NCT04028648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 22, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2020

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

February 14, 2022

Completed
Last Updated

February 14, 2022

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

September 14, 2018

Results QC Date

October 6, 2021

Last Update Submit

November 30, 2021

Conditions

Healthy Elderly

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

elderly

150 elderlies (\>60 years): community dwelling or living in old

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

150 elderlies (\>60 years): community dwelling or living in old nursing homes

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition and Food Science

Kiel, 24105, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36933351DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

Results Point of Contact

Title
Kristin Klückmann
Organization
seca gmbh & co. kg
kristin.klueckmann@seca.com
040200000232

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2018

First Posted

July 22, 2019

Study Start

January 22, 2019

Primary Completion

January 8, 2020

Study Completion

January 8, 2020

Last Updated

February 14, 2022

Results First Posted

February 14, 2022

Record last verified: 2021-10

Locations

DE(1)