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Bone and Inflammatory Outcomes - Nutrition and Exercise Trials (BIONEX)

Primary Purpose

Healthy, Bone, Inflammation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-Intensity Exercise
Carbohydrate (Maltodextrin powder mixed with water)
Skim Milk
Greek yogurt
Water
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Bone health, Females, Dairy, Exercise, Inflammation

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Between the ages of 18-30 years Normal BMI (18.5-24.9) kg/m^2 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 naturally cycling with a regular menstrual cycle) Exclusion Criteria: Regular smoker (cigarettes, e-cigarettes (e.g., vapes) or cannabis) Any chronic condition, inflammatory, or auto-immune condition

Sites / Locations

  • York University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Exercise and Greek Yogurt (GY)

Exercise and Milk (Milk)

Exercise and Carbohydrate (CHO)

Exercise and Water (W)

Arm Description

Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~200g Greek yogurt (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~200g of Greek yogurt. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.

Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml plain skim milk (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of skim milk. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.

Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~50g of maltodextrin mixed with water (~500ml). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of the maltodextrin drink. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.

Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml water. An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml water. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.

Outcomes

Primary Outcome Measures

Acute Bone Turnover/Cell Activity
OPG measured in serum/plasma
Acute Bone Turnover/Cell Activity
RANKL measured in serum/plasma
Acute Bone Turnover/Cell Activity
OC measured in serum/plasma
Acute Bone Turnover/Cell Activity
SOST measured in serum/plasma
Acute Bone Turnover/Cell Activity
CTX measured in serum/plasma
Acute Bone Turnover/Cell Activity
OPG measured in serum/plasma
Acute Bone Turnover/Cell Activity
RANKL measured in serum/plasma
Acute Bone Turnover/Cell Activity
OC measured in serum/plasma
Acute Bone Turnover/Cell Activity
SOST measured in serum/plasma
Acute Bone Turnover/Cell Activity
CTX measured in serum/plasma
Acute Bone Turnover/Cell Activity
OPG measured in serum/plasma
Acute Bone Turnover/Cell Activity
RANKL measured in serum/plasma
Acute Bone Turnover/Cell Activity
OC measured in serum/plasma
Acute Bone Turnover/Cell Activity
SOST measured in serum/plasma
Acute Bone Turnover/Cell Activity
CTX measured in serum/plasma
Acute Bone Turnover/Cell Activity
OPG measured in serum/plasma
Acute Bone Turnover/Cell Activity
RANKL measured in serum/plasma
Acute Bone Turnover/Cell Activity
OC measured in serum/plasma
Acute Bone Turnover/Cell Activity
SOST measured in serum/plasma
Acute Bone Turnover/Cell Activity
CTX measured in serum/plasma
Acute Bone Turnover/Cell Activity
OPG measured in serum/plasma
Acute Bone Turnover/Cell Activity
RANKL measured in serum/plasma
Acute Bone Turnover/Cell Activity
OC measured in serum/plasma
Acute Bone Turnover/Cell Activity
SOST measured in serum/plasma
Acute Bone Turnover/Cell Activity
CTX measured in serum/plasma
Systemic Inflammation - Serum/Plasma Cytokines
TNF-alpha measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-6 measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-1B measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-10 measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
TNF-alpha measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-6 measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-1B measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-10 measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
TNF-alpha measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-6 measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-1B measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-10 measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
TNF-alpha measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-6 measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-1B measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-10 measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
TNF-alpha measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-6 measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-1B measured in serum/plasma.
Systemic Inflammation - Serum/Plasma Cytokines
IL-10 measured in serum/plasma.
Systemic inflammation - Immune Cells
Leukocytes measured via flow cytometry
Systemic inflammation - Immune Cells
Leukocytes measured via flow cytometry
Systemic inflammation - Immune Cells
Leukocytes measured via flow cytometry
Systemic inflammation - Immune Cells
Leukocytes measured via flow cytometry

Secondary Outcome Measures

Muscle soreness
Muscle soreness rated on a 0-5 scale.
Muscle soreness
Muscle soreness rated on a 0-5 scale.
Muscle soreness
Muscle soreness rated on a 0-5 scale.
Muscle soreness
Muscle soreness rated on a 0-5 scale.
Performance - Jump Height
Vertical jump height measured using a counter movement jump technique.
Performance - Jump Height
Vertical jump height measured using a counter movement jump technique.
Performance - Jump Height
Vertical jump height measured using a counter movement jump technique.
Performance - Jump Height
Vertical jump height measured using a counter movement jump technique.

