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Bone Response to Exercise and Energy Restriction in Young Adults

Primary Purpose

Bone Resorption, Bone Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Energy restriction
Sponsored by
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Resorption focused on measuring bone, biomarkers, cycling, diet, youth, females

Eligibility Criteria

20 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Caucasian males and females, aged 20 to 25 years
  • healthy (not suffering from asthma)
  • without any fracture over the last year
  • not taking any medication related to a chronic condition or bone health including food/nutritional supplements (e.g. protein, vitamin D, calcium)
  • nonsmokers
  • females on monophasic oral contraceptives.

Exclusion Criteria:

  • Injuries or chronic conditions in which exercise may pose a risk (e.g., ACL or knee/hip/lower back injuries, arthritis, osteoporosis, neuromuscular diseases)
  • any restrictive food allergies or dietary restrictions that would require alterations to the diet plan (i.e, vegan, vegetarian) and or
  • any eating disorders (e.g., bulimia, and or anorexia)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants

    Arm Description

    For a period of 6 days between the exercise trials (i.e., following visit 3), each participant will be put on a restricted energy restricted diet consisting of a 25% reduction in their habitual total daily calorie intake. To keep the diet consistent and standardized, participants will record their typical food intake during a control week using the "Eat This Much" app, which will then provide an overall portion plan and the 25% caloric restriction measure for the intervention week. Thus, the intervention diet will mirror the control diet in terms of types of food consumed, with the difference being in the amount consumed. There will be no restriction regarding water, but drinks will be restricted according to the overall calorie intake plan.

    Outcomes

    Primary Outcome Measures

    Bone turnover marker
    Osteocalcin in ng/ml
    Bone formation marker
    Bone-specific alkaline phosphatase [BAP] in ng/ml
    Bone resorption marker
    C-telopeptides of type I collagen [CTX] in ng/ml
    Bone formation osteokine
    Osteoprotegerin [OPG] in ng/ml
    Bone resorption osteokine
    Receptor activator of nuclear factor κB ligand [RANKL] in ng/ml
    Wnt signaling related osteokine
    Sclerostin in ng/ml
    Anti-inflammatory cytokine
    Interleukin 10 [IL-10] in pg/ml
    Pro-inflammatory cytokine
    Tumor necrosis factor alpha (TNF-α) in pg/ml
    Myokine
    Interleukin 6 [IL-6] in pg/ml
    Irisin
    Irisin in pg/ml
    Oxidative stress marker
    protein carbonyls (PC) in mmol/mg serum protein

    Secondary Outcome Measures

    Body mass
    Total body mass in kg
    Lean body mass
    Fat-free mass in kg
    Fat body mass
    Fat mass in kg

    Full Information

    First Posted
    April 10, 2020
    Last Updated
    June 3, 2023
    Sponsor
    Brock University
    Collaborators
    Natural Sciences and Engineering Research Council, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04345250
    Brief Title
    Bone Response to Exercise and Energy Restriction in Young Adults
    Official Title
    Bone Response to Exercise Before and After One Week of Energy Restriction in Young Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    December 24, 2024 (Anticipated)
    Study Completion Date
    December 18, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brock University
    Collaborators
    Natural Sciences and Engineering Research Council, Canada

