Health TrialsbyHealthPanel

Goji Berry and Vasomotor Symptoms Pilot Study

ConditionVasomotor Symptoms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorUniversity of California, Davis

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Goji Berry Juice Powder

    Other intervention

    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 Powder

    Other intervention

    Participants will be instructed to consume 2 tbsp of goji berry powder in the form of a mug cake daily for a month

Treatment groups

6 Participants
are divided into 2 treatment groups
Group A: Goji Berry Juice PowderActive comparator 1 intervention
Group B: Goji Berry PowderExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

High-Density Lipoprotein (HDL) Cholesterol Efflux Capacity (CEC)

Measure the capacity of isolated HDL to efflux cholesterol out of macrophages

Time frame
1 month

Secondary outcomes

1

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
2

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
3

Cognitive function

Cognitive function will be assessed using web-based TabCAT tests

Time frame
1 month
4

Plasma lutein

Plasma concentrations of lutein will be measured by LC-MS

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: