Osteopenia or OsteoporosisNCT06550466
The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers
A study testing Breakfast only, FAST and FED in people with Osteopenia or Osteoporosis, run by Sheffield Hallam University.
Trial summary
Osteoporosis is a major contributor to loss of independence due to bone fractures and resulting hospital treatments lead to significant morbidity. While pharmacological treatments can reduce consequences of osteoporosis, there is a pressing need for non-pharmacological interventions to improve bone health across the… Read more about this study
- Who is it for?
- Ages 24 to 32 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia or Osteoporosis
- What is being tested?
- Breakfast only, FAST and FED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Jun 2025
- 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 24 to 32 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male (females excluded to remove the interplay between menstrual cycle and bone turnover)
- Caucasian ethnicity
- Aged 28 ± 4 years
- Are physically active (meet the UK guidelines for physical activity of at least 150 minutes moderate intensity activity and/or at least 75 minutes of vigorous intensity activity per week)
- Otherwise, healthy, able and willing to participate and provide written informed consent
Who cannot join
- Current smokers
- Excessive alcohol consumption (max 15 alcohol units/week)
- Any musculoskeletal injury/disabilities
- Any conditions known to affect bone metabolism (e.g. uncontrolled hyper-/hypothyroidism, hyperparathyroidism, hypo-/hypercalcaemia) or malabsorption syndromes (e.g. Crohn's disease, coeliac disease or inflammatory bowel disease).
- Taking any medication known to affect bone metabolism (such as glucocorticoids or bisphosphonates)
- Positive Covid-19 test within the last 8 weeks
Show all 11Show fewer
- Suffered a fracture in the previous 12 months
- Sedentary status (see physical activity inclusion criteria above)
- Have been told by medical professionals that they should not take part in moderate to high intensity exercise
- Should not be a professional athlete or take part in significant competitive recreational activity (takes no more than 4 structured exercise sessions per week on average)
- History of diagnosed eating disorders
Trial locations and contacts
No sites are listed yet.
Jasmine Samvelyan, PhD contact
About this study
Official title: The Influence of Pre-exercise Feeding on Acute Bone Turnover Biomarkers in Response to Physical Activity in Healthy Participants
Osteoporosis is a major contributor to loss of independence due to bone fractures and resulting hospital treatments lead to significant morbidity. While pharmacological treatments can reduce consequences of osteoporosis, there is a pressing need for non-pharmacological interventions to improve bone health across the life-course and to reduce likelihood of age-related bone disease.
This study will allow us to determine whether synergistic potentiating effects on bone metabolism are observed in humans in relation to the timing of food ingestion and what recommendations can be made to people with respect to food ingestion and exercise to obtain the maximal bone benefits from aerobic exercise. Furthermore, if we can identify interventions that potentiate bone's response to aerobic exercise in younger adults, then such interventions may have the ability to maximise bone mass in younger adults so that with ageing, the additional bone mineral density and improved bone microarchitecture would extend the time before osteoporotic "fracture thresholds" are reached. Therefore, understanding the bone metabolic response to exercise following fasting and feeding in younger adults is important.
- Conditions
- Osteopenia or Osteoporosis
- Being tested
- Breakfast only, FAST, FED
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast onlyOther
Participants will attend a breakfast-only arm without the exercise protocol.
FASTOther
Participants will be exercised for 90 minutes following a 12-hour overnight fast
FEDOther
Participants will be exercised 90 minutes after a breakfast
| Study group | Role | What they receive |
|---|---|---|
| Breakfast only | Experimental | Breakfast only without the exercise protocol Receives: Other: Breakfast only |
| FAST | Experimental | Participants will be exercised 90 minutes following a 12-hour overnight fast Receives: Other: FAST |
| FED | Experimental | Participants will be exercised 90 minutes after a meal Receives: Other: FED |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-terminal telopeptide of type-1 collagen (CTX-1)
The primary endpoint of this study is the change of the bone resorption biomarker C-terminal telopeptide of type-1 collagen (CTX-1) expression
Measured: Between pre-exercise and 2 hours following the exercise timepoints
Secondary outcomes (4)
Procollagen type 1 N-terminal propeptide (P1NP)
The change of the bone formation biomarker procollagen type 1 N-terminal propeptide (P1NP) expression
Measured: Between pre-exercise and 2 hours following the exercise timepoints
Cortisol
Markerof physiological and psychological stress is assessed and because of its promotion of bone resorption
Measured: Between pre-exercise and 2 hours following the exercise timepoints
Insulin
The change of concentration in fasted and fed states is assessed
Measured: Between pre-exercise and 2 hours following the exercise timepoints
Glucose
The change of concentration in fasted and fed states is assessed
Measured: Between pre-exercise and 2 hours following the exercise timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia or OsteoporosisStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- In this three-arm randomised crossover study, sixteen young adult men (age: 28 ± 4) will be recruited in good physical condition. Participants will be exercised following a 12-hour overnight fast (FAST) and exercised 90 minutes after a meal (FED) to test the temporal sensitivity of the loaded bone to absorbed nutrients. Participants will also attend a breakfast-only arm (without the exercise protocol). Participants will undergo a baseline assessment for health history (PAR-Q). The blood samples will be collected (10ml) and osteogenic response to exercise will be determined by measuring markers of bone formation; P1NP and resorption; CTX-1 and cortisol; marker of physiological and psychological stress. Insulin and glucose measurements will allow to assess the change of concentrations in fasted and fed states.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University, University of Sheffield, Manchester Metropolitan University, Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550466
- Sponsor's protocol ID
- ER52048815
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pre-exercise Feeding on Acute Bone Turnover Biomarkers in Response to Physical Activity in Healthy Participants
- ClinicalTrials.gov ID
- NCT06550466
- Acronym / sponsor ID
- ER52048815
- Conditions
- Osteopenia or Osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Anglia Ruskin University, University of Sheffield, Manchester Metropolitan University, Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Aug 2024 (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.
