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Goji Berry and Vasomotor Symptoms Pilot Study (GOJI-VMS)

2026年8月15日 更新者:University of California, Davis

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:

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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

6

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • California
      • Davis、California、アメリカ、95616
        • Ragle Human Nutrition Research Center
        • コンタクト:
        • 主任研究者:
          • Angela M Zivkovic, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Goji Berry Juice Powder
In this arm, participants consume goji berry juice 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
実験的:Goji Berry Powder
In this arm, participants will consume goji berry powder
Participants will be instructed to consume 2 tbsp of goji berry powder in the form of a mug cake daily for a month

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
High-Density Lipoprotein (HDL) Cholesterol Efflux Capacity (CEC)
時間枠:1 month
Measure the capacity of isolated HDL to efflux cholesterol out of macrophages
1 month

二次結果の測定

結果測定
メジャーの説明
時間枠
Cognitive function
時間枠:1 month
Cognitive function will be assessed using web-based TabCAT tests
1 month
Lipoprotein profile
時間枠:1 month
Lipoprotein profiles will be measured using NMR Lipoprofile
1 month
Mental Fatigue
時間枠:1 month
Mental fatigue will be measured using the Karolinska Sleepiness Scale
1 month
Physical Activity
時間枠:1 month
The physical activity will be measured using IPAQ-Short Form
1 month
Average Weekly Vasomotor Symptom Severity Index
時間枠:1 month
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.
1 month
Menopause-specific quality of life (MENQOL) scores
時間枠:1 month
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
1 month
Plasma lutein
時間枠:1 month
Plasma concentrations of lutein will be measured by LC-MS
1 month
Plasma zeaxanthin
時間枠:1 month
Plasma concentrations of zeaxanthin will be measured by LC-MS
1 month
Total Brain Fog Scale Score
時間枠:1 month
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
1 month

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月25日

一次修了 (推定)

2027年6月30日

研究の完了 (推定)

2027年10月31日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月11日

最初の投稿 (実際)

2026年6月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月18日

QC基準を満たした最後の更新が送信されました

2026年8月15日

最終確認日

2026年8月1日

詳しくは

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