An interventional study of Goji Berry Juice Powder and Goji Berry Powder in Vasomotor Symptoms, sponsored by University of California, Davis. Not yet recruiting at 1 site in United States. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of California, Davis · Not applicable, Interventional, and Basic science
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.
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.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's planned enrollment of 6 is below the median of 90 across 306 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this arm, participants consume goji berry juice powder
Other: Goji Berry Juice Powder
In this arm, participants will consume goji berry powder
Other: Goji Berry 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
Participants will be instructed to consume 2 tbsp of goji berry powder in the form of a mug cake daily for a month
High-Density Lipoprotein (HDL) Cholesterol Efflux Capacity (CEC)
Measure the capacity of isolated HDL to efflux cholesterol out of macrophages
Time frame: 1 month
Average Weekly Vasomotor Symptom Severity Index
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.
Time frame: 1 month
Menopause-specific quality of life (MENQOL) scores
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
Time frame: 1 month
Cognitive function
Cognitive function will be assessed using web-based TabCAT tests
Time frame: 1 month
Plasma lutein
Plasma concentrations of lutein will be measured by LC-MS
Time frame: 1 month
Plasma zeaxanthin
Plasma concentrations of zeaxanthin will be measured by LC-MS
Time frame: 1 month
Lipoprotein profile
Lipoprotein profiles will be measured using NMR Lipoprofile
Time frame: 1 month
Mental Fatigue
Mental fatigue will be measured using the Karolinska Sleepiness Scale
Time frame: 1 month
Total Brain Fog Scale Score
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
Time frame: 1 month
Physical Activity
The physical activity will be measured using IPAQ-Short Form
Time frame: 1 month
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
Of 56 non-industry interventional studies with no phase under Hot Flashes, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 8 months is below that.
Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 10 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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