Bone Resorption Clinical Trial
Official title:
The Effects of Short-term Low Energy Availability and Low Repetition High Impact Jumping on Markers of Bone Formation and Resorption in Young Females
NCT number | NCT04790019 |
Other study ID # | R20-P052 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2020 |
Est. completion date | June 30, 2022 |
Verified date | February 2023 |
Source | Loughborough University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Osteoporosis is worldwide health epidemic categorized by poor bone health, primarily diagnosed by low bone mineral density, and costs healthcare systems billions every year. Athletes and exercising people who expend large amounts of energy in physical activity, or restrict diet in order to lose weight, are at risk of low energy availability. This is when an individual fails to match their exercise energy demand with a appropriate dietary intake in order to maintain optimal physiological function; which can lead to low bone mineral density, osteoporosis both early and later in life and an increased risk of injury. Runners are particularly susceptible to stress fracture in response to low energy availability due to repetitive ground impact. Research shows that as little as five days low energy availability significantly reduces bone formation, and significantly increases bone resorption, in physically active women. The ideal solution is to restore energy availability; however, this is often very difficult during periods of intense training and conflicts with the goal of weight loss. Therefore, there is a need to develop an alternative tool to protect bone health. It is critical that any exercise intervention does not further reduce energy availability as previous research shows that this accelerates bone loss rather than prevents it. Low repetition high impact jumping exercise is highly beneficial to bone health and has been shown to improve bone structure when used as a long-term intervention in energy replete states. It takes very little time to complete and uses a very small amount of energy. However, no study to date has examined the effects of such an intervention during low energy availability. The current study will investigate whether low repetition high impact jumping prevents or reduces the reduction in bone formation and the increase in bone resorption experienced during five days of low energy availability and findings will have implications on athletic and recreational training recommendations in order to protect bone health.
Status | Completed |
Enrollment | 19 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | To take part in this study, the following inclusion criteria must be met: - Menstrual cycles that are between 21 - 35 days in length for at least the previous three cycles - Regular length of menstrual cycle (less than six days difference between cycles) for at least the previous three cycles - Body mass index between 18.5 - 30 kg.m squared - Weight stable for the past three months and not currently dieting Participants will not be able to take part in this study if any of the following exclusion criteria are met: - Smoker - Pregnant - Vegan - Have used hormonal contraception at any point within the previous three months - Regularly engage in >3 vigorous, or >5 moderate, exercise sessions a week - Compete regularly in a high or multi-directional impact sport at national level or higher - Have sustained a bone injury within the previous twelve months - Have sustained any injury within the past six months that restricted their ability to exercise - Taken hormone replacement therapy (HRT) at any point during the past three months - Have been previously diagnosed with an eating disorder - Have taken any medications (other than vitamin or mineral supplements) known to effect bone metabolism within the previous three months (e.g. glucocorticoids, anticonvulsants or anabolic steroids) - Have previously been diagnosed with a medical condition known to impact bone health (e.g. hypothyroidism, hyperthyroidism, diabetes mellitus, hypercortisolism and renal or gastrointestinal disease) - Have previously been diagnosed with a pathology known to impact menstrual function (e.g. primary ovarian insufficiency, hyperprolactinemia, thyroid dysfunction, polycystic ovarian syndrome and any other conditions of androgen excess) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Mark Hutson | Loughborough | Leicestershire |
Lead Sponsor | Collaborator |
---|---|
Loughborough University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in blood pro-peptide of type 1 collagen (P1NP) concentration | P1NP is a marker of bone resorption and it will be measured during the fasted state | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Primary | Change in blood ß-carboxyl-terminal cross-linked telopeptide of type 1 collagen (ß-CTx) concentration | ß-CTx is a marker of bone formation and it will be measured during the fasted state | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in blood 17ß-oestradiol concentration | 17ß-oestradiol is a reproductive hormone that fluctuates during the menstrual cycle and is involved in the regulation of bone resorption | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in blood triiodothyronine (T3) concentration | T3 is a thyroid hormone that has previously been shown to decrease in response to low energy availability has been proposed as a useful marker of low energy availability | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in blood ß-hydroxybutyrate (ß-OHB) concentration | ß-OHB is a ketone body produced during periods of energy and/or carbohydrate restriction | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in blood calcium concentration | Calcium is a micro-nutrient involved in the regulation of bone (re)modelling and may change in response to low energy availability | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in blood magnesium concentration | Magnesium is a micro-nutrient involved in the regulation of bone (re)modelling and may change in response to low energy availability | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in blood phosphorus concentration | Phosphorus is a micro-nutrient involved in the regulation of bone (re)modelling and may change in response to low energy availability | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in resting metabolic rate (RMR) | This is amount of energy used by the body at rest and is measured via indirect calorimetry compared to RMR predicted using previously validated equations. It has been proposed that a ratio of <0.9 may be used as a surrogate marker of energy deficiency | From the morning of the first day of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in ratio of measured:predicted resting metabolic rate (RMR) | This is the ratio of RMR measured via indirect calorimetry compared to RMR predicted using previously validated equations. It has been proposed that a ratio of <0.9 may be used as a surrogate marker of energy deficiency | From the morning of the first day of dietary provision to the same time on the morning following the final day of dietary provision (five days later), in each condition | |
Secondary | Change in blood plasma volume (estimated using haemoglobin concentration and haematocrit) | Plasma volume is a measure of the proportion of blood that is made up of plasma. It has been shown to change in response to low energy availability and may influence the concentrations of primary measures independent of low energy availability, per se. | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in heart rate variability | It has been proposed that low energy availability impairs cardiovascular function and heart rate variability is a measure of the variation in time between each heart beat | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in the spectral density of heart rate variability in low and high frequency bands | It has been proposed that low energy availability impairs cardiovascular function and spectral analysis of heart rate variability provides information on the function of sympathetic and parasympathetic regulation of heart rate | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in aortic stiffness | It has been proposed that low energy availability impairs cardiovascular function and aortic stiffness is estimated via measurement of arterial stiffness at the wrist | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in forearm resting blood flow | It has been proposed that low energy availability impairs cardiovascular function and forearm blood flow is a marker of cardiovascular function that can be measured using plethysmography | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in forearm peak blood flow | It has been proposed that low energy availability impairs cardiovascular function and peak forearm blood flow is a marker of cardiovascular function that can be measured using plethysmography | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in body weight | Body weight could be expected to decrease in response to caloric restriction and will therefore be measured and can be used to indicate adherence to dietary provision | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in fat-free mass | Fat-free mass could be expected to decrease in response to caloric restriction and will therefore be measured and can be used to indicate adherence to dietary provision | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition | |
Secondary | Change in baroreflex sensitivity | It has been proposed that low energy availability impairs cardiovascular function and baroreflex sensitivity is a marker of the functionality of the system of cross-talk between cardiac control and blood pressure | of dietary provision to the same time on the morning following the final day of dietary provision (three days later), in each condition |
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