Bone ResorptionNCT04345250
Bone Response to Exercise and Energy Restriction in Young Adults
A study testing Energy restriction in people with Bone Resorption and Bone Loss, run by Brock University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption, Bone Loss
- What is being tested?
- Energy restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Response to Exercise Before and After One Week of Energy Restriction in Young Adults
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.
Read the 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.
- Conditions
- Bone Resorption, Bone Loss
- Being tested
- Energy restriction
- Keywords
- bone, biomarkers, cycling, diet, youth, females
- Medical subject headings
- Bone Resorption, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy restrictionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone turnover marker
Osteocalcin in ng/ml
Measured: one week
Bone formation marker
Bone-specific alkaline phosphatase [BAP] in ng/ml
Measured: one week
Bone resorption marker
C-telopeptides of type I collagen [CTX] in ng/ml
Measured: one week
Bone formation osteokine
Osteoprotegerin [OPG] in ng/ml
Measured: one week
Bone resorption osteokine
Receptor activator of nuclear factor κB ligand [RANKL] in ng/ml
Measured: one week
Wnt signaling related osteokine
Sclerostin in ng/ml
Measured: one week
Anti-inflammatory cytokine
Interleukin 10 [IL-10] in pg/ml
Measured: one week
Pro-inflammatory cytokine
Tumor necrosis factor alpha (TNF-α) in pg/ml
Measured: one week
Myokine
Interleukin 6 [IL-6] in pg/ml
Measured: one week
Irisin
Irisin in pg/ml
Measured: one week
Oxidative stress marker
protein carbonyls (PC) in mmol/mg serum protein
Measured: one week
Secondary outcomes (3)
Body mass
Total body mass in kg
Measured: one week
Lean body mass
Fat-free mass in kg
Measured: one week
Fat body mass
Fat mass in kg
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start30 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Why it stopped: The study was suspended during the COVID-19 pandemic and has not resumed yet.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, pre to post one week intervention
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Panagiota Klentrou, Brock University
- Investigators
- Panagiota Klentrou, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345250
- Sponsor's protocol ID
- REB 19-247
- Status last verified
- Dec 2024
- First submitted
- 10 Apr 2020
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21980360Medelli 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.
PubMed 18835799
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Response to Exercise Before and After One Week of Energy Restriction in Young Adults
- ClinicalTrials.gov ID
- NCT04345250
- Acronym / sponsor ID
- REB 19-247
- Conditions
- Bone Resorption, Bone Loss
- Keywords
- bone, biomarkers, cycling, diet, youth, females
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study was suspended during the COVID-19 pandemic and has not resumed yet.
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, pre to post one week intervention
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: Energy restrictionFor 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. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy restrictionA 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. | Other | Participants |
Primary outcome
Bone turnover marker
Time frame: one week
Osteocalcin in ng/ml
Bone formation marker
Time frame: one week
Bone-specific alkaline phosphatase [BAP] in ng/ml
Bone resorption marker
Time frame: one week
C-telopeptides of type I collagen [CTX] in ng/ml
Bone formation osteokine
Time frame: one week
Osteoprotegerin [OPG] in ng/ml
Bone resorption osteokine
Time frame: one week
Receptor activator of nuclear factor κB ligand [RANKL] in ng/ml
Wnt signaling related osteokine
Time frame: one week
Sclerostin in ng/ml
Anti-inflammatory cytokine
Time frame: one week
Interleukin 10 [IL-10] in pg/ml
Pro-inflammatory cytokine
Time frame: one week
Tumor necrosis factor alpha (TNF-α) in pg/ml
Myokine
Time frame: one week
Interleukin 6 [IL-6] in pg/ml
Irisin
Time frame: one week
Irisin in pg/ml
Oxidative stress marker
Time frame: one week
protein carbonyls (PC) in mmol/mg serum protein
3 secondary outcomes
Body mass
Time frame: one week
Lean body mass
Time frame: one week
Fat body mass
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 21980360Olmedillas 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.
- Background: PubMed 18835799Medelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panagiota Klentrou, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy restriction in people with Bone Resorption and Bone Loss, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone turnover marker (time frame: one week). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04345250, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.