About this trial
The main hypothesis is that muscle acts on bone tissue via the secretion of myokines (myostatin, follistatin, irisin). This is based on previous results showing that muscle mass in different patient populations with very different body mass indexes (anorexic or obese patients) is significantly and independently associated with bone mineral density.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Self-reported Caucasian ethnicity (Europe, Middle East, North Africa) only as there is a difference in BMD by ethnicity.
Person affiliated with or benefiting from a social security scheme.
Free, informed consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Disqualifiers
Fragility fracture defined as a spontaneous or low-kinetic fracture (≤ one fall from height).
Early menopause (< 40 years), hysterectomy (complete < 40 years), primary amenorrhea (absence of menstruation before 15 years), current amenorrhea of more than 3 months without contraceptive if the patient is less than 40 years old.
Patients on treatments: prolonged corticosteroid therapy > 3 months or > 1 g (cumulative dose).
Immobilization of more than 3 months, less than 12 months old.
Trial design
Single group
Treatments tested in this trial
Blood sample
Diagnostic test36 ml of blood in 3 x 7 ml dry tubes, 1 x 5 ml EDTA tube, 1 x 5 ml heparinized tube, 1 x 5 ml anti-protease tube)
Saliva sample
Diagnostic test5 ml of saliva will be taken.
Grip test
Diagnostic testThe grip strength of the dominant arm will be measured with the participant in a standing position, with the arm close to the body and the elbow at 90◦ flexion, while the non-dominant arm will be positioned alongside the body. Three measurements will be taken for the dominant hand, and the mean value will be calculated and used for analysis. One minute is allowed between each repetition, to avoid muscle fatigue. Dynamometer quality control is ensured by regularly checking known resistance values.
MicroFET2® maximum isometric force test
Other interventionThe microFET2 device is used to test isometric force. The microFET2 dynamometer is battery-powered and ergonomically designed to fit in the palm of the hand. The system is microprocessor-controlled to provide accurate, repeatable muscle force readings. The microFET Clinical software automatically performs calculations and validity tests, and allows graphs to be generated from the data, enabling reports of different patient tests to be compared
Maximum isometric knee extension bench test.
Other interventionThe maximal isometric knee extension strength test on a specially-adapted strength bench consists in performing 3 maximal contractions with 1 minute's rest between each test.
The SPPB (Short Physical Performance Battery)
Other interventionBattery of tests comprising a balance test, a walking speed test and a chair-lift test
The 6-minute walking test.
Other interventionMuscular function will be determined by the 6-minute walk test to assess aerobic endurance. Participants will be asked to walk for 6 min as fast as possible on a shuttle track. The distance (m) covered in 6 min will be measured. Walking speed (m/s) will be calculated as the distance (m) covered in 6 min. A walking speed \<0.8 m/s has been defined as a low value.
Segmental impedancemetry examination.
Other interventionSegmental impedancemetry involves measuring body composition using the body's resistance to the passage of a low-intensity electric current. This test is harmless to the body.
Indirect calorimetry test.
Other interventionAn Indirect calorimetry is the standard method for measuring energy expenditure at rest. It is based on the principle that the human body burns nutrients using O2 and producing CO2.
Fardellone's questionnaire
Other interventionCompletion of a questionnaires on calcium intake (Fardellone)
ONAPS questionnaire
Other interventionThe ONAPS questionnaire contains questions on physical activity and sedentariness
Dietary intake.questionnaire
Other interventionThe dietary intake questionnaire contains questions regarding the person's eating habits - how many meals a day, where they eat, whether they eat alone, what foods they eat/drink and whether they are following a particular diet and, if so, the reasons why.
Treatment groups
Trial outcomes
Primary outcomes
Myostatin
Plasma concentration of myostatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Follistatin
Plasma concentration of follistatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Irisin
Plasma concentration of irisin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Bone Mineral Density
Bone densitometry using X-ray absorptiometry (DXA) measured in g/cm²
Secondary outcomes
Leptin
Plasma concentration of leptin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Adiponecotin
Plasma concentration of adiponecotin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Fat mass
Impedencemetry, measured in Kg
Bone mineral density: impedencemetry
Bone densitometry will be measured by impedencemetry in g/cm²
Other outcomes
Creation of a blood bank
Blood samples will be stored at the biological resource centers of Nîmes and Montpellier University Hospitals. As soon as the samples have been taken, the tubes are left at room temperature for about 5 minutes to coagulate (only dry tubes will coagulate). They are then centrifuged at 3800 rpm for 20 minutes at 4°C, aliquoted into cryotubes (volume 600 µl) and frozen as quickly as possible at -80°C.
Creation of a saliva bank
The saliva sample is taken at least 60 minutes after brushing the teeth or taking medication and at least 10 minutes after drinking (water). The subject must place the cotton swab in the mouth without touching it and leave it in the mouth for at least 3 minutes until he or she can no longer avoid swallowing the saliva produced. The subject then returns the inhibited saliva swab to the suspended container and seals the tube with the stopper. The tube was then centrifuged at 3800 rpm for 20 minutes at 4°C. The clear saliva (without residue) thus extracted is aliquoted into cryotubes (volume 600 µl) and frozen as quickly as possible at -80°C. Saliva samples will be stored at the biological resource centers of Nîmes and Montpellier University Hospitals.
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