Osteopenia, GeneralizedNCT04004013
Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women
A study testing Lifenol® in people with Osteopenia, Generalized, run by Givaudan France Naturals at 1 site in Ireland.
Trial summary
A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol® in Improving Bone Status in Postmenopausal Osteopenic Women. 100 postmenopausal women will be enrolled to investigate the effect of a 12 month supplementation with Lifenol® on bone density DXA parameters and plasma bone… Read more about this study
- Who is it for?
- Ages 50 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Generalized
- What is being tested?
- Lifenol®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 1 Aug 2019to 11 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to give written informed consent;
- Be 50 - 85 years of age;
- Be a free-living postmenopausal (> 1 year post menopause) woman;
- Have a Body Mass Index (BMI) 18 - 32.0 kg/m²;
- Present with a stable weight (+/- 3 kg) for at least the last three (3) months;
- Be a non-smoker
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- Maintain existing food and physical activity patterns throughout the study period;
- Present with osteopenia defined as a dual energy X-ray absorptiometry (DXA) T score comprised between -1 and -2.5;
- Be willing to consume the investigational product daily for the duration of the study.
- Be able to give written
Who cannot join
- Are hypersensitive to any of the components of the investigational product;
- Is currently involved in any other clinical trial or having participated in a trial within the preceding 60 days;
- Has a diagnosis of osteoporosis (defined as a T score strictly inferior to -2.5);
- Is currently a smoker;
- Trying to lose weight for the last three (3) months (following a diet or exercise regimen designed for weight loss);
- Recent (within 4 weeks) gastroenteritis or food borne illness;
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- Having taken antibiotics or laxatives during the preceding 2 months or anticipated consumption;
- Currently taking (and during the past 3 months) any drug for osteoporosis (bisphosphonates, parathyroid hormone, strontium ranelate or denosumab);
- Currently taking (and during the past 3 months) treatment with oestrogen or hormone therapy;
- Currently taking (and during the past 3 months) treatment with oestrogen agonist or antagonist products (raloxifene or tamoxifene);
- Currently taking any supplementation with isoflavones or foods fortified with isoflavones;
- Currently taking (and during the past 4 weeks) any vitamin K supplementation.
- Exhibiting excess alcohol consumption, defined as greater than 11 standard drinks per week for women or drug dependence,
- Has a significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives;
- Has a known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease;
- Has a history of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, or carcinoma in situ with no significant progression over the past 2 years;
- Has uncontrolled hypertension (systolic or diastolic blood pressure superior to 160 and 110 respectively). Subject on hypertension medication, must be on stable medication for 3 months;
- Has uncontrolled hypothyroidism or hyperthyroidism; subject must be stable on medication for 3 months
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation/severe, difficulty swallowing).
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women
A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol® in Improving Bone Status in Postmenopausal Osteopenic Women. 100 postmenopausal women will be enrolled to investigate the effect of a 12 month supplementation with Lifenol® on bone density DXA parameters and plasma bone biomarkers.
Read the detailed description
Osteoporosis is a skeletal disorder characterized by reduced bone mass and deterioration in bone architecture leading to an increased bone fragility and fracture risk. Postmenopausal women are a particularly at-risk population as the maintenance of bone homeostasis is influenced by estrogens. Recently, phytoestrogens have drawn attention as an interesting natural way to prevent oestrogen-deficient osteoporosis. Hops contain one of the most potent phytoestrogen known to date: 8-prenylnaringenin (8-PN). Lifenol® is a polyphenolic powdered extract obtained by a patented process from the female hop flowers (Humulus lupulus L.), standardized in 8-PN content.
Therefore, the present clinical trial aims to determine whether long-term consumption of Lifenol® can reduce bone mineral density loss in postmenopausal women with osteopenia taking traditional recommended calcium and vitamin D supplementation (1000 mg of calcium and 800 IU of vitamin D per day).
100 postmenopausal women (>1 year post-menopause) will be enrolled to consume during 12 months either Lifenol® (dose of 100µg of 8-PN per day) or a placebo. Effect of investigational product will be measured notably on bone density DXA parameters and plasma bone biomarkers.
- Conditions
- Osteopenia, Generalized
- Being tested
- Lifenol®, Placebo
- Keywords
- osteopenia, phytoestrogen, hop, menopause
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifenol®Dietary supplement
Lifenol®, powdered extract obtained from female hops flowers (Humulus lupulus L.) standardized in 8-PN content (100 µg /day) + maltodextrin = 500 mg/capsule
+ 1000 mg of calcium and 800 IU of vitamin D per day
PlaceboDietary supplement
Maltodextrin = 500 mg/capsule
+ 1000 mg of calcium and 800 IU of vitamin D per day
| Study group | Role | What they receive |
|---|---|---|
| Lifenol | Active comparator | 50 participants who meet the eligibility criteria will be randomised under active arm and will receive Lifenol product during 12 months Receives: Dietary Supplement: Lifenol® |
| Placebo | Placebo comparator | 50 participants who meet the eligibility criteria will be randomised under Placebo arm and will receive placebo product during 12 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density at the L2-L4 lumbar spine region
Change of bone mineral density at L2-L4 lumbar spine region over 12 months.
