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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| elderly | 150 elderlies (>60 years): community dwelling or living in old |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Body Water | Total body water (TBW) by deuterium (D2O) dilution | 15 minutes |
| Extracellular Water | Extracellular water (ECW) by NaBr dilution | 15 minutes |
| 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 | 15 minutes |
| Skeletal Muscle Mass | Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI) | 1 hour |
| Visceral Adipose Tissue | Visceral adipose tissue (VAT) by magnetic resonance imaging MRI | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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150 elderlies (>60 years): community dwelling or living in old nursing homes
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Human Nutrition and Food Science | Kiel | 24105 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36933351 | Derived | Enderle J, Reljic D, Jensen B, Peine S, Zopf Y, Bosy-Westphal A. Normal values for body composition in adults are better represented by continuous reference ranges dependent on age and BMI. Clin Nutr. 2023 May;42(5):644-652. doi: 10.1016/j.clnu.2023.03.006. Epub 2023 Mar 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Elderly | 150 elderlies (>60 years): community dwelling or living in old people's homes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elderly | 150 elderlies (>60 years): community dwelling or living in old |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Body Water | Total body water (TBW) by deuterium (D2O) dilution | Posted | Least Squares Mean | Standard Deviation | liter | 15 minutes |
|
|
2 days (During the presence in the research facility. 1 day for all measurements except MRI, 1 day for MRI.)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elderly | 150 elderlies (>60 years): community dwelling or living in old | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Klückmann | seca gmbh & co. kg | 040200000232 | kristin.klueckmann@seca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2019 | Oct 6, 2021 | Prot_SAP_000.pdf |
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whole blood
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| weight | Mean | Standard Deviation | kg |
|
|
| Primary | Extracellular Water | Extracellular water (ECW) by NaBr dilution | Posted | Least Squares Mean | Standard Deviation | liter | 15 minutes |
|
|
|
| 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 | Posted | Least Squares Mean | Standard Deviation | kg | 15 minutes |
|
|
|
| Primary | Skeletal Muscle Mass | Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI) | Posted | Least Squares Mean | Standard Deviation | kg | 1 hour |
|
|
|
| Primary | Visceral Adipose Tissue | Visceral adipose tissue (VAT) by magnetic resonance imaging MRI | Posted | Least Squares Mean | Standard Deviation | liter | 1 hour |
|
|
|
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
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