- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07561619
Yeast Protein for Muscle Mass
Yeast Protein for Muscle Anabolism: A Randomized Controlled Trial
연구 개요
상태
정황
상세 설명
This is a double-blinded randomized clinical trial of a 16-week nutrition intervention with yeast and whey protein in 72 people (36 per group; 18 male and 18 female) between the ages of 18 and 35, recruited from the University of Alberta campus, Edmonton, Canada. Consenting participants will be randomly assigned to one of two groups: whey protein or yeast protein by the study coordinator, who will not collect study outcome measurements or analyze the data.
The goal of the trial is to determine if consumption of 40 g per day of yeast protein produces similar effects to 40 g supplementation with whey protein. It is anticipated that daily yeast protein consumption will show similar gains in muscle mass and improvement in immune function, increased diversity in gut microbiota, and amino acid-derived metabolites compared to whey protein.
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Jianping Wu, PhD
- 전화번호: (780) 492-6885
- 이메일: jwu3@ualberta.ca
연구 장소
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Alberta
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Edmonton, Alberta, 캐나다, T6G 2R3
- The University of Alberta North Campus
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연락하다:
- Jianping Wu, PhD
- 전화번호: (780) 492-6885
- 이메일: jwu3@ualberta.ca
-
수석 연구원:
- Jianping Wu, PhD
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수석 연구원:
- Vera Mazurak, PhD
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수석 연구원:
- Normand Bouleé, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
- Prior resistance training experience (defined as performing resistance exercises >1/week for the past 3 months or longer) to enable them to reach a large training stimulus relatively quickly and to avoid the longer phase of neuromuscular adaptations
- ≥18 years and <35 years of age
Exclusion Criteria:
- Diabetes, musculoskeletal disease, cancer, Crohn's disease, or any other acute or chronic condition that interferes (or the medication prescribed for those conditions) with muscle anabolism.
- Diagnosed with or being treated for heart disease, stroke, high blood pressure 130/80 mmHg or higher
- Pain/discomfort/pressure in the chest during activities of daily living or physical activity
- Pregnant or not on adequate contraception.
- A known hypersensitivity/allergy to ingredients in the supplements.
- Inflammatory bowel diseases
- Enrolment in any other clinical protocol or investigational study that may interfere with study procedures
- Taking antibiotics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 유장 단백질
|
Lower and upper body resistance training exercises 3 times a week for 16 weeks
60g of protein supplement (40g of protein).
Oral administration, 30g during exercise and anytime after exercise, or 30g in the morning and evening if no exercise is performed for a period of 16 weeks.
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실험적: Yeast Protein
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Lower and upper body resistance training exercises 3 times a week for 16 weeks
60g of protein supplement (40g of protein).
Oral administration, 30g during exercise and anytime after exercise, or 30g in the morning and evening if no exercise is performed for a period of 16 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in muscle mass
기간: 16 weeks
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The primary outcome of the study is the change in muscle mass.
It is hypothesized that participants consuming yeast protein will show an increase in appendicular lean mass similar to that observed with whey protein.
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16 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in muscle function, inflammatory biomarkers, oxidative stress markers, gut microbiota and metabolites
기간: 16 weeks
|
The secondary outcomes of the study include changes in muscle function, which will be assessed through one repetition maximum (1RM) testing for both the bench press and leg press.
Additionally, the investigators will evaluate inflammatory biomarkers, specifically plasma cytokines, as well as oxidative stress markers such as glutathione, total antioxidant capacity, and protein carbonyl levels.
The study will also investigate gut microbiota and metabolites.
The investigators hypothesize that the secondary outcomes will show similar effects in participants taking yeast protein compared to those taking whey protein.
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16 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Cermak NM, Res PT, de Groot LC, Saris WH, van Loon LJ. Protein supplementation augments the adaptive response of skeletal muscle to resistance-type exercise training: a meta-analysis. Am J Clin Nutr. 2012 Dec;96(6):1454-64. doi: 10.3945/ajcn.112.037556. Epub 2012 Nov 7.
- Patel S. Emerging trends in nutraceutical applications of whey protein and its derivatives. J Food Sci Technol. 2015 Nov;52(11):6847-58. doi: 10.1007/s13197-015-1894-0. Epub 2015 Jun 9.
- West DWD, Abou Sawan S, Mazzulla M, Williamson E, Moore DR. Whey Protein Supplementation Enhances Whole Body Protein Metabolism and Performance Recovery after Resistance Exercise: A Double-Blind Crossover Study. Nutrients. 2017 Jul 11;9(7):735. doi: 10.3390/nu9070735.
- Norton LE, Wilson GJ, Layman DK, Moulton CJ, Garlick PJ. Leucine content of dietary proteins is a determinant of postprandial skeletal muscle protein synthesis in adult rats. Nutr Metab (Lond). 2012 Jul 20;9(1):67. doi: 10.1186/1743-7075-9-67.
- Joy JM, Lowery RP, Wilson JM, Purpura M, De Souza EO, Wilson SM, Kalman DS, Dudeck JE, Jager R. The effects of 8 weeks of whey or rice protein supplementation on body composition and exercise performance. Nutr J. 2013 Jun 20;12:86. doi: 10.1186/1475-2891-12-86.
- Banaszek A, Townsend JR, Bender D, Vantrease WC, Marshall AC, Johnson KD. The Effects of Whey vs. Pea Protein on Physical Adaptations Following 8-Weeks of High-Intensity Functional Training (HIFT): A Pilot Study. Sports (Basel). 2019 Jan 4;7(1):12. doi: 10.3390/sports7010012.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00156043
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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