ClinicalTrials.gg
Not yet recruitingNCT07513987Updated Apr 7, 2026

IMPACT: Immune and Musculoskeletal Physiological Adaptations to Combined Exercise Training & Nutrition

An interventional study of Milk and Greek Yogurt in Overweight (BMI > 25) and Males and Females, sponsored by York University. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by York University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether 12 weeks of exercise training combined with dairy consumption influences inflammation and immune responses in adults with overweight, compared to exercise training alone.

Read the detailed description

Individuals with overweight often have higher levels of inflammation, which can increase the risk of developing many health conditions. As adults with overweight represent a growing proportion of the Canadian population, research that emphasizes lifestyle interventions to help manage inflammation is warranted. Our proposed research combines both exercise and nutritional interventions along with detailed assessment of inflammation and immune responses in adults with overweight. This study aims to determine whether different dairy products can positively influence inflammation and immune function when consumed during a structured exercise training program.

Exercise training is known to reduce inflammation, and these positive effects may be bolstered by nutritional strategies, particularly through the consumption of dairy products. Dairy products such as milk and Greek yogurt (GY) are widely accessible, nutrient-dense foods, that contain anti-inflammatory constituents that may reduce systemic inflammation. Indeed, the chronic consumption of dairy in adults with overweight has been shown to reduce inflammatory and increase in anti-inflammatory markers, in the absence of exercise training. Importantly, GY and milk may have differential effects on inflammation due to differences in their preparation and constitution. GY is a fermented dairy product with bacterial cultures that may influence the gut, whereas milk is fortified with vitamin D, which most GY in Canada lacks. With respect to exercise, new and (currently) unpublished work from our group has demonstrated some differences in the acute inflammatory response to a single exercise bout following milk or GY consumption. Yet, longer-term exercise training studies with nutrition interventions, particularly ones that explore different dairy products, are seldom designed with inflammation as the primary outcome. Moreover, most studies assess inflammation only using circulating markers and do not examine dynamic responses such as how immune cells themselves adapt over time.

Rationale: Our study will help determine whether consuming different dairy products during a structured exercise training program influences inflammation and adaptations in immune responses in adults with overweight. Evidence exists for: 1) the role of exercise training in reducing inflammation in humans and inducing anti-inflammatory adaptions in immune cells in animal models, and 2) the effects of chronic dairy consumption on modulating inflammatory markers at rest. By comparing exercise training combined with milk consumption, exercise training with GY consumption, and exercise training with a habitually low-dairy diet, this study will assess whether the chronic consumption of different dairy products differentially modulate the effects of exercise training on comprehensive measures of inflammation and immune responses.

02

Conditions studied

  • Overweight (BMI > 25)
  • Males and Females

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03

In context

Overweight

3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.

This study's planned enrollment of 60 is below the median of 78 across 3,120 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

York University is the lead sponsor of 51 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Between the ages of 18 and 50 years
  • Overweight (25.0-29.9) kg/m2
  • 'Overweight' body fat percentage (males: ≤30%; females: ≤42%)
  • Low to moderately physically active (0-2 times/week)
  • Habitual low dairy consumption (≤ 1 serving/day, assessed via baseline food record)

Exclusion criteria

Exclusion Criteria:

  • Peri- or status (female)
  • Dairy protein allergy or lactose intolerance
  • Use of vitamin D and/or calcium supplements
  • Any musculoskeletal, , or inflammatory conditions
  • Use of medication related to a chronic condition
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    Exercise alone

    Exercise Only Group: All procedures in the exercise only treatment will be identical to the exercise and milk/yogurt groups, except for the dietary component. Participants in the exercise only group will be instructed to maintain their habitual low dairy diets. Nutritional guidance will still be provided to help manage increases in total daily energy expenditure from training.

    Behavioral: Exercise training

  • Experimental
    Exercise + Milk

    Exercise and Milk Group: Participants assigned to the exercise and milk group will begin a 12-week structured exercise program. In addition to exercise training, participants in the exercise and milk group will consume 2 servings of 1% MF milk (1 serving = 250 mL) on non-training days and 3 servings on training days, integrated into their habitual diets. Nutritional guidance from a registered dietitian will be provided to help manage increases in total daily energy expenditure from training, and increased energy intake from milk consumption.

    Dietary Supplement: Milk · Behavioral: Exercise training

  • Experimental
    Exercise + Greek Yogurt

    Exercise and Greek Yogurt Group: All procedures in the exercise and GY treatment group will be identical to the exercise and milk group, except for what dairy product is consumed. Exercise and GY participants will consume 3 servings of plain or flavoured GY (1 serving = 175 g) on training days, and 2 servings of GY on non-training days.

    Dietary Supplement: Greek Yogurt · Behavioral: Exercise training

Interventions

  • Dietary supplementMilk

    2 servings of 1% MF milk (1 serving = 250 mL) on non-training days and 3 servings on training days, integrated into habitual diet.

  • Dietary supplementGreek Yogurt

    2 servings of plain or flavoured GY (1 serving = 175 g) on non-training days, and 3 servings of GY on training days, integrated into your habitual diet.

  • BehavioralExercise training

    12-week structured exercise training program. Exercise sessions will take place three times per week and will last approximately 60 minutes per session. Sessions will be conducted at York University in the Exercise Research Lab. Each session will be facilitated by a certified personal trainer and/or kinesiology student

06

What researchers measure

Primary outcomes

  1. Inflammatory Cytokines assessed from blood samples via Elisa

    e.g., Interleukin-6 (IL-6)

    Time frame: week 0 and week 12

  2. Body Composition determined via Bodpod

    e.g., Lean mass

    Time frame: week 0 and week 12

  3. Bone turnover assessed from blood samples via Elisa

    e.g., Procollagen type 1 N-propeptide (P1NP)

    Time frame: week 0 and week 12

Secondary outcomes

  1. Immune system function (ex vivo cellular leukocyte analyses) via flow cytometry

    e.g., monocyte cell counts

    Time frame: week 0 and week 12

  2. Body Composition determined via Bodpod

    Body fat mass

    Time frame: week 0 and week 12

  3. Body Composition determined via Bodpod

    % body fat

    Time frame: week 0 and week 12

  4. Muscle thickness determined by ultrasound

    Thickness and Cross-sectional area

    Time frame: week 0 and week 12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — If data are shared with other individuals not listed on the original approved ethics or who are not part of the initial research team, it would be for reasons relating to secondary use of data for research purposes. Only deidentified/anonymized data will be shared for such purposes. No participant identifying information will be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2026; primary completion for Dec 2027, 19 months later.

Of 1,300 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 19 months is close to that.

Counting every sponsor, half of 1,411 studies reached it within 17 months; a quarter within 8 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2026
First posted
Apr 7, 2026
StartEst.
May 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Apr 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07513987
Lead sponsor
York University
Responsible party
Andrea Josse (Associate Professor, York University) — Principal investigator
First posted
Apr 7, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 7, 2026

Study contacts

Andrea Josse, PhD
Contact
ajosse@yorku.ca
416-736-2100 ext. 33990
Ali Abdul-Sater, PhD
Contact
aasater@yorku.ca
Nicholas Cheng, MSc
study director · York University
Andrea Josse, PhD
principal investigator · York University
Ali Abdul-Sater, PhD
principal investigator · York University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: cow's milk

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