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NCT07660315
Goji Berry and Vasomotor Symptoms Pilot Study
Conditions: Vasomotor Symptoms
Sex: Female
Ages: 40 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 6
Sponsor: University of California, Davis
Location: Ragle Human Nutrition Research Center Davis California
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). 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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07660315). StuddyBuddy aggregates publicly available trial information.