The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers

Sheffield Hallam University

Status: Not yet enrolling

Conditions: Osteopenia or Osteoporosis

Treatments: Other: FED; Other: Breakfast only; Other: FAST

Study type: Interventional

Funder types: Other

Identifiers

NCT06550466

ER52048815

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: Male

Ages: 24 to 32 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Breakfast only

Experimental group

Description:

Breakfast only without the exercise protocol

Treatment:

Other: Breakfast only

FAST

Experimental group

Description:

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

Treatment:

Other: FAST

FED

Experimental group

Description:

Participants will be exercised 90 minutes after a meal

Treatment:

Other: FED