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Not yet recruitingNCT06550466Updated Aug 13, 2024

The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers

An interventional study of Breakfast only and FAST in Osteopenia or Osteoporosis, sponsored by Sheffield Hallam University. Not yet recruiting. Open to male participants aged 24 Years to 32 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Sheffield Hallam University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
24 Years to 32 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Osteopenia or Osteoporosis
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 16 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Sheffield Hallam University is the lead sponsor of 44 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 32 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Breakfast only

    Breakfast only without the exercise protocol

    Other: Breakfast only

  • Experimental
    FAST

    Participants will be exercised 90 minutes following a 12-hour overnight fast

    Other: FAST

  • Experimental
    FED

    Participants will be exercised 90 minutes after a meal

    Other: FED

Interventions

  • OtherBreakfast only

    Participants will attend a breakfast-only arm without the exercise protocol.

  • OtherFAST

    Participants will be exercised for 90 minutes following a 12-hour overnight fast

  • OtherFED

    Participants will be exercised 90 minutes after a breakfast

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Between pre-exercise and 2 hours following the exercise timepoints

Secondary outcomes

  1. Procollagen type 1 N-terminal propeptide (P1NP)

    The change of the bone formation biomarker procollagen type 1 N-terminal propeptide (P1NP) expression

    Time frame: Between pre-exercise and 2 hours following the exercise timepoints

  2. Cortisol

    Markerof physiological and psychological stress is assessed and because of its promotion of bone resorption

    Time frame: Between pre-exercise and 2 hours following the exercise timepoints

  3. Insulin

    The change of concentration in fasted and fed states is assessed

    Time frame: Between pre-exercise and 2 hours following the exercise timepoints

  4. Glucose

    The change of concentration in fasted and fed states is assessed

    Time frame: Between pre-exercise and 2 hours following the exercise timepoints

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 30, 2024

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06550466
Lead sponsor
Sheffield Hallam University
Collaborators
Anglia Ruskin University, University of Sheffield, Manchester Metropolitan University, Sheffield Teaching Hospitals NHS Foundation Trust
Responsible party
Sponsor
First posted
Aug 13, 2024
Start date
Oct 2024 (estimated)
Primary completion
Mar 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Aug 13, 2024

Study contacts

Simon Bowles, PhD
Contact
s.bowles@shu.ac.uk
00441142254216
Jasmine Samvelyan, PhD
Contact
jasmine.samvelyan@aru.ac.uk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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