Measured: baseline and 12 months
Secondary outcomes (9)
Bone mineral density at the femoral neck region
DXA scan will provide this parameter
Measured: baseline, 6 and 12 months
Bone mineral content at the L2-4 lumbar spine and femoral neck region
DXA scan will provide this parameter
Measured: baseline, 6 and 12 months
T-score
DXA scan will provide this parameter
Measured: baseline, 6 and 12 months
Fracture risk assessment tool (FRAX) score
FRAX score will be calculated an online tool (university of sheffield frax tool).
Measured: baseline, 6 and 12 months
Plasma bone biomarkers
Change in plasma bone biomarkers will be measured.
Measured: baseline, 6 and 12 months
Plasma prenylflavonoids
Change in plasma prenylflavonoids will be measured.
Measured: baseline, 6 and 12 months
Glucose homeostasis and lipid profile
Change in plasma glucose, insulin and lipids will be measured.
Measured: baseline, 6 and 12 months
Quality of life evaluation
36-item short form (SF-36) will be performed to assess by quality of life.
Measured: baseline, 3, 6, 9 and 12 months
Gastrointestinal tolerance evaluation
Gastrointestinal tolerance of the product will be assessed by the Gastrointestinal Symptom Rating Scale (GSRS).
Measured: baseline, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Aug 2019
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004013
- Sponsor's protocol ID
- AFCRO-100
- Status last verified
- Jan 2021
- First submitted
- 10 Jun 2019
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To revisit this after investigation period
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women
- ClinicalTrials.gov ID
- NCT04004013
- Acronym / sponsor ID
- AFCRO-100
- Conditions
- Osteopenia, Generalized
- Keywords
- osteopenia, phytoestrogen, hop, menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Givaudan France NaturalsIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol® in Improving Bone Status in Postmenopausal Osteopenic Women. 100 postmenopausal women will be enrolled to investigate the effect of a 12 month supplementation with Lifenol® on bone density DXA parameters and plasma bone biomarkers.
Detailed description
Osteoporosis is a skeletal disorder characterized by reduced bone mass and deterioration in bone architecture leading to an increased bone fragility and fracture risk. Postmenopausal women are a particularly at-risk population as the maintenance of bone homeostasis is influenced by estrogens. Recently, phytoestrogens have drawn attention as an interesting natural way to prevent oestrogen-deficient osteoporosis. Hops contain one of the most potent phytoestrogen known to date: 8-prenylnaringenin (8-PN). Lifenol® is a polyphenolic powdered extract obtained by a patented process from the female hop flowers (Humulus lupulus L.), standardized in 8-PN content.
Therefore, the present clinical trial aims to determine whether long-term consumption of Lifenol® can reduce bone mineral density loss in postmenopausal women with osteopenia taking traditional recommended calcium and vitamin D supplementation (1000 mg of calcium and 800 IU of vitamin D per day).
100 postmenopausal women (>1 year post-menopause) will be enrolled to consume during 12 months either Lifenol® (dose of 100µg of 8-PN per day) or a placebo. Effect of investigational product will be measured notably on bone density DXA parameters and plasma bone biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifenol | Active comparator | Dietary Supplement: Lifenol®50 participants who meet the eligibility criteria will be randomised under active arm and will receive Lifenol product during 12 months |
| Placebo | Placebo comparator | Dietary Supplement: Placebo50 participants who meet the eligibility criteria will be randomised under Placebo arm and will receive placebo product during 12 months |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be able to give written informed consent;
- Be 50 - 85 years of age;
- Be a free-living postmenopausal (> 1 year post menopause) woman;
- Have a Body Mass Index (BMI) 18 - 32.0 kg/m²;
- Present with a stable weight (+/- 3 kg) for at least the last three (3) months;
Key exclusion criteria (20 listed)
- Are hypersensitive to any of the components of the investigational product;
- Is currently involved in any other clinical trial or having participated in a trial within the preceding 60 days;
- Has a diagnosis of osteoporosis (defined as a T score strictly inferior to -2.5);
- Is currently a smoker;
- Trying to lose weight for the last three (3) months (following a diet or exercise regimen designed for weight loss);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifenol®Lifenol®, powdered extract obtained from female hops flowers (Humulus lupulus L.) standardized in 8-PN content (100 µg /day) + maltodextrin = 500 mg/capsule + 1000 mg of calcium and 800 IU of vitamin D per day | Dietary supplement | Lifenol |
| PlaceboMaltodextrin = 500 mg/capsule + 1000 mg of calcium and 800 IU of vitamin D per day | Dietary supplement | Placebo |
Primary outcome
Bone mineral density at the L2-L4 lumbar spine region
Time frame: baseline and 12 months
Change of bone mineral density at L2-L4 lumbar spine region over 12 months.
9 secondary outcomes
Bone mineral density at the femoral neck region
Time frame: baseline, 6 and 12 months
Bone mineral content at the L2-4 lumbar spine and femoral neck region
Time frame: baseline, 6 and 12 months
T-score
Time frame: baseline, 6 and 12 months
Fracture risk assessment tool (FRAX) score
Time frame: baseline, 6 and 12 months
Plasma bone biomarkers
Time frame: baseline, 6 and 12 months
Plasma prenylflavonoids
Time frame: baseline, 6 and 12 months
Glucose homeostasis and lipid profile
Time frame: baseline, 6 and 12 months
Quality of life evaluation
Time frame: baseline, 3, 6, 9 and 12 months
Gastrointestinal tolerance evaluation
Time frame: baseline, 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: Undecided. To revisit this after investigation period
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifenol® in people with Osteopenia, Generalized, run by Givaudan France Naturals at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density at the L2-L4 lumbar spine region (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.