- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01578733
Determination of Protein Requirement in Elderly Female Subjects 65-75 Yrs Old
Use of Indicator Amino Acid Oxidation Technique to Determine Protein Requirement of Elderly Female Subjects 65-75 Yrs Old
Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements.
The current DRI requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).
Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population.
The goal of this study therefore is to measure the protein requirement of female elderly subjects between the ages of 65 - 70 years using the IAAO technique.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G1X8
- The Hospital for Sick Children
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy elderly females between the ages of 65 to 75 and >75 years
- Willingness to participate in the study
- Females without a chronic disease or acute illness that could affect protein and AA metabolism eg, diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
- Females with hypertension if well controlled by medications
Exclusion Criteria:
- Presence of disease known to affect protein and AA requirement and synthesis like diabetes, cancer, liver o kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
- On medications known to affect protein and amino acid metabolism like e.g. steroids.
- Significant weight loss during the past month.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: protein intake
different levels of protein intake
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•Protein intakes will be varied at 0.2, 0.5, 0.7, 0.9,1.0,
1.2, 1.5, 1.8g, 2.0g/kg/day
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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13CO2 production
기간: Study Day 3
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Urine and breath samples will be collected on day 3 of the experiment in order to determine to rate of production of 13CO2, phenylalanine flux and oxidation.
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Study Day 3
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 0019850580-A
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
protein intake.에 대한 임상 시험
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Prof. Dr. med. Andreas F. H. PfeifferEuropean Union완전한
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Ruijin HospitalChengdu Women's and Children's Central Hospital; Zhengzhou Children's Hospital, China; Wuhan...아직 모집하지 않음유아의 경미한 알레르기 증상 | 영아 섭식 불내성
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University of HohenheimUniversity Hospital Tuebingen완전한