The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers

Not Applicable

Not yet recruiting

• Conditions: Osteopenia or Osteoporosis
• Interventions: Other: FAST; Other: Breakfast only; Other: FED

• Registration Number: NCT06550466
• Lead Sponsor: Sheffield Hallam University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13
• Study Start: 2024-10
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FAST	FAST	Participants will be exercised 90 minutes following a 12-hour overnight fast
Breakfast only	Breakfast only	Breakfast only without the exercise protocol
FED	FED	Participants will be exercised 90 minutes after a meal

Primary Outcome Measures

Name	Time	Method
C-terminal telopeptide of type-1 collagen (CTX-1)	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 Outcome Measures

Name	Time	Method
Procollagen type 1 N-terminal propeptide (P1NP)	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
Insulin	Between pre-exercise and 2 hours following the exercise timepoints	The change of concentration in fasted and fed states is assessed
Cortisol	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
Glucose	Between pre-exercise and 2 hours following the exercise timepoints	The change of concentration in fasted and fed states is assessed