 2 diabetes for more than 6 months.
- On stable medication for the last 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Okanagan.
Kelowna, British Columbia, V1V 1V7
About this study
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.
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Skim Milk, High intensity interval training, Placebo, Macronutrient isoenergetic control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skim MilkDietary supplement
Also called Fat-free 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.
High intensity interval trainingBehavioural
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.
PlaceboOther
Also called water
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.
Macronutrient isoenergetic controlDietary supplement
Also called Protein
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: High intensity interval training; Dietary 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 Receives: Dietary Supplement: Skim Milk; Behavioral: 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. Receives: Behavioral: High intensity interval training; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention
Measured: Baseline, Week 12.
Secondary outcomes (5)
Change from baseline in hemoglobin A1C percentage at end of week 12 of intervention.
Measured: Baseline, Week 12.
Change from baseline in fasting plasma glucose concentration at end of week 12 of intervention.
Measured: Baseline, Week 12.
Change from baseline in fasting plasma insulin concentration at end of week 12 of intervention.
Measured: Baseline, Week 12.
Change from baseline in flow mediated dilation of brachial artery at end of week 12 of intervention.
Measured: Baseline, Week 12.
Change from baseline in peak oxygen uptake as a measure of aerobic fitness at end of week 12 of intervention.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Responsible party
- Sponsor
- Investigators
- Jonathan P Little, PHD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251301
- Sponsor's protocol ID
- H14-01636
- Status last verified
- Aug 2016
- First submitted
- 25 Sep 2014
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29198993
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02251301
- Acronym / sponsor ID
- H14-01636
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Macronutrient isoenergetic control | Active comparator | Behavioral: High intensity interval training, Dietary Supplement: Macronutrient isoenergetic controlParticipants 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 |
| Skim Milk | Experimental | Dietary Supplement: Skim Milk, Behavioral: High intensity interval trainingParticipants 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 |
| Placebo | Placebo comparator | Behavioral: High intensity interval training, Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 40 and 75.
- Diagnosed with type 2 diabetes for more than 6 months.
- On stable medication for the last 6 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skim MilkAlso: Fat-free milk250 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. | Dietary supplement | Skim Milk |
| High intensity interval trainingAll 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. | Behavioural | Macronutrient isoenergetic control, Placebo, Skim Milk |
| PlaceboAlso: water250 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 | Placebo |
| Macronutrient isoenergetic controlAlso: Protein250 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. | Dietary supplement | Macronutrient isoenergetic control |
Primary outcome
Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention
Time frame: Baseline, Week 12.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Derived from this study: PubMed 29198993Francois 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan P Little, PHD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skim Milk and High intensity interval training in people with Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in glycemic control assessed by continuous glucose monitoring at end of week 12 of intervention (time frame: Baseline, Week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02251301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.