Dose Effect of a Plant Extract on Fatigue
2020년 1월 14일 업데이트: PepsiCo Global R&D
Effects of Two Doses of a Plant Extract on Mental and Physical Fatigue
Test the short-term effects of the acute consumption of two separate beverages containing different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a flavored placebo beverage on mental energy and physical performance
연구 개요
연구 유형
중재적
등록 (실제)
28
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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Georgia
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Athens, Georgia, 미국, 30602
- University of Georgia
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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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 18-49 years of age
- Self-report of good health
- Physical activity requirement: Recreationally active (exercise ≥3 times per week for >30 minutes per session; both cyclists and non-cyclists may enroll)
Exclusion Criteria:
- Under the care of a physician
- Visual impairment that cannot be corrected with glasses or contact lenses
- Inability to perform high intensity exercise (defined perceptually as exercise that feels at least "hard" and this is usually quantified using the Borg 6 to 20 scale. High intensity cycling exercise is defined objectively as exercise causing a high heart rate, defined as a heart rate that is equal to or greater than 70% of heart rate reserve.)
- Inability to adequately perform the cognitive tasks (i.e., cannot complete the task due to -inability to understand instructions or >50% incorrect responses)
- Presence of current or chronic gastrointestinal, sleep or psychiatric disorder
- Pregnant/lactating
- Current smoker
- Report illegal drug use
- Report hypersensitivity to caffeine
- Food allergies/intolerances/sensitivities (including coffee or related foods/beverages/products)
- Current use of dietary supplements, or prescription medication except for oral contraceptives
- Unwillingness to abstain from over the counter medications (e.g. NSAIDS, allergy medications) and caffeine/coffee/foods high in polyphenols for 12 hours prior to the study
- Unwilling to refrain from consuming apple and grapefruit products on study days and 12 hours prior to test days.
- Participation in another clinical trial within the past 30 days or participation in another PepsiCo trial in the past 6 months
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: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Flavored Beverage Mix 1
Flavored still beverage
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Consume one beverage at the beginning of each visit of the cross-over sequence
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실험적: Flavored Beverage Mix 2
Flavored still beverage with polyphenols, concentration 1
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Consume one beverage at the beginning of each visit of the cross-over sequence
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실험적: Flavored Beverage Mix 3
Flavored still beverage with polyphenols, concentration 2
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Consume one beverage at the beginning of each visit of the cross-over sequence
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실험적: Flavored Beverage Mix 4
Flavored still beverage with caffeine
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Consume one beverage at the beginning of each visit of the cross-over sequence
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective mental energy: Cognitive test battery
기간: Baseline and 60 min post treatment
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Changes in subjective measures of mental alertness and mental fatigue through computer administered cognitive test battery domains of short-term memory, attention and mood.
Tasks are word presentation, word recognition, picture presentation, picture recognition, Cognitive Demand Battery (CDB) serial 3 and serial 7 subtraction, and Bakan task/Rapid Visual Information Processing (RVIP).
Performance measures: % correct, % errors and response time in milliseconds.
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for mental alertness
기간: Baseline and 60 min post treatment
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Changes in subjective ratings of mental alertness following computer administered cognitively fatiguing tasks.
Visual Analog Scale (VAS) for mental alertness has the score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for motivation
기간: Baseline and 60 min post treatment
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Changes in subjective ratings of motivation following computer administered cognitively fatiguing tasks.
Visual Analog Scale (VAS) for motivation has the score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for mental fatigue
기간: Baseline and 60 min post treatment
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Changes in subjective ratings of fatigue following computer administered cognitively fatiguing tasks.
Visual Analog Scale (VAS) for fatigue has the score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
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Subjective mental and physical energy: VAS for mental and physical state and trait energy and fatigue (EFS State Scales)
기간: Baseline and 60 min post treatment
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Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks.
Mental and Physical State and Trait Energy and Fatigue Scales (EFS State Scales) consist of 12 VAS items to measure intensity of current feeling of physical energy and fatigue and mental energy and fatigue (3 sub-scales each).
Score range: The 3 items from each sub-scale are summed and scores for each sub-scale range from 0-300 (none to strongest).
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for mood
기간: Baseline and 60 min post treatment
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Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks.
The Bond-Lader test uses 16 Visual Analog Scales (VAS) to measure different aspects of mood, with score range 0-100 for each scale (from absence of feeling to presence of feeling).
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Baseline and 60 min post treatment
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Subjective mental energy: VAS for caffeine symptoms
기간: Baseline and 60 min post treatment
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Changes in subjective ratings of mental alertness, motivation and fatigue following computer administered cognitively fatiguing tasks.
Caffeine symptoms are measured on paper using 8 Visual Analog Scales (VAS) with score range 0-100 (from not at all to extremely).
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Baseline and 60 min post treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical performance
기간: During the last 3 minutes of 23 min high intensity cycling exercise (10 x 1 min work intervals each followed by 1 min rest. No rest after final interval, 3 min max power from minutes 20-23.
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Mean power output in a timed cycling trial following post-treatment cognitive test battery and caffeine symptom VAS.
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During the last 3 minutes of 23 min high intensity cycling exercise (10 x 1 min work intervals each followed by 1 min rest. No rest after final interval, 3 min max power from minutes 20-23.
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Physical Fatigue
기간: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale, score range 0-7, higher score indicates greater feeling of physical fatigue
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Alertness
기간: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale, score range 1-7, higher score indicates greater alertness meaning a greater feeling of energy
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Effort
기간: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale, Borg Ratings of Perceived Exertion (RPE) measures perception of effort, score range 6-20.
Higher score indicates greater effort.
17 or greater generally indicates maximal effort
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Quadriceps muscle pain
기간: After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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Subjective categorical scale with ratio-like properties, scale 0-10 with open-ended option for ratings greater than but proportional to 10. Higher scores indicate greater perception of pain in the quadriceps
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After each of 10 1-minute high intensity cycling intervals separated by 1 min rest and at end of exercise.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Patrick J O'Connor, PhD, University of Georgia
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 (실제)
2019년 1월 29일
기본 완료 (실제)
2019년 12월 6일
연구 완료 (실제)
2019년 12월 6일
연구 등록 날짜
최초 제출
2019년 2월 26일
QC 기준을 충족하는 최초 제출
2019년 3월 8일
처음 게시됨 (실제)
2019년 3월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 1월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 1월 14일
마지막으로 확인됨
2020년 1월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- PEP-1807
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
IPD will be kept securely at U. Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu)
IPD 공유 기간
After publication
IPD 공유 액세스 기준
Open access, upon request
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. .