Osteoporosis is a major contributor to loss of independence due to bone fractures and resulting hospital treatments lead to significant morbidity. While pharmacological treatments can reduce consequences of osteoporosis, there is a pressing need for non-pharmacological interventions to improve bone health across the life-course and to reduce likelihood of age-related bone disease.
This study will allow us to determine whether synergistic potentiating effects on bone metabolism are observed in humans in relation to the timing of food ingestion and what recommendations can be made to people with respect to food ingestion and exercise to obtain the maximal bone benefits from aerobic exercise. Furthermore, if we can identify interventions that potentiate bone's response to aerobic exercise in younger adults, then such interventions may have the ability to maximise bone mass in younger adults so that with ageing, the additional bone mineral density and improved bone microarchitecture would extend the time before osteoporotic "fracture thresholds" are reached. Therefore, understanding the bone metabolic response to exercise following fasting and feeding in younger adults is important.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In this three-arm randomised crossover study, sixteen young adult men (age: 28 ± 4) will be recruited in good physical condition. Participants will be exercised following a 12-hour overnight fast (FAST) and exercised 90 minutes after a meal (FED) to test the temporal sensitivity of the loaded bone to absorbed nutrients. Participants will also attend a breakfast-only arm (without the exercise protocol). Participants will undergo a baseline assessment for health history (PAR-Q). The blood samples will be collected (10ml) and osteogenic response to exercise will be determined by measuring markers of bone formation; P1NP and resorption; CTX-1 and cortisol; marker of physiological and psychological stress. Insulin and glucose measurements will allow to assess the change of concentrations in fasted and fed states.
| Arm | Type | Receives |
|---|---|---|
| Breakfast only | Experimental | Other: Breakfast onlyBreakfast only without the exercise protocol |
| FAST | Experimental | Other: FASTParticipants will be exercised 90 minutes following a 12-hour overnight fast |
| FED | Experimental | Other: FEDParticipants will be exercised 90 minutes after a meal |
Who may qualify
- Ages
- 24 to 32 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male (females excluded to remove the interplay between menstrual cycle and bone turnover)
- Caucasian ethnicity
- Aged 28 ± 4 years
- Are physically active (meet the UK guidelines for physical activity of at least 150 minutes moderate intensity activity and/or at least 75 minutes of vigorous intensity activity per week)
- Otherwise, healthy, able and willing to participate and provide written informed consent
Key exclusion criteria (11 listed)
- Current smokers
- Excessive alcohol consumption (max 15 alcohol units/week)
- Any musculoskeletal injury/disabilities
- Any conditions known to affect bone metabolism (e.g. uncontrolled hyper-/hypothyroidism, hyperparathyroidism, hypo-/hypercalcaemia) or malabsorption syndromes (e.g. Crohn's disease, coeliac disease or inflammatory bowel disease).
- Taking any medication known to affect bone metabolism (such as glucocorticoids or bisphosphonates)
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 |
|---|---|---|
| Breakfast onlyParticipants will attend a breakfast-only arm without the exercise protocol. | Other | Breakfast only |
| FASTParticipants will be exercised for 90 minutes following a 12-hour overnight fast | Other | FAST |
| FEDParticipants will be exercised 90 minutes after a breakfast | Other | FED |
Primary outcome
C-terminal telopeptide of type-1 collagen (CTX-1)
Time frame: Between pre-exercise and 2 hours following the exercise timepoints
The primary endpoint of this study is the change of the bone resorption biomarker C-terminal telopeptide of type-1 collagen (CTX-1) expression
4 secondary outcomes
Procollagen type 1 N-terminal propeptide (P1NP)
Time frame: Between pre-exercise and 2 hours following the exercise timepoints
Cortisol
Time frame: Between pre-exercise and 2 hours following the exercise timepoints
Insulin
Time frame: Between pre-exercise and 2 hours following the exercise timepoints
Glucose
Time frame: Between pre-exercise and 2 hours following the exercise timepoints
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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.
Jasmine Samvelyan, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast only, FAST and FED in people with Osteopenia or Osteoporosis, run by Sheffield Hallam University.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Simon Bowles, PhD (00441142254216, s.bowles@shu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-terminal telopeptide of type-1 collagen (CTX-1) (time frame: Between pre-exercise and 2 hours following the exercise timepoints). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.