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The Combined Effect of Dairy and/or Creatine and Exercise on Bone and Inflammation (Cre-Ex-Inf)

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ClinicalTrials.gov Identifier: NCT03615989
Recruitment Status : Suspended (COVID-19)
First Posted : August 6, 2018
Last Update Posted : December 24, 2020
Sponsor:
Collaborator:
Brock University
Information provided by (Responsible Party):
Andrea Josse, York University

Brief Summary:
This study analyzes whether dairy with and without creatine supplementation positively impacts loading exercise-induced bone cell activity and inflammation in healthy young females.

Condition or disease Intervention/treatment Phase
Healthy Females Bone Inflammation Behavioral: Resistance and Plyometric Exercise Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water) Dietary Supplement: Skim Milk Dietary Supplement: Creatine powder mixed with Skim Milk - OPTIONAL Not Applicable

Detailed Description:

Introduction: Two million individuals at a cost of around 2.3 billion dollars a year in Canada suffer from osteoporosis. Research that emphasizes the treatment of this disease is important, but so is research that focuses on prevention; reducing bone loss and/or increasing bone mass when young. In addition, inflammation is an issue as it strongly relates to chronic disease. Countermeasures to improve bone health and inflammation, such as nutrition and exercise, should be explored and implemented. The proposed research combines both nutrition and exercise along with the assessment of bone turnover markers and inflammation in healthy young females, and aims to determine whether dairy with and without creatine versus a carbohydrate-based beverage positively impacts acute bone turnover and the inflammatory response following a bout of resistance and plyometric exercise.

Design: Randomized controlled crossover trial.

Participants: 10-15 healthy university aged females.

Methods: Participants will be asked to complete up to 3 different acute exercise and nutritional supplement trials. Each trial will be assigned in random order. The three trials are: 1) exercise+carbohydrate (CHO), 2) exercise+milk (Milk), and 3) exercise+milk+creatine (Cre). The whole study will take a maximum of 8-12 weeks to complete as each supplement trial will be separated by 2-4 weeks. Each treatment is outlined below.

Anticipated Results: The investigators anticipate that dairy and exercise will have a greater positive impact on acute bone cell activity and inflammation in healthy young females more than exercise and CHO. Creatine+milk may impact bone more so than milk alone. Inflammation may not be impacted by creatine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized acute Crossover Trial
Masking: Single (Outcomes Assessor)
Masking Description: Those completing the analyses will be masked to the treatments.
Primary Purpose: Prevention
Official Title: Does Milk and/or Creatine Augment the Acute Effect of Exercise on Bone Turnover and Inflammation
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Exercise and Carbohydrate (CHO)
Participants will have a fasted, baseline blood sample (10ml) taken upon arrival to the lab. They will then complete a supervised resistance and plyometric exercise bout. Immediately following exercise, 51g of carbohydrate (maltodextrin) + water will be consumed. Two more blood samples will follow the exercise bout at 5 minutes post (10ml) and 1 hour post (10ml). An additional 51g of carbohydrate will be consumed with water 1 hour post exercise. Two more fasting blood samples (10ml) will be taken 24 and 48 hours later.
Behavioral: Resistance and Plyometric Exercise
A single resistance and plyometric exercise bout per trial.

Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water)
51 grams immediately after exercise bout. 51 grams 1 hour after exercise bout.
Other Name: CHO

Experimental: Exercise and Milk (Milk)
Participants will have a fasted, baseline blood sample (10ml) taken upon arrival to the lab. They will then complete a supervised resistance and plyometric exercise bout. Immediately following exercise, 555 ml of skim milk will be consumed. Two more blood samples will follow the exercise bout at 5 minutes post (10ml) and 1 hour post (10ml). An additional 555 ml of skim milk will be consumed 1 hour post exercise. Two more fasting blood samples (10ml) will be taken 24 and 48 hours later.
Behavioral: Resistance and Plyometric Exercise
A single resistance and plyometric exercise bout per trial.

Dietary Supplement: Skim Milk
555 ml immediately after exercise bout. 555 ml 1 hour after exercise bout.
Other Name: Milk

Experimental: Exercise, Milk and Creatine (Cre) - OPTIONAL
Participants will complete a 6-day creatine loading phase (5 grams x 4 times/day) before they come in for the exercise bout. Participants will have a fasted, baseline blood sample (10ml) taken upon arrival to the lab. Before the exercise bout, 5 grams of creatine will be taken. They will then complete a supervised resistance and plyometric exercise bout. Immediately following exercise, 555 ml of skim milk + 5g of creatine will be consumed. Two more blood samples will follow the exercise bout at 5 minutes post (10ml) and 1 hour post (10ml). An additional 555ml of skim milk will be consumed 1 hour post exercise without creatine. 5g of creatine will then be consumed with the participant's last meal of the day. Two more fasting blood samples (10ml) will be taken 24 and 48 hours later. On the day after exercise, participants will consume a 5g maintenance dose of creatine with their last meal of the day. This treatment arm is optional and may not be included in the inflammation analysis.
Behavioral: Resistance and Plyometric Exercise
A single resistance and plyometric exercise bout per trial.

Dietary Supplement: Skim Milk
555 ml immediately after exercise bout. 555 ml 1 hour after exercise bout.
Other Name: Milk

Dietary Supplement: Creatine powder mixed with Skim Milk - OPTIONAL
Creatine Loading Phase: 5 grams x 4 times per day for 6 days. 5 grams immediately after exercise bout. 5 grams 1 hour after exercise bout. 5 grams consumed with last meal on day of exercise bout and the day following.
Other Name: Cre




Primary Outcome Measures :
  1. Acute Bone Cell Activity [ Time Frame: Baseline ]
    Bone markers measured in serum/plasma.

  2. Acute Bone Cell Activity [ Time Frame: 5 minutes post exercise ]
    Bone markers measured in serum/plasma.

  3. Acute Bone Cell Activity [ Time Frame: 1 hour post exercise ]
    Bone markers measured in serum/plasma.

  4. Acute Bone Cell Activity [ Time Frame: 24 hours post exercise ]
    Bone markers measured in serum/plasma.

  5. Acute Bone Cell Activity [ Time Frame: 48 hours post exercise ]
    Bone markers measured in serum/plasma.


Other Outcome Measures:
  1. Inflammation [ Time Frame: Baseline ]
    Interleukin 6 measured in serum/plasma.

  2. Inflammation [ Time Frame: 5 minutes post exercise ]
    Interleukin 6 measured in serum/plasma.

  3. Inflammation [ Time Frame: 1 hour post exercise ]
    Interleukin 6 measured in serum/plasma.

  4. Inflammation [ Time Frame: 24 hour post exercise ]
    Interleukin 6 measured in serum/plasma.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female between the ages of 18 and 30 years
  • Normal BMI (18.5-24.9) kg/m2
  • Low to moderately physically active (0-2 times/week)
  • No allergy to dairy protein or lactose intolerance
  • On no medication related to a chronic condition
  • On birth control (or not but with regular mensural cycle)
  • Never before supplemented with creatine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615989


Locations
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Canada, Ontario
York University
Toronto, Ontario, Canada, M3J 1P3
Sponsors and Collaborators
York University
Brock University
Investigators
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Principal Investigator: Andrea R Josse, PhD York University
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Responsible Party: Andrea Josse, Assistant Professor, York University
ClinicalTrials.gov Identifier: NCT03615989    
Other Study ID Numbers: 2019-045
REB 17-402 ( Other Identifier: Brock University )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrea Josse, York University:
Bone Health
Females
Creatine
Dairy
Exercise
Inflammation
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes