This study aims to explore the positive effect of a dietary supplement composed of wheat polar lipids on vaginal dryness in healthy postmenopausal women
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
The study foresees the intake of 1 capsule per day during 12 weeks
The study foresees the intake of 1 capsule per day during 12 weeks
Center of Investigation in Clinical Nutrition (CICN)
Louvain-la-Neuve, Belgium, Belgium
RECRUITINGChange 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")
Time frame: 2, 4, 6, 8, 10 and 12 weeks
Change in vaginal pH level
Comparison between groups of the vaginal pH level assessed using a testing strip
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 and 12 weeks
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