    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
    Cycling is commonly questioned whether it provides adequate mechanical strain on bone as many elite cyclists have been found to have a low bone mass. However, it remains unclear if this is due to cycling or low energy availability. In addition, acute dietary energy restriction has been found to be accompanied by an imbalance in bone remodelling with reduced bone formation. The objective of this proposal is to examine whether short-term energy restriction leads to changes in markers of bone formation and resorption at rest and in response to cycling in young adults. Specifically, the study will examine changes in circulating bone markers in 15 males and females (ages 18-24) both at rest and following one 45-minute spinning class both before and after one week of restricted energy intake. Blood will be drawn at rest (pre-trial, fasted), and 3 times post-trial (5 min, 1h and 24h); then analysed for biochemical markers of bone formation (BAP and OPG) and resorption (CTX and RANKL) to assess the impact of energy restriction on bone at rest and in response to exercise. This innovative work has potential to make significant advances in understanding tissue growth and development in response to exercise and malnutrition.
    Detailed Description
    Introduction: The skeletal system serves a variety of purposes such as providing structural support, locomotion, protection and more. In order to sustain these functions, bone strength must be upheld. The process of replacing older, microdamaged bone with newer, healthier bone is known as bone remodelling. Bone remodelling involves the balance/coupling of bone resorption and bone formation. Mechanical loading is the magnitude of stress placed on the bone that stimulates bone remodelling, which determines bone mineral density (BMD) and promotes bone growth (Olmedillas et al. 2011). Thus, human research on the determinants of bone growth and strength, is focused on two common factors, exercise and nutrition. Although cycling, a predominantly aerobic exercise, is exceptional for cardiovascular fitness, it is commonly questioned whether it provide adequate mechanical strain on bone. To date the literature surrounding cycling and its impact on bone is contradicting and limited. Inadequate energy intake may also influence BMD via reductions in bone mineral content. Energy restriction is known to reduce insulin-like growth factor 1 (IGF-1), which plays an important role in bone formation 5. Acute dietary energy restriction has been found to be accompanied by an imbalance of bone remodelling with reduced bone formation, which is especially dangerous in aerobic sports that expend a great amount of energy, such as cycling. Many professional and master cyclists are classified as osteopenic (Medelli et al. 2000). Specifically, female cyclists have shown significant lower values of whole-body BMD, and a lower bone strength, than male cyclists (Olmedillas et al. 2011). In addition, female cyclists are known to be energy deficient (low calorie intake) with the average energy intake being 85% of the Recommended Dietary Allowance (RDA). Therefore, it is important to understand whether cycling is a poor form of exercise for bone health or whether the energy restriction, alone or in combination with cycling, is the true underlining issue. Objective: The objective of this study is to examine whether short-term energy restriction leads to changes in markers of inflammation, oxidative stress, bone turnover at rest and in response to cycling in young adults. Specifically, the study will examine changes in circulating bone markers at rest and following one bout of low impact 45-minute spinning (cycling) both before and after one week of restricted energy intake. Methods: Fifteen healthy males and females, aged 20-25 years, will be invited to participate in this study, which involves one control trial and two exercise trial visits scheduled one week apart. Females will be on monophasic oral contraceptives, During the control trial, participants will be briefed on the purpose and procedures, will fill out an exercise screening questionnaire, and will provide 4 resting blood samples. One week later, participants will perform the first exercise trial of one 45 minute spin session. Following the first trial, the participants will go on a predetermined energy deficient diet (25% of their habitual diet) for one week, at the end of which they will perform the second trial following the same cycling protocol. Between the first and last visit the participants will be receiving a Fitbit to monitor their activity (steps, heart rate, physical activity participation) and nutritional habits in a food log. To keep the diet consistent and standardized, participants will also be asked to record their habitual food intake during the control week using the "Eat This Much" app, which will provide an overall portion plan and a 25% caloric restriction measure for the intervention week. Thus, the intervention diet will mirror the control diet in terms of types of food consumed, with the difference being in the amount consumed. There will be no restriction regarding water, but drinks will be restricted according to the overall calorie intake plan.In both trials, blood will be drawn at rest (i.e., pre-trial, fasted), and 3 times post-trial (5 min, 1h and 24h). The blood will be centrifuged and the serum separated, aliquoted and then stored at -80 °C until analysis 8. The serum will be analysed for biochemical markers of bone turnover (e.g. osteocalcin, bone-specific alkaline phosphatase [BAP]; osteoprotegerin [OPG]) and bone resorption (C-telopeptides of type I collagen [CTX]; receptor activator of nuclear factor κB ligand [RANKL], sclerostin) to assess the impact of energy restriction on bone at rest and in response to exercise. Metabolic and oxidative stress markers, inflammatory cytokines, adipokines, growth factors and hormones will also be assessed to examine potential mediating effects. Impact: This innovative work has the potential to make significant advances in understanding the impact of energy restriction and cycling on bone health. The findings from this work will be translatable to understanding tissue growth and development in response exercise and malnutrition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Resorption, Bone Loss
    Keywords
    bone, biomarkers, cycling, diet, youth, females

