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

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

Study Overview

• Status: Recruiting
• Conditions: Vaginal Dryness; Menopause Symptoms
• Intervention / Treatment: Dietary supplement: Wheat Polar Lipid Complex; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie Dormal, PhD; Phone Number: +32(0)10 47 93 05; Email: valerie.dormal@uclouvain.be
• Study Contact Backup: Name: Louise Deldicque, Pr; Phone Number: +32(0)10 47 44 43; Email: louise.deldicque@uclouvain.be

Study Locations

• Belgium
  • Belgium
    • Louvain-la-Neuve, Belgium, Belgium, 1348
      • Recruiting
      • Center of Investigation in Clinical Nutrition (CICN)
      • Contact: Valérie Dormal, PhD; Phone Number: +32(0)10 47 93 05; Email: valerie.dormal@uclouvain.be
      • Contact: Louise Deldicque, Pr; Phone Number: +32(0)10 47 44 43; Email: louise.deldicque@uclouvain.be
      • Principal Investigator: Sylvie Copine, Dr
      • Principal Investigator: Laurent Simar, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Dietary supplement - Placebo	Dietary supplement: Placebo; The study foresees the intake of 1 capsule per day during 12 weeks
Experimental: WPLC; Dietary supplement - Wheat Polar Lipid Complex	Dietary supplement: Wheat Polar Lipid Complex; The study foresees the intake of 1 capsule per day during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vaginal dryness intensity	Comparison between groups of the vaginal dryness intensity assessed by a Visual Analogue Scale ranging from 0 ("no dryness at all") to 10 ("extreme vaginal dryness")	2, 4, 6, 8, 10 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vaginal pH level	Comparison between groups of the vaginal pH level assessed using a testing strip	6 and 12 weeks
Change in menopausal symptoms severity	Comparison between groups of the menopausal symptoms severity assessed by the Menopause Rating Scale (MRS) questionnaire	6 and 12 weeks
Change in menopause-specific quality of life	Comparison between groups of menopause-specific quality of life assessed by the Menopause-Specific Quality of Life (MENQOL) questionnaire	6 and 12 weeks
Change in functional and emotional impact of vulvovaginal symptoms	Comparison between groups of functional and emotional impact of vulvovaginal symptoms assessed by the Day-to-day Impact of Vaginal Aging (DIVA) questionnaire	6 and 12 weeks
Evolution of self-perceived improvement of vaginal dryness and menopausal symptoms	Comparison between groups of the adjusted for baseline of self-perceived improvement of vaginal dryness and menopausal symptoms assessed by a visual analogue scale, ranging from 0 = not at all to 4 = very much	6 and 12 weeks

Collaborators and Investigators

• Sponsor: Seppic
• Investigators: Principal Investigator: Sylvie Copine, Dr, Université Catholique de Louvain; Study Director: Louise Deldicque, Pr, Université Catholique de Louvain; Principal Investigator: Laurent Simar, Dr, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Menopause; Vaginal dryness; Wheat polar lipids
• Other Study ID Numbers: MenoWPLC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No