The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers

NCT06550466 | Not Yet Recruiting

• 1 other identifier: ER52048815
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteopenia or Osteoporosis

Outcome Measures

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

  Between pre-exercise and 2 hours following the exercise timepoints

Secondary Outcomes (4)

• Procollagen type 1 N-terminal propeptide (P1NP)

  Between pre-exercise and 2 hours following the exercise timepoints

• Cortisol

  Between pre-exercise and 2 hours following the exercise timepoints

• Insulin

  Between pre-exercise and 2 hours following the exercise timepoints

• Glucose

  Between pre-exercise and 2 hours following the exercise timepoints

Study Arms (3)

Breakfast only

EXPERIMENTAL

Breakfast only without the exercise protocol

Other: Breakfast only

FAST

EXPERIMENTAL

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

Other: FAST

FED

EXPERIMENTAL

Participants will be exercised 90 minutes after a meal

Other: FED

Interventions

Breakfast only OTHER

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

Breakfast only

FAST OTHER

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

FAST

FED OTHER

Participants will be exercised 90 minutes after a breakfast

FED

Eligibility Criteria

• Age: 24 Years - 32 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Anglia Ruskin University: collaborator
• University of Sheffield: collaborator
• Manchester Metropolitan University: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Simon Bowles, PhD

CONTACT

00441142254216; s.bowles@shu.ac.uk

Jasmine Samvelyan, PhD

CONTACT

jasmine.samvelyan@aru.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 13, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08