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single group, pre to post one week intervention
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants
    Arm Type
    Experimental
    Arm Description
    For a period of 6 days between the exercise trials (i.e., following visit 3), each participant will be put on a restricted energy restricted diet consisting of a 25% reduction in their habitual total daily calorie intake. To keep the diet consistent and standardized, participants will record their typical food intake during a control week using the "Eat This Much" app, which will then provide an overall portion plan and the 25% caloric restriction measure for the intervention week. Thus, the intervention diet will mirror the control diet in terms of types of food consumed, with the difference being in the amount consumed. There will be no restriction regarding water, but drinks will be restricted according to the overall calorie intake plan.
    Intervention Type
    Other
    Intervention Name(s)
    Energy restriction
    Intervention Description
    A 25% reduction in total caloric intake, as calculated through the app. Therefore, during the control period, participants will input what they consume into the Eat This Much app, then the app will calculate the 25% reduction in calories to present participants with how much to consume of the same foods. By doing this their diet will not be altered in terms of macronutrients or micronutrients, but solely on calories.
    Primary Outcome Measure Information:
    Title
    Bone turnover marker
    Description
    Osteocalcin in ng/ml
    Time Frame
    one week
    Title
    Bone formation marker
    Description
    Bone-specific alkaline phosphatase [BAP] in ng/ml
    Time Frame
    one week
    Title
    Bone resorption marker
    Description
    C-telopeptides of type I collagen [CTX] in ng/ml
    Time Frame
    one week
    Title
    Bone formation osteokine
    Description
    Osteoprotegerin [OPG] in ng/ml
    Time Frame
    one week
    Title
    Bone resorption osteokine
    Description
    Receptor activator of nuclear factor κB ligand [RANKL] in ng/ml
    Time Frame
    one week
    Title
    Wnt signaling related osteokine
    Description
    Sclerostin in ng/ml
    Time Frame
    one week
    Title
    Anti-inflammatory cytokine
    Description
    Interleukin 10 [IL-10] in pg/ml
    Time Frame
    one week
    Title
    Pro-inflammatory cytokine
    Description
    Tumor necrosis factor alpha (TNF-α) in pg/ml
    Time Frame
    one week
    Title
    Myokine
    Description
    Interleukin 6 [IL-6] in pg/ml
    Time Frame
    one week
    Title
    Irisin
    Description
    Irisin in pg/ml
    Time Frame
    one week
    Title
    Oxidative stress marker
    Description
    protein carbonyls (PC) in mmol/mg serum protein
    Time Frame
    one week
    Secondary Outcome Measure Information:
    Title
    Body mass
    Description
    Total body mass in kg
    Time Frame
    one week
    Title
    Lean body mass
    Description
    Fat-free mass in kg
    Time Frame
    one week
    Title
    Fat body mass
    Description
    Fat mass in kg
    Time Frame
    one week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Caucasian males and females, aged 20 to 25 years healthy (not suffering from asthma) without any fracture over the last year not taking any medication related to a chronic condition or bone health including food/nutritional supplements (e.g. protein, vitamin D, calcium) nonsmokers females on monophasic oral contraceptives. Exclusion Criteria: Injuries or chronic conditions in which exercise may pose a risk (e.g., ACL or knee/hip/lower back injuries, arthritis, osteoporosis, neuromuscular diseases) any restrictive food allergies or dietary restrictions that would require alterations to the diet plan (i.e, vegan, vegetarian) and or any eating disorders (e.g., bulimia, and or anorexia)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Panagiota Klentrou, PhD
    Phone
    1-905-688-5550
    Ext
    4538
    Email
    nklentrou@brocku.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Madison Bell, BSc
    Phone
    1-705-279-3113
    Email
    mb14pf@brocku.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Panagiota Klentrou, PhD
    Organizational Affiliation
    Brock University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21980360
    Citation
    Olmedillas H, Gonzalez-Aguero A, Moreno LA, Casajus JA, Vicente-Rodriguez G. Bone related health status in adolescent cyclists. PLoS One. 2011;6(9):e24841. doi: 10.1371/journal.pone.0024841. Epub 2011 Sep 30.
    Results Reference
    background
    PubMed Identifier
    18835799
    Citation
    Medelli J, Lounana J, Menuet JJ, Shabani M, Cordero-MacIntyre Z. Is osteopenia a health risk in professional cyclists? J Clin Densitom. 2009 Jan-Mar;12(1):28-34. doi: 10.1016/j.jocd.2008.07.057. Epub 2008 Oct 1.
    Results Reference
    background

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    Bone Response to Exercise and Energy Restriction in Young Adults

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