NCT04004013

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Givaudan France Naturals · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteopenia, Generalized

Interventions

Type	Name	Description
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
DIETARY_SUPPLEMENT	Placebo	Maltodextrin = 500 mg/capsule \+ 1000 mg of calcium and 800 IU of vitamin D per day

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2019-07-01
• Last updated: 2021-01-06

Locations

1 site across 1 country: Ireland