The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteopenia or Osteoporosis
• Intervention / Treatment: Other: Breakfast only; Other: FAST; Other: FED

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Bowles, PhD; Phone Number: 00441142254216; Email: s.bowles@shu.ac.uk
• Study Contact Backup: Name: Jasmine Samvelyan, PhD; Email: jasmine.samvelyan@aru.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breakfast only; Breakfast only without the exercise protocol	Other: Breakfast only; Participants will attend a breakfast-only arm without the exercise protocol.
Experimental: FAST; Participants will be exercised 90 minutes following a 12-hour overnight fast	Other: FAST; Participants will be exercised for 90 minutes following a 12-hour overnight fast
Experimental: FED; Participants will be exercised 90 minutes after a meal	Other: FED; Participants will be exercised 90 minutes after a breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Between pre-exercise and 2 hours following the exercise timepoints

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procollagen type 1 N-terminal propeptide (P1NP)	The change of the bone formation biomarker procollagen type 1 N-terminal propeptide (P1NP) expression	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	Between pre-exercise and 2 hours following the exercise timepoints
Insulin	The change of concentration in fasted and fed states is assessed	Between pre-exercise and 2 hours following the exercise timepoints
Glucose	The change of concentration in fasted and fed states is assessed	Between pre-exercise and 2 hours following the exercise timepoints

Collaborators and Investigators

• Sponsor: Sheffield Hallam University
• Collaborators: Manchester Metropolitan University; University of Sheffield; Sheffield Teaching Hospitals NHS Foundation Trust; Anglia Ruskin University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: ER52048815

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No