Plain English Summary
Background and study aims
The menopause is a natural part of ageing that usually occurs between 45 and 55 years of age as a woman's estrogen levels decline, which triggers the uncomfortable symptoms of hot flushes, night sweats, sleep disturbances, and vaginal dryness. These symptoms can significantly affect the quality of life of menopausal women. Phytoestrogens are compounds naturally found in some vegetables which act like estrogen - the most popular ones are soy and flax-seed phytoestrogens. Hops used in beer brewing are a rich source of phytoestrogens, and moderate daily intake of beer may decrease menopausal symptoms. Therefore, this study aims to find out whether moderate daily intake of beer reduces menopausal discomforts.
Who can participate?
Women aged between 45 and 70 within 5 years of menopause
What does the study involve?
Participants are randomly allocated to one of three groups. The first group drink water, the second group drink beer without alcohol, and the third group drink regular beer every day for 6 months. At the beginning, 6 months, 1 year and at the end of each intervention period a medical assessment is performed which includes the participant’s clinical history, dietary evaluation, body measurements, blood pressure, and the collection of blood and urine samples.
What are the possible benefits and risks of participating?
Daily intake of beer may improve menopausal symptoms. There are no risks of participating in this study.
Where is the study run from?
Hospital Clínic of Barcelona (IDIBAPS) (Spain)
When is the study starting and how long is it expected to run for?
January 2017 to June 2018
Who is funding the study?
European Research Advisory Board (ERAB): The European Foundation for Alcohol Research
Who is the main contact?
Dr Rosa M Lamuela-Raventos
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rosa María Lamuela-Raventós
ORCID ID
http://orcid.org/0000-0002-1287-4560
Contact details
Av. Joan XXIII
27-31
Barcelona
08028
Spain
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRB00003099
Study information
Scientific title
Effects of prenylflavonoids of beer and dealcoholised beer on menopausal symptoms and estrogens
Acronym
POLYBHOR
Study hypothesis
Due to its phytoestrogen content, moderate beer consumption redues menopausal symptoms improves menopausal related hormones.
Ethics approval
Institutional Review Board of the University of Barcelona, 09/03/2017
Study design
Mid-term (6 months) randomised parallel-group controlled open intervention trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Menopause
Intervention
All participants in the study are clinically examined and sign an informed consent to accept their participation in the study. Participants are randomly assigned following simple randomisation procedures (computerised random numbers) to 1 of 3 intervention groups.
Intervention 1: control group with water for 6 months (ERB-C)
Intervention 2: 660 mL/day of dealcoholised beer for 6 months (ERB-D)
Intervention 3: 330 mL/day (15 g of ethanol/day) of regular beer for 6 months (ERB-A)
At the beginning, 6 months, 1 year and at the end of each intervention period a medical assessment will be performed which included: clinical history, dietary evaluation, anthropometric measurements, clinical blood pressure and full blood analysis (glucose, glycated hemoglobin, triglycerides, total cholesterol, HDLc, LDLc, lipoprotein (a), creatinine, calcium, phosphatase, PTH, 25OHD) and the collection of 24-h urine samples.
Intervention type
Other
Phase
Drug names
Primary outcome measures
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
2. Calcium excretion, measured using liquid chromatography coupled mass spectrometry at baseline and 6 months
3. Menopausal-related hormone profile, measured using ELISA at baseline, 1.5, 3 and 6 months
Secondary outcome measures
1. Dietary evaluation: nutrient intake and adherence to the dietary recommendations are measured using a 7-day food record validated nutritional questionnaire and a Food Frequency Test at the baseline, 6 months, 1 year and 2 years
2. Physical activity is measured using the Minnesota Leisure Time Physical Activity questionnaire at baseline, 6 months, 1 year and 2 years
3. Bioavailability, identification and quantification of polyphenols in biological samples is measured using LTQ-Orbitrap Mass Spectrometry and HPLC-MS/MS at baseline and at the end of the intervention period
4. Changes in urine metabolites are measured using mass spectrometry and statistical analysis at baseline and at the end of the intervention period
Overall trial start date
02/01/2017
Overall trial end date
30/06/2018
Reason abandoned
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
60
Participant 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
Recruitment start date
01/04/2017
Recruitment end date
31/12/2017
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Clínic of Barcelona (IDIBAPS)
Villaroel 170
Barcelona
08036
Spain
Sponsor information
Organisation
CIBER (Consorcio Centro de Investigación Biomédica en Red, M.P.)
Sponsor details
C/Monforte de Lemos
3-5. Pabellón 11. Planta 0
Madrid
28029
Spain
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
European Research Advisory Board (ERAB): The European Foundation for Alcohol Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
During the recruitment period, the trialists have written a review about polyphenols and menopausal symptoms, “Beer polyphenols and menopause: effects and mechanisms – A review of current knowledge” (Oxidative Medicine and Cellular Longevity, 2017). After this period, they plan to publish a second publication in a high-impact Journal about “Moderate beer consumption and menopausal symptoms: results from a randomized clinical trial in postmenopausal women”. It would be submitted by June 2018.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rosa M. Lamuela Raventós.
Intention to publish date
01/06/2018
Participant level data
Available on request
Results - basic reporting
Publication summary