Cycling Duration and Bone Markers in in Active Young Adults

NCT04380155 | Withdrawn

• 1 other identifier: REB 19-266
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss; Energy Supply; Deficiency

Keywords

Bone Turnover; biomarkers; cycling; energy availability; sclerostin; OPG/RANKL; bone formation; bone resorption

Outcome Measures

Primary Outcomes (5)

• C-terminal crosslinking telopeptides of type I collagen (CTX)

  Bone resorption marker (ng/ml)

  1 week

• Procollagen I intact N-terminal (PINP)

  Bone formation marker (ng/ml)

  1 week

• Sclerostin (pg/ml)

  Wnt related osteokine

  1 week

• Osteoprotegerin (OPG)

  osteokine (pg/ml)

  1 week

• Receptor activator of nuclear factor kappa-β ligand (RANKL)

  osteokine (pg/ml)

  1 week

Secondary Outcomes (6)

• Tumor necrosis factor alpha (TNF-a)

  1 week

• Interleukin 10 (IL-10)

  1 week

• Interleukin 6 (IL-6)

  1 week

• thiobarbituric acid reactive substances (TBARS)

  1 week

• Glucose (ng/ml)

  1 week

Study Arms (1)

Participants

EXPERIMENTAL

All participants will perform three moderate intensity cycling trials of different duration (30, 60 and 120 min) in an energy replete state.

Other: Exercise

Interventions

Exercise OTHER

Moderate intensity cycling trials of different duration (30, 60 and 120 min)

Participants

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brock University: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

Brock University

Saint Catharines, Ontario, L2S 3A1, Canada

Location

Related Publications (8)

• Mezil YA, Allison D, Kish K, Ditor D, Ward WE, Tsiani E, Klentrou P. Response of Bone Turnover Markers and Cytokines to High-Intensity Low-Impact Exercise. Med Sci Sports Exerc. 2015 Jul;47(7):1495-502. doi: 10.1249/MSS.0000000000000555.

  PMID: 25373482 BACKGROUND

• Barry DW, Kohrt WM. Acute effects of 2 hours of moderate-intensity cycling on serum parathyroid hormone and calcium. Calcif Tissue Int. 2007 Jun;80(6):359-65. doi: 10.1007/s00223-007-9028-y. Epub 2007 Jun 5.

  PMID: 17549534 BACKGROUND

• Sherk VD, Barry DW, Villalon KL, Hansen KC, Wolfe P, Kohrt WM. Bone loss over 1 year of training and competition in female cyclists. Clin J Sport Med. 2014 Jul;24(4):331-6. doi: 10.1097/JSM.0000000000000050.

  PMID: 24326929 BACKGROUND

• Rector RS, Rogers R, Ruebel M, Hinton PS. Participation in road cycling vs running is associated with lower bone mineral density in men. Metabolism. 2008 Feb;57(2):226-32. doi: 10.1016/j.metabol.2007.09.005.

  PMID: 18191053 BACKGROUND

• 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.

  PMID: 21980360 BACKGROUND

• Hinton PS, Rolleston A, Rehrer NJ, Hellemans IJ, Miller BF. Bone formation is increased to a greater extent than bone resorption during a cycling stage race. Appl Physiol Nutr Metab. 2010 Jun;35(3):344-9. doi: 10.1139/H10-025.

  PMID: 20555379 BACKGROUND

• Heikura IA, Burke LM, Hawley JA, Ross ML, Garvican-Lewis L, Sharma AP, McKay AKA, Leckey JJ, Welvaert M, McCall L, Ackerman KE. A Short-Term Ketogenic Diet Impairs Markers of Bone Health in Response to Exercise. Front Endocrinol (Lausanne). 2020 Jan 21;10:880. doi: 10.3389/fendo.2019.00880. eCollection 2019.

  PMID: 32038477 BACKGROUND

• Robinson TL, Snow-Harter C, Taaffe DR, Gillis D, Shaw J, Marcus R. Gymnasts exhibit higher bone mass than runners despite similar prevalence of amenorrhea and oligomenorrhea. J Bone Miner Res. 1995 Jan;10(1):26-35. doi: 10.1002/jbmr.5650100107.

  PMID: 7747628 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Sclerosteosis; Bone Resorption

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Panagiota Klentrou

  Brock University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single group, cross-over, random order

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: September 20, 2023
• Primary Completion: October 29, 2023
• Study Completion: October 29, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)