A Nutritional Supplement on Vasomotor Symptoms in Women
Condition: Menopause
Study type: Interventional

Summary: 
      Vasomotor symptoms (VMS), such as flushes, sweating, and sleep disturbances, are experienced
      by up to 80% of women during the menopausal transition. Night sweats, which are hot flushes
      that occur at night, can be particularly bothersome in women and contribute to disturbed
      sleep. These symptoms occur mainly during the 1-3 years prior to menopause (late
      perimenopause) and early menopause (~4 years after menstruation ceases). Many women look to
      supplements for the management of menopausal symptoms. Soy isoflavones and their metabolites
      are one category of dietary supplements that have been extensively studied for the management
      of VMS. The most active soy isoflavone is S-equol, which is not found directly in soy, but
      rather is the metabolite that is produced by gut microflora from consumption of the soy
      isoflavone daidzein. However, only 20-30% of US women are actually able to produce S-equol
      from the consumption of daidzein. Equelle® is a currently available dietary supplement that
      has S-equol as its active component, which allows the delivery of the active soy isoflavone
      metabolite directly without dependence on the gut microflora metabolism. The intention of
      this study is to assess the effect of a product containing S-equol on the management of VMS
      in normally healthy women.

      Condition or disease: Vasomotor Symptoms

      Intervention/treatment:

      Dietary Supplement: S-equol Dietary Supplement: Placebo
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, parallel study, which will include a
      screening visit (Visit 1; week -3), a 2-week run-in period for baseline determination and
      assessment of placebo response (Visit 2; week -2; and Visit 3; week -1), one baseline visit
      (Visit 4; week 0), and three test visits (Visits 5, 6, and 7; weeks 4, 8, and 12).

      At Visit 1 (week -3), after subjects have provided informed consent, medical history will be
      reviewed, and clinic visit procedures will be performed, including assessments of
      prior/current medication/supplement use, evaluations of inclusion/exclusion criteria, and a
      last menses query. Fasting (10-14 h) blood samples will be collected for assessment of FSH
      and estradiol levels. The Soy Food Frequency Questionnaire will be administered and subjects
      will be instructed to maintain their habitual diets (with the exception of avoiding soy
      foods) and physical activity patterns throughout the study period. Additionally, subjects
      will be dispensed the Insomnia Severity Index Questionnaire (ISIQ) and the VMS Diary to
      assess insomnia and VMS, respectively.

      At Visit 2 (week -2), eligible subjects will be instructed to start the run-in placebo
      product for two weeks. Subjects will be also instructed to continue daily recording in the
      VMS Diary. At Visit 3 (week -1), the VMS Diary will be collected/reviewed to assess response
      to the run-in placebo product. Subjects who continue to meet the inclusion/exclusion criteria
      will be allowed to continue with the study and will be dispensed a sleep tracking device to
      wear for sleep/wake pattern evaluation.

      At Visit 4 (week 0), eligible subjects will be randomized to one of the study products
      (Active or Placebo) and instructed to consume with water for 12 weeks. Additionally, the
      Pittsburg Sleep Quality Index (PSQI), RAND-36 Questionnaire, Profile of Mood States (POMS),
      Day-to-Day Impact of Vaginal Aging Questionnaire (DIVQ), Chalder Fatigue Scale, and
      Menopause-Specific Quality of Life (MENQOL) Questionnaire will be administered. The VMS Diary
      and ISIQ will be collected and reviewed.

      At Visits 5 and 6 (weeks 4 and 8), the VMS Diary and ISIQ will be collected/reviewed, and the
      PSQI and MENQOL will be administered. Subjects will return to the clinic prior to Visit 7
      (week 12) to receive the sleep tracking device to wear for sleep/wake pattern evaluation one
      week (7 d) prior to Visit 7 (week 12).

      At Visit 7 (week 12), the VMS Diary and ISIQ will be collected and reviewed. The PSQI,
      RAND-36, POMS, DIVQ, Chalder Fatigue Scale, and MENQOL will be administered and study product
      will be collected/reviewed, and compliance will be determined. Additionally, the sleep
      tracker will be collected, and data will be downloaded for evaluation.
    

Intervention name(s): Placebo; S-equol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 tablets/d (2 in the morning and 2 in the evening); 4 tablets/d (2 in the morning and 2 in the evening), providing 10 mg S-equol total a day Other Names: •Equelle®
Intervention MeSH terms: Equol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: menopause