Condition category
Musculoskeletal Diseases
Date applied
13/11/2017
Date assigned
02/01/2018
Last edited
22/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hip fractures are a major public health problem worldwide, contributing to decrease quality of life and premature death. More than two-thirds of all hip fractures occur in women due to postmenopausal osteoporosis (bone loss that occurs after menopause due to changes in hormone levels). To improve nutrition and lifestyle habits, as well as to increase physical activity are the best weapons to reduce the incidence of osteoporosis (and hip fractures). The aim of this study is to evaluate the beneficial effects of moderate beer intake (regular beer and dealcoholized beer) on bone mineral density (BMD) in postmenopausal women.

Who can participate?
Women aged 45 to 70 years old who are within five years of menopause.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group drink water for two years at dinner. Those in the second group receive dealcoholized beer for two years. Those in the last group receive regular beer (330 mL/day) for two years. In order to know whether beer components (e.g. ethanol, silicon, polyphenols) promote bone formation and/or reduce bone resorption this study will investigate the rates of bone formation and bone loss by measuring their biomarkers in serum and urine at baseline and at six, 12 and 24 months.

What are the possible benefits and risks of participating?
As we explained before, it has been suggested that moderate beer intake may have a protective role in osteoporosis, by increasing bone formation or decreasing bone resorption by several mechanisms. This study will allow to analyse bone mineral density and other mechanisms by which beer or dealcoholised beer may prevent bone loss and increase bone formation, reducing medication and improving live quality. There are no risks to participate in this study as long as the exclusion criteria are followed. The study was conducted according to the Declaration of Helsinki of the World Medical Association.

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 December 2019

Who is funding the study?
CIBER (Consorcio Centro de Investigación Biomédica en Red, M.P) (Spain)

Who is the main contact?
Dr Rosa MaríaLamuela-Raventós (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rosa María Lamuela-Raventós

ORCID ID

http://orcid.org/0000-0002-1287-4560

Contact details

Consorcio Centro de Investigacion Biomedica en Red
M.P. (CIBER)
Instituto de Salud Carlos III
C/Monforte de Lemos 3-5
Pabellon 11
Madrid
28029
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 bone mineral density and molecular bone markers

Acronym

POLYBOST

Study hypothesis

Due to its polyphenol, silicon and ethanol content, moderate beer consumption may participate to prevent osteoporosis in postmenopausal women, providing beneficial effects on bone tissue, stimulating human osteoblasts formation, reducing bone fragility and increasing bone mineral density (BMD).

Ethics approval

Institutional Review Board of the University of Barcelona, 09/03/2017

Study design

A long-term (2 years) 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 below to request a patient information sheet

Condition

Bone Mineral Density (BMD)

Intervention

Participants are randomly assigned following simple randomisation procedures (computerised random numbers) to 1 of 3 intervention groups.

Intervention 1: Control group with water for 2 years (ERB-C).
Intervention 2: 660 mL/day of dealcoholised beer for 2 years (ERB-D).
Intervention 3: 330 mL/day (15 g of ethanol/day) of regular beer for 2 years (ERB-A).

After a run-in period of 30 days, in which subjects are asked not to consume any alcoholic beverage or alcohol-free beer, they receive 15 g of ethanol/day as regular beer, the same amount of nonalcoholic components (polyphenols and silicon) in alcohol-free beer and the same amount of water at dinner during two years in a prospective, randomized, parallel and controlled trial. The follow-up for all interventions is at baseline, six months, 12 months and 24 months. The compliance of interventions are assessed by data from questionnaires and by determination of isoxanthohumol levels in urine, a biomarker of beer intake.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Bone mineral density is measured using the dual energy X-ray absorptiometry (DXA) at baseline, 1 year and at the end of the intervention period
2. Trabecular bone score (TBS) at lumbar spine is measured using the DXA at baseline, 1 year and at the end of the intervention period
3. Volumetric dual-energy X-ray absorptiometry (3D-DXA) at the proximal femur is measured using 3D-DXA at baseline, 1 year and at the end of the intervention period
4. Markers of bone formation (serum PINP and bone AP concentrations) and bone resorption (s-CTX and u-NTX concentrations) are measured by ELISA and electrochemiluminiscence, CrossLaps ELISA and ELISA Ostex, respectively, at baseline, 6 months, 1 year and at the end of the intervention period
5. Molecular mediators of bone turnover, namely sclerostin and Dkk-1 are measured using a newly developed ELISA (Biochemical GMBH) at baseline, 6 months, 1 year and at the end of the intervention period

Secondary outcome measures

1. 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 (personal questionnaire), anthropometric measurements (measured using stand-alone stadiometer and a tape measure), clinical blood pressure (measured using and electronic pressure Omron apparatus) and full blood analysis (glucose, glycated hemoglobin, triglycerids, total cholesterol, HDLc, LDLc, lipoprotein (a), creatinine, calcium, phosphatase, PTH, 25OHD measured using blood samples) and the collection of 24-h urine samples
2. Dietary evaluation: nutrient intake and adherence to dietary recommendations is measured using a 7-day food record validated nutritional questionnaire and a Food Frequency test at baseline, six months, one year and at the end of the interventions
3. Physical activity is measured using the Minnesota Leisure Time Physical Activity questionnaire at baseline, six months, one year and at the end of the intervention period
4. Bioavailability, identification and quantification 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
5. Changes in urine metabolites is 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

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women between 45 and 70 years of age within 5 years of menopause
2. FSH > 3 Miu/mL
3. Estradiol (E2) = 30 pg/mL
4. 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

30/04/2018

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, we have written a review “Impact of Beer Consumption on Human Health” (Nutrients, under review).
After this period, we plan to publish a second and a third publication in a high-impact Journal. “Moderate beer consumption (with and without alcohol) and menopause: health effects of polyphenols and silicon and implications)”, it would be submitted by December 2018, and “Moderate beer consumption (with and without alcohol) and osteoporosis: results from a randomized clinical trial in postmenopausal women”, it would be submitted by December 2019.

IPD sharing statement:
At this moment, our participant level data is not expected to be available, there isn’t enough information. As researchers, we are responsible to share the data generated by our interventional clinical trial. Following the ethical obligation, we could share individual participant data that underlie the results reported in an article as soon as the article would be written to an end date to investigators or researchers who want to provide new proposals. All personal data will be protected.

Intention to publish date

01/12/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/01/2018: The recruitment end date was changed from 31/12/2017 to 30/04/2018.