Condition category
Not Applicable
Date applied
13/11/2017
Date assigned
23/01/2018
Last edited
23/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measure

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 (if study stopped)

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

http://www.ciberobn.es

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes