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NCT Number: NCT06550466

The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers

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.

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Key information

Conditions

Osteopenia or Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

24 year–32 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Breakfast only

Other

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

FAST

Other

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

Fed

Other

Participants will be exercised 90 minutes after a breakfast

Primary outcomes

  1. 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

Secondary outcomes

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

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

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

  2. Cortisol

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

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

  3. Insulin

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

    The change of concentration in fasted and fed states is assessed

  4. Glucose

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

    The change of concentration in fasted and fed states is assessed

Study contacts

Contact information is provided by the study sponsor or research team.

Jasmine Samvelyan, PhD

CONTACT

[email protected]

Simon Bowles, PhD

CONTACT

[email protected]

00441142254216

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Collaborators

  • Anglia Ruskin University
  • Manchester Metropolitan University
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • University of Sheffield

Registry information

Official study title

The Influence of Pre-exercise Feeding on Acute Bone Turnover Biomarkers in Response to Physical Activity in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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