Evaluation of moderate daily intake of beer in reducing menopausal symptoms: estrogenic effect of hop prenylflavanoids

Not Applicable

Completed

• Conditions: Menopause; Not Applicable

• Registration Number: ISRCTN14959650
• Lead Sponsor: CIBER (Consorcio Centro de Investigación Biomédica en Red, M.P.)

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34209273/ (added 24/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-23
• Study Completion: 2020-01-30
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

Current inclusion criteria as of 11/05/2021:
Postmenopausal women between 45 and 70 years of age:
1. FSH 23-116 U/L
2. Estradiol (E2) <37 pg/ml
3. Amenorrhea =12 months

Previous inclusion criteria:
Women between 45 and 70 years of age within 5 years of menopause:
1. FSH >3 Miu/ml
2. Estradiol (E2) =30 pg/ml
3. Amenorrhea =12 months

Exclusion Criteria

Current exclusion criteria as of 28/05/2021:
1. Participants using estrogen therapy
2. Participants who received silicon or polyphenol supplements

Previous exclusion criteria:
1. Patients with known diseases affecting bone metabolism (rheumatoid arthritis, hyperthyroidism, surgical menopause, hypercortisolism, renal bone disease, chronic liver disease, among others)
2. Use of drugs affecting bone metabolism (fluorides, bisphosphonates, calcitonin, teriparatide or parathormone, strontium ranelate, SERMs, estrogen therapy, anabolic steroids, chronic glucocorticoids (> 3 months), cytostatics, antiandrogens and antiepileptics)
3. Participants who received silicon or polyphenol supplements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Menopausal symptoms (hot flashes, sweating, palpitations, dizziness, vaginal dryness, mood swings, etc), measured using the Menopause Rating Scale at baseline, 1.5, 3 and 6 months<br> 2. Calcium excretion, measured using liquid chromatography coupled mass spectrometry at baseline and 6 months<br> 3. Menopausal-related hormone profile, measured using ELISA at baseline, 1.5, 3 and 6 months<br>