Menu
Not yet recruiting NCT06550466

The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers

No phase Interventional Osteopenia or Osteoporosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breakfast only, FAST, FED.
Who it may be relevant to
Registry conditions: Osteopenia or Osteoporosis. Basic parameters: 24 years — 32 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Influence of Pre-exercise Feeding on Acute Bone Turnover Biomarkers in Response to Physical Activity in Healthy Participants

Overview

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.

Interventions

  • Other Breakfast only
    Participants will attend a breakfast-only arm without the exercise protocol.
  • Other FAST
    Participants will be exercised for 90 minutes following a 12-hour overnight fast
  • Other FED
    Participants will be exercised 90 minutes after a breakfast

Primary outcome measures

  • C-terminal telopeptide of type-1 collagen (CTX-1) [Time frame: Between pre-exercise and 2 hours following the exercise timepoints]
Secondary outcome measures (4)
  • Procollagen type 1 N-terminal propeptide (P1NP) [Time frame: Between pre-exercise and 2 hours following the exercise timepoints]
  • Cortisol [Time frame: Between pre-exercise and 2 hours following the exercise timepoints]
  • Insulin [Time frame: Between pre-exercise and 2 hours following the exercise timepoints]
  • Glucose [Time frame: Between pre-exercise and 2 hours following the exercise timepoints]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06550466 · ER52048815

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