Goji Berry and Vasomotor Symptoms Pilot Study

NCT07660315 | Not Yet Recruiting

• 1 other identifier: 2318047
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasomotor Symptoms

Keywords

Goji Berry; Vasomotor Symptoms; Hot flush; Lutein; Zeaxanthin; Carotenoids; HDL; Cholesterol Efflux Capacity

Outcome Measures

Primary Outcomes (1)

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

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

  1 month

Secondary Outcomes (9)

• Average Weekly Vasomotor Symptom Severity Index

  1 month

• Menopause-specific quality of life (MENQOL) scores

  1 month

• Cognitive function

  1 month

• Plasma lutein

  1 month

• Plasma zeaxanthin

  1 month

Study Arms (2)

Goji Berry Juice Powder

ACTIVE COMPARATOR

In this arm, participants consume goji berry juice powder

Other: Goji Berry Juice Powder

Goji Berry Powder

EXPERIMENTAL

In this arm, participants will consume goji berry powder

Other: Goji Berry Powder

Interventions

Goji Berry Juice Powder OTHER

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 Juice Powder

Goji Berry Powder OTHER

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

Goji Berry Powder

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Ragle Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qianyue (Betty) Sun, MS, RD

CONTACT

512-905-2364; qbsun@health.ucdavis.edu

Angela M Zivkovic, PhD

CONTACT

amzivkovic@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)