Full Information

First Posted
August 25, 2023
Last Updated
September 13, 2023
Sponsor
York University
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1. Study Identification

Unique Protocol Identification Number
NCT06041087
Brief Title
Bone and Inflammatory Outcomes - Nutrition and Exercise Trials
Acronym
BIONEX
Official Title
Dairy Supplementation and the Post-Exercise Bone and Inflammatory Response
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigates whether dairy products will positively impact loading exercise-induced bone turnover and bone cell activity and/or the post-exercise inflammatory response in healthy young adults compared to a carbohydrate drink and/or water.
Detailed Description
Introduction: Two million individuals at a cost of around 4.6 billion dollars a year in Canada suffer from osteoporosis. It is important to investigate strategies that can reduce bone loss and/or increase bone mass. Similarly, inflammation is associated with many different disease states, and investigating strategies to reduce systemic inflammation is prudent. Nutrition and exercise may be inexpensive and accessible strategies to improve bone health and inflammation and should be explored in different contexts and implemented. Our proposed research combines both nutrition and exercise along with the assessment of bone turnover and inflammatory markers in healthy young adults. Design: Randomized controlled crossover trial Participants: Healthy, university aged males and females. Methods: During the study participants will complete 4 different acute exercise and nutritional supplement trials, in random order. The four trials are: 1) exercise+carbohydrate (CHO), 2) exercise+milk (Milk), 3) exercise+Greek yogurt (GY), and 4) exercise+water (W). The whole study will take a maximum of 16 weeks and each supplement trial will be separated by 2-4 weeks. Outcomes: several markers of bone turnover and bone cell activity as well as markers of inflammation will be measured in the blood, before exercise and at different times post-exercise and post supplement consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Bone, Inflammation
Keywords
Bone health, Females, Dairy, Exercise, Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Greek Yogurt (GY)
Arm Type
Experimental
Arm Description
Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~200g Greek yogurt (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~200g of Greek yogurt. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
Arm Title
Exercise and Milk (Milk)
Arm Type
Experimental
Arm Description
Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml plain skim milk (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of skim milk. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
Arm Title
Exercise and Carbohydrate (CHO)
Arm Type
Active Comparator
Arm Description
Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~50g of maltodextrin mixed with water (~500ml). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of the maltodextrin drink. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
Arm Title
Exercise and Water (W)
Arm Type
Placebo Comparator
Arm Description
Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml water. An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml water. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
Intervention Type
Behavioral
Intervention Name(s)
High-Intensity Exercise
Intervention Description
A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate (Maltodextrin powder mixed with water)
Other Intervention Name(s)
CHO
Intervention Description
50g consumed immediately after exercise and 1h after exercise.
Intervention Type
Dietary Supplement
Intervention Name(s)
Skim Milk
Other Intervention Name(s)
Milk
Intervention Description
500ml consumed immediately after exercise and 1h after exercise.
Intervention Type
Dietary Supplement
Intervention Name(s)
Greek yogurt
Other Intervention Name(s)
GY
Intervention Description
200g consumed immediately after exercise and 1h after exercise.
Intervention Type
Dietary Supplement
Intervention Name(s)
Water
Other Intervention Name(s)
W
Intervention Description
500ml consumed immediately after exercise and 1h after exercise.
Primary Outcome Measure Information:
Title
Acute Bone Turnover/Cell Activity
Description
OPG measured in serum/plasma
Time Frame
Pre-exercise
Title
Acute Bone Turnover/Cell Activity
Description
RANKL measured in serum/plasma
Time Frame
Pre-exercise
Title
Acute Bone Turnover/Cell Activity
Description
OC measured in serum/plasma
Time Frame
Pre-exercise
Title
Acute Bone Turnover/Cell Activity
Description
SOST measured in serum/plasma
Time Frame
Pre-exercise
Title
Acute Bone Turnover/Cell Activity
Description
CTX measured in serum/plasma
Time Frame
Pre-exercise
Title
Acute Bone Turnover/Cell Activity
Description
OPG measured in serum/plasma
Time Frame
5 minutes post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
RANKL measured in serum/plasma
Time Frame
5 minutes post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
OC measured in serum/plasma
Time Frame
5 minutes post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
SOST measured in serum/plasma
Time Frame
5 minutes post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
CTX measured in serum/plasma
Time Frame
5 minutes post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
OPG measured in serum/plasma
Time Frame
1 hour post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
RANKL measured in serum/plasma
Time Frame
1 hour post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
OC measured in serum/plasma
Time Frame
1 hour post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
SOST measured in serum/plasma
Time Frame
1 hour post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
CTX measured in serum/plasma
Time Frame
1 hour post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
OPG measured in serum/plasma
Time Frame
4 hours post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
RANKL measured in serum/plasma
Time Frame
4 hours post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
OC measured in serum/plasma
Time Frame
4 hours post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
SOST measured in serum/plasma
Time Frame
4 hours post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
CTX measured in serum/plasma
Time Frame
4 hours post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
OPG measured in serum/plasma
Time Frame
24 hours post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
RANKL measured in serum/plasma
Time Frame
24 hours post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
OC measured in serum/plasma
Time Frame
24 hours post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
SOST measured in serum/plasma
Time Frame
24 hours post-exercise
Title
Acute Bone Turnover/Cell Activity
Description
CTX measured in serum/plasma
Time Frame
24 hours post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
TNF-alpha measured in serum/plasma.
Time Frame
Pre-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-6 measured in serum/plasma.
Time Frame
Pre-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-1B measured in serum/plasma.
Time Frame
Pre-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-10 measured in serum/plasma.
Time Frame
Pre-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
TNF-alpha measured in serum/plasma.
Time Frame
5 minutes post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-6 measured in serum/plasma.
Time Frame
5 minutes post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-1B measured in serum/plasma.
Time Frame
5 minutes post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-10 measured in serum/plasma.
Time Frame
5 minutes post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
TNF-alpha measured in serum/plasma.
Time Frame
1 hour post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-6 measured in serum/plasma.
Time Frame
1 hour post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-1B measured in serum/plasma.
Time Frame
1 hour post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-10 measured in serum/plasma.
Time Frame
1 hour post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
TNF-alpha measured in serum/plasma.
Time Frame
4 hours post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-6 measured in serum/plasma.
Time Frame
4 hours post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-1B measured in serum/plasma.
Time Frame
4 hours post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-10 measured in serum/plasma.
Time Frame
4 hours post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
TNF-alpha measured in serum/plasma.
Time Frame
24 hours post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-6 measured in serum/plasma.
Time Frame
24 hours post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-1B measured in serum/plasma.
Time Frame
24 hours post-exercise
Title
Systemic Inflammation - Serum/Plasma Cytokines
Description
IL-10 measured in serum/plasma.
Time Frame
24 hours post-exercise
Title
Systemic inflammation - Immune Cells
Description
Leukocytes measured via flow cytometry
Time Frame
Pre-exercise
Title
Systemic inflammation - Immune Cells
Description
Leukocytes measured via flow cytometry
Time Frame
1 hour post-exercise
Title
Systemic inflammation - Immune Cells
Description
Leukocytes measured via flow cytometry
Time Frame
4 hours post-exercise
Title
Systemic inflammation - Immune Cells
Description
Leukocytes measured via flow cytometry
Time Frame
24 hours post-exercise
Secondary Outcome Measure Information:
Title
Muscle soreness
Description
Muscle soreness rated on a 0-5 scale.
Time Frame
Pre-exercise
Title
Muscle soreness
Description
Muscle soreness rated on a 0-5 scale.
Time Frame
5 minutes post-exercise
Title
Muscle soreness
Description
Muscle soreness rated on a 0-5 scale.
Time Frame
4 hours post-exercise
Title
Muscle soreness
Description
Muscle soreness rated on a 0-5 scale.
Time Frame
24 hours post-exercise
Title
Performance - Jump Height
Description
Vertical jump height measured using a counter movement jump technique.
Time Frame
Pre-exercise
Title
Performance - Jump Height
Description
Vertical jump height measured using a counter movement jump technique.
Time Frame
5 minutes post-exercise
Title
Performance - Jump Height
Description
Vertical jump height measured using a counter movement jump technique.
Time Frame
4 hours post-exercise
Title
Performance - Jump Height
Description
Vertical jump height measured using a counter movement jump technique.
Time Frame
24 hours post-exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between the ages of 18-30 years Normal BMI (18.5-24.9) kg/m^2 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 naturally cycling with a regular menstrual cycle) Exclusion Criteria: Regular smoker (cigarettes, e-cigarettes (e.g., vapes) or cannabis) Any chronic condition, inflammatory, or auto-immune condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea R Josse, PhD
Phone
1-416-736-2100
Ext
30038
Email
ajosse@yorku.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Emily C Fraschetti, MSc
Email
ecfrasch@yorku.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea R Josse, PhD
Organizational Affiliation
York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
York University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J1P3
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea R Josse, PhD
Phone
1-(416)-736-2100
Ext
30038
Email
ajosse@yorku.ca
First Name & Middle Initial & Last Name & Degree
Emily C Fraschetti, MSc
Phone
1-(416) 736-2100
Ext
33990
Email
ecfrasch@yorku.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

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