Bone Metabolism in Exercising WOMEN: Influence of Low Energy Availability and Sex Hormone Fluctuations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Concentrations of other biochemical biomarkers
Study Overview
Brief Summary
The main goal of this study is to examine how sex hormones and low energy availability affect the concentrations of bone remodelling markers at rest and after a running protocol. The research questions to be addressed are:
1: Does the ovarian hormone profile influence serum bone marker concentrations in women exercising resting and in response to to exercise?
- Are there differences in response to low energy availability in bone marker concentrations between eumenorrhoeic female athletes and oral contraceptive users?
3: Is the response of bone markers affected by different exercise stimuli: endurance or aerobic endurance?
4: Do bone markers return to baseline levels after 24 hours of high energy availability diet after 6 days of low energy availability?
Detailed Description
To achieve the aim of the study, there will be two experimental groups - e.g. eumenorrhoeic females and oral contraceptive users - who, after screening, will be randomly assigned to a low- or high-energy diet. After 6 days on this diet, the participant will undergo an intervallic running protocol and blood samples will be taken before and after the test. The following month the participant will do the other type of diet.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be healthy and between 18 and 30 years old.
- •Engage in endurance sports that involve running (such as athletics, running, triathlon, trail running, etc.) for 3 to 12 hours per week..
- •Eumenorrheic females with regular menstruation at least 6 months prior to the study.
- •Monophasic oral contraceptive users at least 6 months prior to the study.
Exclusion Criteria
- •Amenorrheic females.
- •Pregnant females.
- •Affected by any disorder related to the hypothalamo-pituitary-ovarian axis.
- •Having suffered a bone fracture in the year before the study.
- •Taking any medication or supplements that affect bone metabolism.
Arms & Interventions
Eumhenorreic females
Intervention: Low energy availability (Other)
Eumhenorreic females
Intervention: High energy availability (Other)
Oral concetraceptive users
Intervention: Low energy availability (Other)
Oral concetraceptive users
Intervention: High energy availability (Other)
Outcomes
Primary Outcomes
Concentrations of other biochemical biomarkers
Time Frame: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise
Concentrations of Triiodothyronine (T3), Albumin, Sex Hormone Binding Globulin (SHBG), etc. measured in serum
Concentration of bone metabolism biomarkers
Time Frame: immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise
Concentration of procollagen type I N-propeptide (P1NP), cross-linking telopeptide of type I collagen (βCTX-1), paratyroid hormone, calcium, sclerostin, osteoprotegin, osteocalcin, bone alkaline phospatase, Receptor Activator for Nuclear Factor κ B Ligand (RANKL) measured in serum samples.
Concentrations of sex hormones
Time Frame: Immediately pre-exercise and immediately, 15 minutes and 24 hours post-exercise
Concentrations of 17β-Oestradiol and Progesterone measured in serum.
Bone mineral density
Time Frame: At the screening phase
Total, lumbar spine and femoral neck bone mineral density (g/cm\^2) measured by dual x-ray absorptiometry
Secondary Outcomes
- Training status variables(At the screening phase)
- Body composition variables(Immediately pre- and post-nutritional intervention (bioimpedance) and DXA at the screening)
- Body metrics(Measured at the screening phase)
Investigators
ANA BELEN PEINADO LOZANO
Principal Investigator
Universidad Politecnica de Madrid