Evaluation of moderate daily intake of beer in reducing menopausal symptoms: estrogenic effect of hop prenylflavanoids
| ISRCTN | ISRCTN14959650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14959650 |
| Secondary identifying numbers | IRB00003099 |
- Submission date
- 13/11/2017
- Registration date
- 23/01/2018
- Last edited
- 24/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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?
Postmenopausal women aged between 45 and 70
What does the study involve?
Participants are assigned to one of the three study groups according to their preference due to the complexity of the mid-term alcohol intake of the intervention. 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 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 January 2020
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
Contact information
Scientific
Av. Joan XXIII, 27-31
Barcelona
08028
Spain
 ORCID ID |
0000-0002-1287-4560 |
|---|
Study information
| Study design | Mid-term (6 months) non-randomized parallel-group controlled open intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effects of prenylflavonoids of beer and dealcoholised beer on menopausal symptoms and estrogens |
| Study acronym | POLYBHOR |
| Study objectives | Current study hypothesis as of 11/05/2021: Due to its phytoestrogen content, moderate beer consumption reduces menopausal symptoms and changes menopausal-related hormonal profile. Previous study hypothesis: Due to its phytoestrogen content, moderate beer consumption reduces menopausal symptoms and improves menopausal-related hormones. |
| Ethics approval(s) | Institutional Review Board of the University of Barcelona, 09/03/2017 |
| Health condition(s) or problem(s) studied | Menopause |
| Intervention | Current interventions as of 11/05/2021: All participants in the study are clinically examined and sign an informed consent to accept their participation in the study. Participants were assigned to one of the three study groups according to their preference due to the complexity of the mid-term alcohol intake of the intervention. 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 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. Previous interventions: 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 |
| 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 | Current secondary outcome measures as of 11/05/2021: 1. Dietary evaluation: nutrient intake and adherence to the dietary recommendations measured using a 7-day food record validated nutritional questionnaire at the baseline and at 6 months. In addition, the food frequency questionnaire and 14-point Mediterranean Diet Adherence questionnaire are recorded at baseline. 2. Physical activity is measured using the Minnesota Leisure Time Physical Activity questionnaire at baseline and 6 months 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 Previous 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 study start date | 02/01/2017 |
| Completion date | 30/01/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Total final enrolment | 37 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 30/06/2019 |
Locations
Countries of recruitment
- Spain
Study participating centre
Barcelona
08036
Spain
Sponsor information
Research organisation
C/Monforte de Lemos, 3-5. Pabellón 11. Planta 0
Madrid
28029
Spain
| Website | http://www.ciberobn.es |
|---|---|
"ROR" |
https://ror.org/00dwgct76 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan, as of 14/12/2021: 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 have published a second publication titled "Moderate consumption of beer (with and without ethanol) and menopausal symptoms: results from a parallel clinical trial in postmenopausal women" (Nutrients, 2021) https://doi.org/10.3390/nu13072278 Previous publication and dissemination plan as of 11/05/2021: 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 daily beer (with and without ethanol) consumption and menopausal symptoms: results from a parallel clinical trial in postmenopausal women". It would be submitted by June 2021. Previous 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rosa M. Lamuela Raventós. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/06/2021 | 24/02/2023 | Yes | No |
Editorial Notes
24/02/2023: Publication reference added.
14/12/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The publication and dissemination plan, was updated.
28/05/2021: The exclusion criteria were updated.
11/05/2021: The following changes were made to the trial record:
1. The study hypothesis, interventions, secondary outcome measures, inclusion criteria, plain English summary and publication and dissemination plan were updated.
2. The study design was changed from 'Mid-term (6 months) randomised parallel-group controlled open intervention trial' to 'Mid-term (6 months) non-randomized parallel-group controlled open intervention trial'.
3. The recruitment end date was changed from 31/12/2017 to 30/06/2019.
4. The overall trial end date was changed from 30/06/2018 to 30/01/2020.
5. The intention to publish date was changed from 01/06/2018 to 01/06/2021.
6. The total final enrolment number was added.
