Goji Berry and Vasomotor Symptoms Pilot Study (GOJI-VMS)
GOJI-VMS Pilot Study: Effects of Two Goji Berry Powder Forms on HDL Function, Vasomotor Symptoms, and Cognitive Performance
The goal of this clinical trial is to compare two forms of goji berry powder-whole goji berry powder and goji juice powder-in peri- and postmenopausal women aged 40-65 years who experience frequent vasomotor symptoms (hot flashes). The study aims to determine which formulation is more promising for a future larger trial by evaluating effects on HDL cholesterol function, vasomotor symptoms, cognitive performance, and participant acceptability.
The main questions it aims to answer are:
Does whole goji berry powder produce a greater improvement in HDL cholesterol efflux capacity (CEC) over 30 days compared with goji juice powder? Are changes in HDL function associated with changes in hot flash burden, cognitive performance, and self-reported cognitive symptoms?
Researchers will compare participants assigned to whole goji berry powder with participants assigned to goji juice powder to evaluate differences in HDL function, vasomotor symptoms, cognitive outcomes, and intervention acceptability.
Participants will:
Consume one mug cake containing their assigned goji powder daily for 30 days. Record hot flash frequency, duration, and severity using a smartphone-based electronic diary.
Attend study visits at baseline, Day 15, and Day 30. Provide fasting blood samples at baseline and Day 30 for assessment of HDL cholesterol efflux capacity and cardiometabolic biomarkers.
Complete computerized cognitive testing (TabCAT) at baseline and Day 30. Complete questionnaires assessing menopause-related quality of life, brain fog, mental alertness, physical activity, and study acceptability.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Menopausal vasomotor symptoms (VMS), commonly experienced as hot flashes, affect a large proportion of women during the menopausal transition and can negatively impact quality of life, sleep, and cognitive function. Emerging evidence suggests that more frequent vasomotor symptoms may also be associated with markers of vascular dysfunction and adverse brain health outcomes. However, few nutritional interventions have been evaluated for their potential effects on vascular health and vasomotor symptoms in this population.
Goji berries (Lycium barbarum) contain bioactive compounds including carotenoids, polysaccharides, and polyphenols that have been associated with antioxidant, anti-inflammatory, and cardiometabolic benefits. Prior studies suggest that goji berry consumption may influence lipid metabolism and vascular function, but the relative efficacy of different commercial goji preparations remains unclear. Two commonly available forms are whole goji berry powder, produced from the entire dried fruit, and goji juice powder, produced from concentrated juice. These preparations differ substantially in composition and may have different physiological effects.
This pilot study is designed to compare these two goji powder formulations and generate preliminary data to inform the design of a larger clinical trial. In addition to evaluating changes in HDL cholesterol efflux capacity (CEC), a measure of HDL function and reverse cholesterol transport, the study will examine participant-reported vasomotor symptoms, cognitive performance, subjective cognitive symptoms, and menopause-related quality of life. The study will also assess the feasibility and acceptability of delivering goji powder in a standardized mug-cake format and the practicality of using electronic symptom tracking for daily monitoring of hot flashes.
Participants will consume a standardized goji-containing mug cake daily for 30 days and complete study assessments before and after the intervention period. Cognitive performance will be evaluated using a tablet-based cognitive assessment battery, while validated questionnaires will assess menopause-related quality of life, subjective cognitive symptoms, mental alertness, and physical activity. Daily electronic diaries will be used to capture the frequency, duration, and severity of vasomotor symptoms throughout the study period.
