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Cycling Duration and Bone Markers in in Active Young Adults

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ClinicalTrials.gov Identifier: NCT04380155
Recruitment Status : Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : September 15, 2020
Sponsor:
Collaborator:
Natural Sciences and Engineering Research Council, Canada
Information provided by (Responsible Party):
PKlentrou, Brock University

Brief Summary:
Exercise is an important factor in bone health. Sclerostin is one of the key molecules involved in bone response to mechanical loading. In particular, sclerostin decreases bone formation directly through the inhibition of Wnt/ β-catenin signaling and increases bone resorption indirectly via upregulation of the RANK/RANKL. The Wnt pathway is an anabolic signaling pathway, which leads to the activation of osteoblasts. OPG is another osteokine secreted by osteoblasts and osteogenic stomal cells that has a protective osteogenic role in humans by inhibiting the binding of RANKL to its receptor RANK. The RANK/RANKL pathway is a catabolic signaling pathway controlling osteoclast differentiation. Only a few studies have examined the effects of one single bout of high impact exercise on serum sclerostin levels in adults, most of which are from the investigators' lab. However, not many studies have examined the acute effects of moderate intensity, low-impact exercise on osteokines of the Wnt signaling. Previous studies have only investigated the impact of high intensity cycling on sclerostin, OPG and RANKL, however, no research has been done to investigate the response of osteokines to moderate intensity continuous cycling. This study aims to investigate differences in osteokines and markers of bone turnover following three moderate intensity cycling trials of different duration (30, 60 and 120 min) in an energy replete state. The question we aim to answer is whether there is a threshold of time where continued stimulus from moderate strain on the bone fails to elicit an additional metabolic response in bone or even becomes osteocatabolic, when athletes are in an energy replete state. Additional biochemical responses to the exercise will also be examined including inflammatory markers, glucose, anabolic/hormonal markers and oxidative stress.

Condition or disease Intervention/treatment Phase
Bone Loss Energy Supply; Deficiency Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group, cross-over, random order
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Cycling Duration on Markers of Bone Metabolism in Active Young Men
Estimated Study Start Date : September 23, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Participants
All participants will perform three moderate intensity cycling trials of different duration (30, 60 and 120 min) in an energy replete state.
Other: Exercise
Moderate intensity cycling trials of different duration (30, 60 and 120 min)




Primary Outcome Measures :
  1. C-terminal crosslinking telopeptides of type I collagen (CTX) [ Time Frame: 1 week ]
    Bone resorption marker (ng/ml)

  2. Procollagen I intact N-terminal (PINP) [ Time Frame: 1 week ]
    Bone formation marker (ng/ml)

  3. Sclerostin (pg/ml) [ Time Frame: 1 week ]
    Wnt related osteokine

  4. Osteoprotegerin (OPG) [ Time Frame: 1 week ]
    osteokine (pg/ml)

  5. Receptor activator of nuclear factor kappa-β ligand (RANKL) [ Time Frame: 1 week ]
    osteokine (pg/ml)


Secondary Outcome Measures :
  1. Tumor necrosis factor alpha (TNF-a) [ Time Frame: 1 week ]
    Pro-inflammatory cytokine (pg/ml)

  2. Interleukin 10 (IL-10) [ Time Frame: 1 week ]
    Anti-inflammatory cytokine (pg/ml)

  3. Interleukin 6 (IL-6) [ Time Frame: 1 week ]
    Myokine (pg/ml)

  4. thiobarbituric acid reactive substances (TBARS) [ Time Frame: 1 week ]
    oxidative stress marker

  5. Glucose (ng/ml) [ Time Frame: 1 week ]
    metabolic marker

  6. Insulin growth factor one (IGF-1) [ Time Frame: 1 week ]
    metabolic marker (ng/ml)



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian males,
  • aged 20 to 30 years,
  • healthy (not suffering from asthma),
  • of normal weight (BMI: 18.5 - 25 kg/m2),
  • recreationally active (i.e., regularly exercise 3-6 times per week, including 3 times of aerobic exercise over 45 min per session).

Exclusion Criteria:

  • with no 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),
  • non-smokers,
  • with no injuries or chronic conditions in which exercise may pose a risk (e.g., ACL or knee/hip/lower back injuries, arthritis, osteoporosis, neuromuscular diseases),
  • currently not on a low carbohydrate or ketogenic diet.

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): NCT04380155


Contacts
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Contact: Panagiota Klentrou, PhD 9056885550 ext 4538 nklentrou@gmail.com
Contact: Anne Guzman, BSc 9056885550 ext 5826 ag18xk@brocku.ca

Locations
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Canada, Ontario
Brock University
Saint Catharines, Ontario, Canada, L2S 3A1
Sponsors and Collaborators
Brock University
Natural Sciences and Engineering Research Council, Canada
Investigators
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Principal Investigator: Panagiota Klentrou Brock University
Publications:

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Responsible Party: PKlentrou, Professor, Brock University
ClinicalTrials.gov Identifier: NCT04380155    
Other Study ID Numbers: REB 19-266
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 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 PKlentrou, Brock University:
Bone Turnover
biomarkers
cycling
energy availability
sclerostin
OPG/RANKL
bone formation
bone resorption