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Protein intake not related to mid-thigh muscle area change


- candidate number28388
- NTR NumberNTR6930
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-dec-2017
- Secondary IDsN01-AG-6-2101; N01-AG-6-2103; N01-AG-6-2106; NIA grant R01-AG028050 / National Institute on Aging (NIA)
- Public TitleProtein intake not related to mid-thigh muscle area change
- Scientific TitleDietary protein intake is not associated with 5-year change in mid-thigh muscle cross-sectional area by computed tomography in older adults: the Health, Aging, and Body Composition (Health ABC) Study
- ACRONYM
- hypothesisA higher (animal) protein and a higher essential amino acid intake (especially leucine) are associated with less decline in mid-thigh muscle cross-sectional area over a 5-year period.
- Healt Condition(s) or Problem(s) studiedAged, Protein, Loss of muscle mass
- Inclusion criteriaData from the Health, Aging, and Body Composition (Health ABC) study were used. The Health ABC study is a prospective cohort study and investigates the association among body composition, weight related health conditions, and functional limitations in older adults. Between April 1997 and June 1998, 3075 well-functioning black and white men and women aged 70-79 were enrolled. Participants were recruited from a random sample of white Medicare-eligible residents and all of the black Medicare-eligible residents in the Pittsburgh, PA, and Memphis, TN, metropolitan areas. Subjects were eligible if they reported no difficulties in walking one-fourth of a mile, climbing up 10 steps, or performing basic activities of daily living; no history of active cancer in the 3 y prior to the study; planned to remain in the geographic area for 3y; and were not enrolled in lifestyle intervention trials. All participants gave written informed consent.
- Exclusion criteriaParticipants were excluded from the data-analyses if they had no good quality Computed Tomography (CT) data at year 1 (baseline) and year 6 of the HealthABC study and if they had no or no good quality dietary intake data (with a food frequency questionnaire)
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-apr-1997
- planned closingdate1-jun-2003
- Target number of participants1562
- InterventionsNo intervention: this study is an prospective cohort study
- Primary outcomemid-thigh muscle cross-sectional area by computed tomography
- Secondary outcomenot applicable
- TimepointsYear 1 (baseline): mid-thigh muscle cross-sectional area by CT
Year 6: mid-thigh muscle cross-sectional area by CT
Year 2: dietary intake with a food frequency questionnaire which reflects the intake of the previous year
- Trial web sitehttps://healthabc.nia.nih.gov/
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Amely Verreijen
- CONTACT for SCIENTIFIC QUERIES Amely Verreijen
- Sponsor/Initiator National Institute on Aging (NIA)
- Funding
(Source(s) of Monetary or Material Support)
Intramural Research Program of the NIH, National Institute on Aging, The European Union Horizon 2020 PROMISS Project PRevention Of Malnutrition In Senior Subjects in the EU, grant agreement number: 678732
- Publications
- Brief summary
- Main changes (audit trail)The end date to answer the research question is February 2018. The old database (a prospective cohort study) isn't in a trialregister, so there is no registration number of this trial.
- RECORD29-dec-2017 - 11-jan-2018


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