| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteopenia, Generalized | Dietary Supplement: Lifenol® Dietary Supplement: Placebo | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women |
| Actual Study Start Date : | August 1, 2019 |
| Actual Primary Completion Date : | December 11, 2020 |
| Actual Study Completion Date : | December 11, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Lifenol
50 participants who meet the eligibility criteria will be randomised under active arm and will receive Lifenol product during 12 months
|
Dietary Supplement: 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 |
|
Placebo Comparator: Placebo
50 participants who meet the eligibility criteria will be randomised under Placebo arm and will receive placebo product during 12 months
|
Dietary Supplement: Placebo
Maltodextrin = 500 mg/capsule + 1000 mg of calcium and 800 IU of vitamin D per day |
| Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Be able to give written
Exclusion Criteria:
| Ireland | |
| Atlantia Food Clinical Trials | |
| Cork, Ireland, T23 R50R | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 10, 2019 | ||||
| First Posted Date ICMJE | July 1, 2019 | ||||
| Last Update Posted Date | January 6, 2021 | ||||
| Actual Study Start Date ICMJE | August 1, 2019 | ||||
| Actual Primary Completion Date | December 11, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
|
||||
| Original Primary Outcome Measures ICMJE |
To evaluate in postmenopausal women with osteopenia, the effect of 12 month Lifenol® treatment on bone mineral density (BMD) at the L2-L4 lumbar spine region. [ Time Frame: 12 months ] Participants will have a bone density DXA scan 7 days before randomisation and 7 days before their last visit 12 months later. These DXA results will provide BMD at L2-L4 lumbar spine region.
|
||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures |
|
||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women | ||||
| Official Title ICMJE | A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women | ||||
| Brief 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 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
||||
| Condition ICMJE | Osteopenia, Generalized | ||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | December 11, 2020 | ||||
| Actual Primary Completion Date | December 11, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Be able to give written Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 50 Years to 85 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Ireland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04004013 | ||||
| Other Study ID Numbers ICMJE | AFCRO-100 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | Naturex SA | ||||
| Study Sponsor ICMJE | Naturex SA | ||||
| Collaborators ICMJE | Atlantia Food Clinical Trials | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Naturex SA | ||||
| Verification Date | January 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||