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

Overview

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

Detailed description

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Belgium · 1 center

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

Identifiers

NCT: NCT07386249 · MenoWPLC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