- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513987
IMPACT: Immune and Musculoskeletal Physiological Adaptations to Combined Exercise Training & Nutrition
Investigating Different Dairy Wholefoods in Combination With Exercise on Inflammation, Immune Cell Function and Musculoskeletal Health in Overweight Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 With respect to exercise, new and (currently) unpublished work from our group has demonstrated some differences in the acute inflammatory response to a single exercise bout following milk or GY consumption.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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrea Josse, PhD
- Phone Number: 33990 416-736-2100
- Email: ajosse@yorku.ca
Study Contact Backup
- Name: Ali Abdul-Sater, PhD
- Email: aasater@yorku.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M3J 1P3
- York University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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
|
|
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.
|
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
2 servings of 1% MF milk (1 serving = 250 mL) on non-training days and 3 servings on training days, integrated into habitual diet.
|
|
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.
|
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammatory Cytokines assessed from blood samples via Elisa
Time Frame: week 0 and week 12
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e.g., Interleukin-6 (IL-6)
|
week 0 and week 12
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Body Composition determined via Bodpod
Time Frame: week 0 and week 12
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e.g., Lean mass
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week 0 and week 12
|
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Bone turnover assessed from blood samples via Elisa
Time Frame: week 0 and week 12
|
e.g., Procollagen type 1 N-propeptide (P1NP)
|
week 0 and week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immune system function (ex vivo cellular leukocyte analyses) via flow cytometry
Time Frame: week 0 and week 12
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e.g., monocyte cell counts
|
week 0 and week 12
|
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Body Composition determined via Bodpod
Time Frame: week 0 and week 12
|
Body fat mass
|
week 0 and week 12
|
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Body Composition determined via Bodpod
Time Frame: week 0 and week 12
|
% body fat
|
week 0 and week 12
|
|
Muscle thickness determined by ultrasound
Time Frame: week 0 and week 12
|
Thickness and Cross-sectional area
|
week 0 and week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nicholas Cheng, MSc, York University
- Principal Investigator: Andrea Josse, PhD, York University
- Principal Investigator: Ali Abdul-Sater, PhD, York University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Food
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Beverages
- Dairy Products
- Exercise
- Milk
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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