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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Qianyue (Betty) Sun, MS, RD
- Numéro de téléphone: 512-905-2364
- E-mail: qbsun@health.ucdavis.edu
Sauvegarde des contacts de l'étude
- Nom: Angela M Zivkovic, PhD
- E-mail: amzivkovic@ucdavis.edu
Lieux d'étude
-
-
California
-
Davis, California, États-Unis, 95616
- Ragle Human Nutrition Research Center
-
Contact:
- Qianyue (Betty) Sun, MS, RD
- Numéro de téléphone: 512-905-2364
- E-mail: qbsun@health.ucdavis.edu
-
Chercheur principal:
- Angela M Zivkovic, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Goji Berry Juice Powder
In this arm, participants consume goji berry juice powder
|
Participants will be instructed to consume 2 tbsp of goji berry juice powder in the form of a mug cake daily for one month
|
|
Expérimental: Goji Berry Powder
In this arm, participants will consume goji berry powder
|
Participants will be instructed to consume 2 tbsp of goji berry powder in the form of a mug cake daily for a month
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
High-Density Lipoprotein (HDL) Cholesterol Efflux Capacity (CEC)
Délai: 1 month
|
Measure the capacity of isolated HDL to efflux cholesterol out of macrophages
|
1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive function
Délai: 1 month
|
Cognitive function will be assessed using web-based TabCAT tests
|
1 month
|
|
Lipoprotein profile
Délai: 1 month
|
Lipoprotein profiles will be measured using NMR Lipoprofile
|
1 month
|
|
Mental Fatigue
Délai: 1 month
|
Mental fatigue will be measured using the Karolinska Sleepiness Scale
|
1 month
|
|
Physical Activity
Délai: 1 month
|
The physical activity will be measured using IPAQ-Short Form
|
1 month
|
|
Average Weekly Vasomotor Symptom Severity Index
Délai: 1 month
|
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.
|
1 month
|
|
Menopause-specific quality of life (MENQOL) scores
Délai: 1 month
|
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
|
1 month
|
|
Plasma lutein
Délai: 1 month
|
Plasma concentrations of lutein will be measured by LC-MS
|
1 month
|
|
Plasma zeaxanthin
Délai: 1 month
|
Plasma concentrations of zeaxanthin will be measured by LC-MS
|
1 month
|
|
Total Brain Fog Scale Score
Délai: 1 month
|
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
|
1 month
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2318047
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .