A Clinical Trial to Evaluate the Effects of Two Supplements on Cognitive Function, Cognitive Performance, and Mood
This study evaluates the effects of two liquid dietary supplements, BrainJuice Peach Mango (test product one) and BrainJuice ACTIVE Pomegranate Acai (test product two), on cognitive function, cognitive performance, and mood in healthy adults aged 18-57 who report concerns in these areas. The trial is a six-week, single-arm, open-label, virtual study enrolling 30 participants.
Participants will consume test product one (2.5 oz once daily) during Weeks 1 and 2, undergo a washout period during Weeks 3 and 4, and then consume test product two (2.5 oz once daily) during Weeks 5 and 6. Cognitive function will be assessed via standardized computerized cognitive assessments at Baseline, Week 2, Week 4, and Week 6, while perceptions of cognitive function, cognitive performance, and mood will be captured through self-reported questionnaires at Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Nevada
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Las Vegas, Nevada, 미국, 89101
- Citruslabs
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Be male or female
- Be aged 18-57
- Anyone experiencing concerns regarding all of the following over the past four weeks: Cognitive Function, Cognitive Performance, and Mood
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease
- If taking oral over-the-counter supplements or herbal remedies targeted at cognitive function, cognitive performance, or mood, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration
- Anyone who is a regular caffeine consumer without a history of caffeine sensitivity or intolerance
- Willing to maintain the same diet and exercise regimen consistently throughout the study duration
- Willing to limit caffeine consumption to one additional serving of caffeine outside of the test product i.e. one cup of brewed coffee (~100 mg), one matcha (~60 mg), two shots of espresso (~120 mg), or one cup of caffeinated tea (~50 mg)
- Resides in the United States
- Has access to a computer or tablet device
Exclusion Criteria:
- Anyone with pre-existing chronic conditions, including but not limited to oncological, uncontrolled hypertension (high blood pressure) or hypotension (low blood pressure), heart disease, diabetes and psychiatric disorders
- History of neurodegenerative disease (e.g., Alzheimer's, Parkinson's), history of traumatic brain injury (including concussions), stroke, epilepsy, or uncontrolled migraine
- History of mood disorders, such as depression, bipolar disorder, or seasonal affective disorder
- History of sleep disorders, such as insomnia, narcolepsy, or sleep apnea
- Anyone with a job that involves shift work that may be overnight or night hours
- Planning on introducing any products or any new forms of prescription medication or supplements that target cognitive function, cognitive performance, or mood, for the study duration
- Anyone with any allergies or sensitivities to any of the study product ingredients
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
- Anyone unwilling to follow the study protocol
- Anyone with a history of substance abuse
- Anyone who is currently a smoker or has been a smoker in the past 3 months
- Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: BrainJuice Supplement
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All participants consume BrainJuice Peach Mango (test product one, 2.5 oz once daily) during Weeks 1 and 2, followed by a washout period during Weeks 3 and 4 with no test product, followed by BrainJuice ACTIVE Pomegranate Acai (test product two, 2.5 oz once daily) during Weeks 5 and 6.
There is no comparator or placebo arm.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Cognitive Assessment Score (Polygons)
기간: Baseline, Week 2, Week 4, and Week 6
|
Mean change in Polygons processing test score from Baseline, measured via computerized cognitive assessment
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Baseline, Week 2, Week 4, and Week 6
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Change in Cognitive Assessment Score (Double Trouble)
기간: Baseline, Week 2, Week 4, and Week 6
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Mean change in Double Trouble selective attention and processing speed test score from Baseline, measured via computerized cognitive assessment
|
Baseline, Week 2, Week 4, and Week 6
|
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Change in Cognitive Assessment Score (Feature Match)
기간: Baseline, Week 2, Week 4, and Week 6
|
Mean change in Feature Match focus and processing test score from Baseline, measured via computerized cognitive assessment
|
Baseline, Week 2, Week 4, and Week 6
|
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Change in Cognitive Assessment Score (Paired Associates)
기간: Baseline, Week 2, Week 4, and Week 6
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Mean change in Paired Associates memory task score from Baseline, measured via computerized cognitive assessment
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Baseline, Week 2, Week 4, and Week 6
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Change in Cognitive Assessment Score (Digit Span)
기간: Baseline, Week 2, Week 4, and Week 6
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Mean change in Digit Span short-term memory and attention test score from Baseline, measured via computerized cognitive assessment
|
Baseline, Week 2, Week 4, and Week 6
|
|
Change in Cognitive Assessment Score (Spatial Planning)
기간: Baseline, Week 2, Week 4, and Week 6
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Mean change in Spatial Planning executive function test score from Baseline, measured via computerized cognitive assessment
|
Baseline, Week 2, Week 4, and Week 6
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Self-Reported Focus
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived focus from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Attention
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived attention from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Concentration
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived concentration from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Productivity
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived productivity from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Alertness
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived alertness from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Mental Clarity
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived mental clarity from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
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Change in Self-Reported Mood
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived mood from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Mental Fatigue
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived mental fatigue from Baseline, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Change in Self-Reported Motivation
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
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Mean change in perceived motivation from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
|
Change in Self-Reported Organization
기간: Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
Mean change in perceived organization from Baseline, assessed via self-reported questionnaire
|
Baseline, Week 1, Week 2, Week 4, Week 5, and Week 6
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 20807 (기타 식별자: Fred Hutch/University of Washington Cancer Consortium)
- legacy-20807
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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