Vasomotor SymptomsGOJI-VMSNCT07660315
Goji Berry and Vasomotor Symptoms Pilot Study
A study testing Goji Berry Juice Powder and Goji Berry Powder in people with Vasomotor Symptoms, run by University of California, Davis at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- Goji Berry Juice Powder and Goji Berry Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Angela M Zivkovic, PhD contact
United States1 site
Ragle Human Nutrition Research Center
Davis, California, 95616
Qianyue (Betty) Sun, MS, RD, 512-905-2364, qbsun@health.ucdavis.edu
Angela M Zivkovic, PhD
About this study
Official title: 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:
Read more
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.
Read the detailed description
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.
- Conditions
- Vasomotor Symptoms
- Being tested
- Goji Berry Juice Powder, Goji Berry Powder
- Keywords
- Goji Berry, Vasomotor Symptoms, Hot flush, Lutein, Zeaxanthin, Carotenoids, HDL, Cholesterol Efflux Capacity
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goji Berry Juice PowderOther
Participants will be instructed to consume 2 tbsp of goji berry juice powder in the form of a mug cake daily for one month
Goji Berry PowderOther
Participants will be instructed to consume 2 tbsp of goji berry powder in the form of a mug cake daily for a month
| Study group | Role | What they receive |
|---|---|---|
| Goji Berry Juice Powder | Active comparator | In this arm, participants consume goji berry juice powder Receives: Other: Goji Berry Juice Powder |
| Goji Berry Powder | Experimental | In this arm, participants will consume goji berry powder Receives: Other: Goji Berry Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-Density Lipoprotein (HDL) Cholesterol Efflux Capacity (CEC)
Measure the capacity of isolated HDL to efflux cholesterol out of macrophages
Measured: 1 month
Secondary outcomes (9)
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.
Measured: 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
Measured: 1 month
Cognitive function
Cognitive function will be assessed using web-based TabCAT tests
Measured: 1 month
Plasma lutein
Plasma concentrations of lutein will be measured by LC-MS
Measured: 1 month
Plasma zeaxanthin
Plasma concentrations of zeaxanthin will be measured by LC-MS
Measured: 1 month
Lipoprotein profile
Lipoprotein profiles will be measured using NMR Lipoprofile
Measured: 1 month
Mental Fatigue
Mental fatigue will be measured using the Karolinska Sleepiness Scale
Measured: 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
Measured: 1 month
Physical Activity
The physical activity will be measured using IPAQ-Short Form
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start25 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660315
- Sponsor's protocol ID
- 2318047
- Acronym
- GOJI-VMS
- Status last verified
- Aug 2026
- First submitted
- 11 Jun 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GOJI-VMS Pilot Study: Effects of Two Goji Berry Powder Forms on HDL Function, Vasomotor Symptoms, and Cognitive Performance
- ClinicalTrials.gov ID
- NCT07660315
- Acronym / sponsor ID
- GOJI-VMS / 2318047
- Conditions
- Vasomotor Symptoms
- Keywords
- Goji Berry, Vasomotor Symptoms, Hot flush, Lutein, Zeaxanthin, Carotenoids, HDL, Cholesterol Efflux Capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goji Berry Juice Powder | Active comparator | Other: Goji Berry Juice PowderIn this arm, participants consume goji berry juice powder |
| Goji Berry Powder | Experimental | Other: Goji Berry PowderIn this arm, participants will consume goji berry powder |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goji Berry Juice PowderParticipants will be instructed to consume 2 tbsp of goji berry juice powder in the form of a mug cake daily for one month | Other | Goji Berry Juice Powder |
| Goji Berry PowderParticipants will be instructed to consume 2 tbsp of goji berry powder in the form of a mug cake daily for a month | Other | Goji Berry Powder |
Primary outcome
High-Density Lipoprotein (HDL) Cholesterol Efflux Capacity (CEC)
Time frame: 1 month
Measure the capacity of isolated HDL to efflux cholesterol out of macrophages
9 secondary outcomes
Average Weekly Vasomotor Symptom Severity Index
Time frame: 1 month
Menopause-specific quality of life (MENQOL) scores
Time frame: 1 month
Cognitive function
Time frame: 1 month
Plasma lutein
Time frame: 1 month
Plasma zeaxanthin
Time frame: 1 month
Lipoprotein profile
Time frame: 1 month
Mental Fatigue
Time frame: 1 month
Total Brain Fog Scale Score
Time frame: 1 month
Physical Activity
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela M Zivkovic, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goji Berry Juice Powder and Goji Berry Powder in people with Vasomotor Symptoms, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qianyue (Betty) Sun, MS, RD (512-905-2364, qbsun@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-Density Lipoprotein (HDL) Cholesterol Efflux Capacity (CEC) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.