Overweight (BMI > 25)NCT07513987
IMPACT: Immune and Musculoskeletal Physiological Adaptations to Combined Exercise Training & Nutrition
A study testing Milk, Greek Yogurt and Exercise training in people with Overweight (BMI > 25) and Males and Females, run by York University at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight (BMI > 25), Males and Females
- What is being tested?
- Milk, Greek Yogurt and Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 50 years
- Overweight BMI (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)
Who cannot join
- Peri- or postmenopausal status (female)
- Dairy protein allergy or lactose intolerance
- Use of vitamin D and/or calcium supplements
- Any musculoskeletal, autoimmune, or inflammatory conditions
- Use of medication related to a chronic condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ali Abdul-Sater, PhD contact
About this study
Official title: Investigating Different Dairy Wholefoods in Combination With Exercise on Inflammation, Immune Cell Function and Musculoskeletal Health in Overweight Adults
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.
- Conditions
- Overweight (BMI > 25), Males and Females
- Being tested
- Milk, Greek Yogurt, Exercise training
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkDietary supplement
2 servings of 1% MF milk (1 serving = 250 mL) on non-training days and 3 servings on training days, integrated into habitual diet.
Greek YogurtDietary supplement
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.
Exercise trainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise alone | Placebo comparator | 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. Receives: Behavioral: Exercise training |
| Exercise + Milk | Experimental | 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. Receives: Dietary Supplement: Milk; Behavioral: Exercise training |
| Exercise + Greek Yogurt | Experimental | 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. Receives: Dietary Supplement: Greek Yogurt; Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Cytokines assessed from blood samples via Elisa
e.g., Interleukin-6 (IL-6)
Measured: week 0 and week 12
Body Composition determined via Bodpod
e.g., Lean mass
Measured: week 0 and week 12
Bone turnover assessed from blood samples via Elisa
e.g., Procollagen type 1 N-propeptide (P1NP)
Measured: week 0 and week 12
Secondary outcomes (4)
Immune system function (ex vivo cellular leukocyte analyses) via flow cytometry
e.g., monocyte cell counts
Measured: week 0 and week 12
Body Composition determined via Bodpod
Body fat mass
Measured: week 0 and week 12
Body Composition determined via Bodpod
% body fat
Measured: week 0 and week 12
Muscle thickness determined by ultrasound
Thickness and Cross-sectional area
Measured: week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight (BMI > 25)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Josse, York University
- Investigators
- Nicholas Cheng, MSc, Study director, York UniversityAndrea Josse, PhD, Principal investigator, York UniversityAli Abdul-Sater, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513987
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Different Dairy Wholefoods in Combination With Exercise on Inflammation, Immune Cell Function and Musculoskeletal Health in Overweight Adults
- ClinicalTrials.gov ID
- NCT07513987
- Conditions
- Overweight (BMI > 25), Males and Females
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- 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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise alone | Placebo comparator | Behavioral: Exercise trainingExercise 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. |
| Exercise + Milk | Experimental | Dietary Supplement: Milk, Behavioral: Exercise trainingExercise 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. |
| Exercise + Greek Yogurt | Experimental | Dietary Supplement: Greek Yogurt, Behavioral: Exercise trainingExercise 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 18 and 50 years
- Overweight BMI (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)
Key exclusion criteria (5 listed)
- Peri- or postmenopausal status (female)
- Dairy protein allergy or lactose intolerance
- Use of vitamin D and/or calcium supplements
- Any musculoskeletal, autoimmune, or inflammatory conditions
- Use of medication related to a chronic condition
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 |
|---|---|---|
| Milk2 servings of 1% MF milk (1 serving = 250 mL) on non-training days and 3 servings on training days, integrated into habitual diet. | Dietary supplement | Exercise + Milk |
| Greek Yogurt2 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. | Dietary supplement | Exercise + Greek Yogurt |
| Exercise training12-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 | Behavioural | Exercise + Greek Yogurt, Exercise + Milk, Exercise alone |
Primary outcome
Inflammatory Cytokines assessed from blood samples via Elisa
Time frame: week 0 and week 12
e.g., Interleukin-6 (IL-6)
Body Composition determined via Bodpod
Time frame: week 0 and week 12
e.g., Lean mass
Bone turnover assessed from blood samples via Elisa
Time frame: week 0 and week 12
e.g., Procollagen type 1 N-propeptide (P1NP)
4 secondary outcomes
Immune system function (ex vivo cellular leukocyte analyses) via flow cytometry
Time frame: week 0 and week 12
Body Composition determined via Bodpod
Time frame: week 0 and week 12
Body Composition determined via Bodpod
Time frame: week 0 and week 12
Muscle thickness determined by ultrasound
Time frame: week 0 and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: 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.
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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.
Ali Abdul-Sater, PhD contact
Nicholas Cheng, MSc study director
York University
Andrea Josse, PhD principal investigator
York University
Ali Abdul-Sater, PhD principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk, Greek Yogurt and Exercise training in people with Overweight (BMI > 25) and Males and Females, run by York University 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Josse, PhD (416-736-2100 ext. 33990, ajosse@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Cytokines assessed from blood samples via Elisa (time frame: week 0 and week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.