Clinical trial NCT06550466: The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers
Official title: The Influence of Pre-exercise Feeding on Acute Bone Turnover Biomarkers in Response to Physical Activity in Healthy Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteopenia or Osteoporosis
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: Anglia Ruskin University
name: University of Sheffield
name: Manchester Metropolitan University
name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2024-08-13
Enrollment: 16
Sex: MALE
Minimum age (years): 24
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: C-terminal telopeptide of type-1 collagen (CTX-1)
timeFrame: Between pre-exercise and 2 hours following the exercise timepoints
Secondary outcomes:
measure: Procollagen type 1 N-terminal propeptide (P1NP)
timeFrame: Between pre-exercise and 2 hours following the exercise timepoints
measure: Cortisol
timeFrame: Between pre-exercise and 2 hours following the exercise timepoints
measure: Insulin
timeFrame: Between pre-exercise and 2 hours following the exercise timepoints
measure: Glucose
timeFrame: Between pre-exercise and 2 hours following the exercise timepoints
Other outcomes:
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