Healthy Elderly
Conditions
Brief summary
The objective of the study is to develop prediction equations for calculating Fat-Free Mass FFM, Total Body Water TBW, Extracellular Water ECW, Visceral Adipose Tissue VAT, total Skeletal Muscle Mass SMM and segmental SMM in a group of elderly. The prediction equations are based on linear regression analysis between the gold standard reference methods Air Displacement Plethysmography ADP, Dual-energy X-ray Absorptiometry DXA, Magnet Resonance Imaging MRI, Deuterium dilution method (D2O) and Sodium Bromide dilution method (NaBr) on the one hand and bioelectrical impedance measurements on the other hand. Multi-frequency bioimpedance is measured for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side using the seca mBCA 515 in standing position and the seca mBCA 525 in standing and lying position.
Interventions
None listed
Sponsors
Seca GmbH & Co. Kg.
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* male and female subjects older than 60 years, * stable medication (no changes during the past 6 months), * subjects need to be able to sign the informed consent and privacy policy
Exclusion criteria
* acute disease * intake of diuretics * wearing of support stockings * edema diagnosed by inspection and palpation of lower limbs * paralysis e.g. after a stroke * neurodegenerative diseases e.g. ALS * tumors in treatment * amputation * electronic implants e.g. pacemaker * under the skin applied injection systems (e.g. insulin pumps or pain pumps) * probands who cannot provide an ICF by themselves * probands who might be dependent from the sponsor or the investigation site * current alcohol abuse * active prostheses * electronic life-support systems, e.g. artificial heart, artificial lung * portable electronic medical devices, e.g. ECG devices or infusion pumps * metallic implants * cochlea implants und heart valves prothesis (e.g. Starr-Edwards-Prothesis) * vessel clips in the brain or medulla applied before 1995 * defeatable pumps * catheter * iron or metallic parts in the body (e.g. shard of metal) * dental braces * magnetic tooth implants * not removeable piercings * extensive tattoos
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Water | 15 minutes | Total body water (TBW) by deuterium (D2O) dilution |
| Extracellular Water | 15 minutes | Extracellular water (ECW) by NaBr dilution |
| Fat-free Mass | 15 minutes | Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight |
| Skeletal Muscle Mass | 1 hour | Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI) |
| Visceral Adipose Tissue | 1 hour | Visceral adipose tissue (VAT) by magnetic resonance imaging MRI |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Elderly 150 elderlies (\>60 years): community dwelling or living in old | 150 |
| Total | 150 |
Baseline characteristics
| Characteristic | Elderly | — |
|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 5.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 88 Participants | — |
| Sex: Female, Male Male | 62 Participants | — |
| weight | 74.3 kg STANDARD_DEVIATION 16.3 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 150 |
| other Total, other adverse events | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 |
Outcome results
Primary
Extracellular Water
Extracellular water (ECW) by NaBr dilution
Time frame: 15 minutes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Elderly | Extracellular Water | 0.74 liter | Standard Deviation 0.04 |
Primary
Fat-free Mass
Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight
Time frame: 15 minutes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Elderly | Fat-free Mass | 2.20 kg | Standard Deviation 0.13 |
Primary
Skeletal Muscle Mass
Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI)
Time frame: 1 hour
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Elderly | Skeletal Muscle Mass | 2.07 kg | Standard Deviation 0.12 |
Primary
Total Body Water
Total body water (TBW) by deuterium (D2O) dilution
Time frame: 15 minutes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Elderly | Total Body Water | 1.85 liter | Standard Deviation 0.11 |
Primary
Visceral Adipose Tissue
Visceral adipose tissue (VAT) by magnetic resonance imaging MRI
Time frame: 1 hour
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Elderly | Visceral Adipose Tissue | 0.92 liter | Standard Deviation 0.05 |