- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07594444
Whey Protein and Adaptogenic Supplementation in Physically Active Females
2026년 6월 3일 업데이트: Olivia Charlotte Coope, Sports Performance and Applied Research in Trials and Analysis
Whey Protein and Adaptogenic Herb Supplementation in Physically Active Females: A Randomised Controlled Trial
The goal of this clinical trial is to learn whether whey protein or plant protein supplements, with or without an adaptogenic herb blend, can improve strength, recovery, stress, and wellbeing in active females. The adaptogenic blend contains ashwagandha root extract and shatavari root extract.
The main questions the study aims to answer are:
- Do whey protein and plant protein supplements improve muscle strength and recovery in physically active females?
- Does adding ashwagandha and shatavari improve stress, recovery, sleep, and wellbeing compared with protein alone?
- Are there differences between whey protein and plant protein when combined with the adaptogenic blend?
Researchers will compare four supplement groups:
- Whey protein
- Whey protein with ashwagandha and shatavari
- Plant protein
- Plant protein with ashwagandha and shatavari
Participants will:
- Take their assigned supplement daily for 6 weeks
- Attend testing sessions before and after the intervention
- Complete questionnaires about recovery, sleep, stress, soreness, and digestive health
- Provide saliva samples to measure stress, hormone, immune, and inflammation markers
- Complete muscle strength tests, including handgrip strength and push-up testing
- Complete a 24-hour dietary recall. The study includes physically active females aged 18 to 45 years who regularly participate in structured training.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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East Sussex
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Brighton, East Sussex, 영국
- 모병
- Strength and Nutrition Ltd
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연락하다:
- Olivia C Coope, PhD(c)
- 전화번호: 07882461098
- 이메일: livcwalker@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Female, aged 18-45 years
- Currently participating in regular structured athletic or physical training (≥3 sessions per week)
- Free from musculoskeletal injury that would prevent testing
- Willing to maintain usual diet and training habits during the study
- Not currently using protein supplements or adaptogenic supplements
Exclusion Criteria:
- Pregnant, breastfeeding, or planning pregnancy during the study period
- Known allergy or sensitivity to dairy, pea protein, pumpkin seed, chia seed, ashwagandha, shatavari, or nightshades
- Current use of prescribed medication that may interact with the supplements
- Thyroid disorders, autoimmune conditions, hormone-sensitive conditions, or other medical conditions that may be affected by supplementation
- Diagnosed eating disorder or condition affecting protein metabolism
- Current musculoskeletal injury preventing participation in testing
- Current use of other protein supplements or adaptogens
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Whey Protein + Adaptogenic Blend
Participants will consume a whey protein supplement containing ashwagandha KSM-66® (250 mg) and shatavari SRI-81™ (300 mg) daily for 6 weeks.
Assessments will be conducted at baseline and post-intervention.
|
Participants will consume a whey protein supplement containing ashwagandha KSM-66® root extract (250 mg) and shatavari SRI-81™ root extract (300 mg) daily for 6 weeks.
Supplements will be provided in identical blank tubs.
Participants will maintain usual diet and training habits during the study.
다른 이름들:
|
|
실험적: Plant Protein + Adaptogenic Blend
Participants will consume a plant-based protein supplement containing ashwagandha KSM-66® (250 mg) and shatavari SRI-81™ (300 mg) daily for 6 weeks.
Assessments will be conducted at baseline and post-intervention.
|
Participants will consume a plant-based protein supplement containing ashwagandha KSM-66® root extract (250 mg) and shatavari SRI-81™ root extract (300 mg) daily for 6 weeks.
Supplements will be provided in identical blank tubs.
Participants will maintain usual diet and training habits during the study.
다른 이름들:
|
|
활성 비교기: Whey protein
Participants will consume a whey protein supplement daily for 6 weeks.
Assessments of muscle strength, recovery, stress, wellbeing, dietary intake, and salivary biomarkers will be conducted at baseline and post-intervention.
|
Participants will consume a whey protein supplement daily for 6 weeks.
The supplement will be provided in identical blank tubs.
Participants will be instructed to maintain their usual diet and training habits throughout the intervention period.
다른 이름들:
|
|
활성 비교기: Plant protein
Participants will consume a plant-based protein supplement daily for 6 weeks.
Assessments of muscle strength, recovery, stress, wellbeing, dietary intake, and salivary biomarkers will be conducted at baseline and post-intervention.
|
Participants will consume a plant-based protein supplement daily for 6 weeks.
The supplement will be provided in identical blank tubs.
Participants will be instructed to maintain their usual diet and training habits throughout the intervention period.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Salivary Cortisol Concentration
기간: Baseline and Week 6
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Change in salivary cortisol concentration from baseline to post-intervention following 6 weeks of whey protein or plant protein supplementation with or without an adaptogenic herb blend containing ashwagandha KSM-66® and shatavari SRI-81™.
Results will be reported in ng/mL.
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Baseline and Week 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Handgrip Strength
기간: Baseline and Week 6
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Change in maximal handgrip strength measured using a CAMRY dynamometer from baseline to post-intervention.
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Baseline and Week 6
|
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Upper Body Muscular Endurance
기간: Baseline and Week 6
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Change in upper body muscular endurance assessed using the 90-degree push-up test protocol from baseline to post-intervention.
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Baseline and Week 6
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Perceived Gastrointestinal Health
기간: Baseline and Week 6
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Change in gastrointestinal symptoms and digestive comfort assessed using a gastrointestinal distress questionnaire.
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Baseline and Week 6
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Dietary Intake
기간: Baseline and Week 6
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Dietary intake assessed using a 24-hour dietary recall to evaluate habitual nutritional intake during the study period.
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Baseline and Week 6
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Perceived Recovery and Wellbeing
기간: Baseline and Week 6
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Participants will complete the Hooper Index Questionnaire, which assesses four domains: sleep quality, fatigue, stress, and muscle soreness.
Each domain is rated on a 10-point Likert scale ranging from 1 to 10, with total scores ranging from 4 to 40.
Higher scores indicate poorer wellbeing and recovery status, whereas lower scores indicate better perceived wellbeing and recovery.
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Baseline and Week 6
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Salivary DHEA-S Concentration
기간: Baseline and Week 6
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Salivary DHEA-S concentration will be measured from saliva samples using enzyme-linked immunosorbent assay (ELISA) techniques.
Results will be reported in ng/mL.
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Baseline and Week 6
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Salivary Oestradiol Concentration
기간: Baseline and Week 6
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Salivary oestradiol concentration will be measured from saliva samples using ELISA.
Results will be reported in pg/mL.
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Baseline and Week 6
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Salivary Secretory Immunoglobulin A (sIgA) Concentration
기간: Baseline and Week 6
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Salivary secretory immunoglobulin A (sIgA) concentration will be measured from saliva samples using ELISA.
Results will be reported in µg/mL.
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Baseline and Week 6
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Salivary C-reactive Protein Concentration
기간: Baseline to Week 6
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Salivary C-reactive protein will be measured from saliva samples using ELISA.
Results will be reported in pg/mL.
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Baseline to Week 6
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2026년 8월 12일
연구 완료 (추정된)
2026년 9월 20일
연구 등록 날짜
최초 제출
2026년 5월 12일
QC 기준을 충족하는 최초 제출
2026년 5월 12일
처음 게시됨 (실제)
2026년 5월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 3일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ASH-WHEY-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data (IPD) will not be shared with other researchers.
Data collected in this study will be anonymised and retained only for the duration of analysis before permanent deletion, in accordance with the study protocol, participant consent, and UK GDPR requirements.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .