Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women

Обзор

This study aims to explore the positive effect of a dietary supplement composed of wheat polar lipids on vaginal dryness in healthy postmenopausal women

Подробное описание

This study is designed as a randomized double-blind placebo-controlled interventional study. One hundred and ten postmenopausal women, aged between 45 and 65 and experiencing vaginal dryness, will be randomly allocated to the control (placebo supplement) or test (active supplement) group. Participants will be supplemented during 12 weeks with those products. Vaginal dryness intensity and menopause symptoms severity will be measured with tests and questionnaires before (baseline), at the middle (6 weeks), and at the end (12 weeks) of the intervention.

Вмешательства

• Пищевая добавка Wheat Polar Lipid Complex
  The study foresees the intake of 1 capsule per day during 12 weeks
• Пищевая добавка Placebo
  The study foresees the intake of 1 capsule per day during 12 weeks

Первичные конечные точки

• Change in vaginal dryness intensity [Срок оценки: 2, 4, 6, 8, 10 and 12 weeks]

Вторичные конечные точки (5)

• Change in vaginal pH level [Срок оценки: 6 and 12 weeks]
• Change in menopausal symptoms severity [Срок оценки: 6 and 12 weeks]
• Change in menopause-specific quality of life [Срок оценки: 6 and 12 weeks]
• Change in functional and emotional impact of vulvovaginal symptoms [Срок оценки: 6 and 12 weeks]
• Evolution of self-perceived improvement of vaginal dryness and menopausal symptoms [Срок оценки: 6 and 12 weeks]

Критерии участия

Критерии включения

• Healthy woman, aged of 45 to 65 years (inclusive)
• In postmenopause, defined according to the STRAW criteria as the absence of menstrual periods for at least 12 consecutive months
• Reporting a vaginal dryness intensity score ≥ 4 on a 0-10 Visual Analogue Scale (VAS), and a score ≥ 16 on the Menopause Rating Scale (MRS)
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Stated willingness to maintain their usual life habits (diet, physical activity, alcohol consumption…)
• Speaking French.

Критерии исключения

• Use of systemic hormonal therapy within the past 3 months
• Use of dietary supplements, herbal products, or over-the-counter remedies intended to alleviate menopausal symptoms within 4 weeks prior to the screening visit (wash-out period ≥ 1 month required)
• Use of vaginal hormonal formulations within 4 weeks prior to screening
• History of hormone-dependent cancers
• History of hysterectomy or bilateral oophorectomy
• Current alcohol dependence or excessive alcohol consumption exceeding an average of 14 standard drinks per week
• Current use of illicit drugs or recent history of drug dependence
• Current or previously diagnosed eating disorders considered likely to impact participant safety or study outcomes
• Presence of severe or uncontrolled chronic medical conditions, or any acute medical condition judged by the investigator to potentially interfere with the MRS assessment or participant safety
• Subject participating in another intervention trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Center of Investigation in Clinical Nutrition (CICN) — Louvain-la-Neuve

Идентификаторы

NCT: NCT07386249 · MenoWPLC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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