As a feasibility pilot, the primary purpose of this study is to estimate effect sizes, assess variability of outcome measures, evaluate adherence and participant experience, and identify the most promising goji powder formulation for future investigation. Findings from this study will help guide the development of larger trials evaluating nutritional strategies to support vascular health, cognitive function, and symptom management in midlife women.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Qianyue (Betty) Sun, MS, RD
- 전화번호: 512-905-2364
- 이메일: qbsun@health.ucdavis.edu
연구 연락처 백업
- 이름: Angela M Zivkovic, PhD
- 이메일: amzivkovic@ucdavis.edu
연구 장소
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California
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Davis, California, 미국, 95616
- Ragle Human Nutrition Research Center
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연락하다:
- Qianyue (Betty) Sun, MS, RD
- 전화번호: 512-905-2364
- 이메일: qbsun@health.ucdavis.edu
-
수석 연구원:
- Angela M Zivkovic, PhD
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult women aged 40-65 years
- Peri- or postmenopausal with vasomotor symptoms (hot flashes) occurring ≥4 days/week over the past 2 weeks
- Willing to consume one mug-cake daily for 30 days
- Willing to complete daily VMS symptom tracking on a smartphone
- Hormone therapy (HRT) is allowed if the dose has been stable for ≥8 weeks and hot flashes are still present
Exclusion Criteria:
- Combined intake of >5 servings of eggs or lutein/zeaxanthin-rich vegetables per week
- Current pregnancy or breastfeeding
- Known allergy or intolerance to goji (Lycium barbarum) or to key mug-cake ingredients (e.g., wheat/gluten, dairy, and eggs)
- Current use of warfarin (goji has reported interactions with anticoagulants); other anticoagulants will be reviewed case-by-case
- Uncontrolled thyroid disease or other medical conditions likely to confound VMS assessment
- Initiation or planned change of HRT, GLP-1 agonists, or other medications known to affect lipid metabolism or VMS during the 30-day study
- Current participation in another interventional study
- Any condition that, in the judgment of investigators, makes participation unsafe or data interpretation unreliable
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Goji Berry Juice Powder
In this arm, participants consume goji berry juice powder
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Participants will be instructed to consume 2 tbsp of goji berry juice powder in the form of a mug cake daily for one month
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실험적: Goji Berry Powder
In this arm, participants will consume goji berry powder
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Participants will be instructed to consume 2 tbsp of goji berry powder in the form of a mug cake daily for a month
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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High-Density Lipoprotein (HDL) Cholesterol Efflux Capacity (CEC)
기간: 1 month
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Measure the capacity of isolated HDL to efflux cholesterol out of macrophages
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1 month
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cognitive function
기간: 1 month
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Cognitive function will be assessed using web-based TabCAT tests
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1 month
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Lipoprotein profile
기간: 1 month
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Lipoprotein profiles will be measured using NMR Lipoprofile
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1 month
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Mental Fatigue
기간: 1 month
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Mental fatigue will be measured using the Karolinska Sleepiness Scale
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1 month
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Physical Activity
기간: 1 month
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The physical activity will be measured using IPAQ-Short Form
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1 month
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Average Weekly Vasomotor Symptom Severity Index
기간: 1 month
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The average weekly vasomotor symptoms severity index will be calculated based on intensity, duration, and frequency.
The range of value is 1-3, with 1 being mild and 3 being severe.
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1 month
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Menopause-specific quality of life (MENQOL) scores
기간: 1 month
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The quality of life will be measured using the menopause-specific quality of life (MENQOL) questionnaire.
The questionnaire produces four separate scores: the vasomotor score, ranging from 1 to 8; the psychosocial score, ranging from 1 to 8; the physical score, ranging from 1 to 8; and the sexual score, ranging from 1 to 8. A low score indicates symptoms are absent or not disruptive to well-being, and a high score reflects an intense, persistent symptom profile
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1 month
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Plasma lutein
기간: 1 month
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Plasma concentrations of lutein will be measured by LC-MS
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1 month
|
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Plasma zeaxanthin
기간: 1 month
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Plasma concentrations of zeaxanthin will be measured by LC-MS
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1 month
|
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Total Brain Fog Scale Score
기간: 1 month
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Brain fog will be measured using the Brain Fog Scale.
23 items measured on 5 point likert scale from 1 to 5; the range for the total BFS score is 23-115 points, with a lower score meaning minimum cognitive disruption and a higher score indicating severe brain fog
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1 month
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2318047
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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