Bone Response to Exercise and Energy Restriction in Young Adults

NCT04345250 | Suspended

• 1 other identifier: REB 19-247
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Resorption; Bone Loss

Keywords

bone; biomarkers; cycling; diet; youth; females

Outcome Measures

Primary Outcomes (11)

• Bone turnover marker

  Osteocalcin in ng/ml

  one week

• Bone formation marker

  Bone-specific alkaline phosphatase \[BAP\] in ng/ml

  one week

• Bone resorption marker

  C-telopeptides of type I collagen \[CTX\] in ng/ml

  one week

• Bone formation osteokine

  Osteoprotegerin \[OPG\] in ng/ml

  one week

• Bone resorption osteokine

  Receptor activator of nuclear factor κB ligand \[RANKL\] in ng/ml

  one week

• Wnt signaling related osteokine

  Sclerostin in ng/ml

  one week

• Anti-inflammatory cytokine

  Interleukin 10 \[IL-10\] in pg/ml

  one week

• Pro-inflammatory cytokine

  Tumor necrosis factor alpha (TNF-α) in pg/ml

  one week

• Myokine

  Interleukin 6 \[IL-6\] in pg/ml

  one week

• Irisin

  Irisin in pg/ml

  one week

• Oxidative stress marker

  protein carbonyls (PC) in mmol/mg serum protein

  one week

Secondary Outcomes (3)

• Body mass

  one week

• Lean body mass

  one week

• Fat body mass

  one week

Study Arms (1)

Participants

EXPERIMENTAL

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.

Other: Energy restriction

Interventions

Energy restriction OTHER

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.

Participants

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S 3A1, Canada

Location

Related Publications (2)

• 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

• 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.

  PMID: 18835799 BACKGROUND

MeSH Terms

Conditions

Bone Resorption; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

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

Study Officials

• Panagiota Klentrou, PhD

  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, pre to post one week intervention

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: September 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)