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
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