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临床试验/NCT06550466
NCT06550466尚未招募不适用

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

Sheffield Hallam University0 个研究点目标入组 16 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
16
主要终点
C-terminal telopeptide of type-1 collagen (CTX-1)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
24 Years 至 32 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Breakfast only

Experimental

Breakfast only without the exercise protocol

干预措施: Breakfast only (Other)

FAST

Experimental

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

干预措施: FAST (Other)

FED

Experimental

Participants will be exercised 90 minutes after a meal

干预措施: FED (Other)

结局指标

主要结局

C-terminal telopeptide of type-1 collagen (CTX-1)

时间窗: 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

次要结局

  • Insulin(Between pre-exercise and 2 hours following the exercise timepoints)
  • 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)
  • Glucose(Between pre-exercise and 2 hours following the exercise timepoints)

研究者

申办方类型
Other
责任方
Sponsor

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