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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
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
Maltodextrin = 500 mg/capsule \+ 1000 mg of calcium and 800 IU of vitamin D per day
Atlantia Food Clinical Trials
Cork, Ireland
Bone mineral density at the L2-L4 lumbar spine region
Change of bone mineral density at L2-L4 lumbar spine region over 12 months.
Time frame: baseline and 12 months
Bone mineral density at the femoral neck region
DXA scan will provide this parameter
Time frame: baseline, 6 and 12 months
Bone mineral content at the L2-4 lumbar spine and femoral neck region
DXA scan will provide this parameter
Time frame: baseline, 6 and 12 months
T-score
DXA scan will provide this parameter
Time frame: baseline, 6 and 12 months
Fracture risk assessment tool (FRAX) score
FRAX score will be calculated an online tool (university of sheffield frax tool).
Time frame: baseline, 6 and 12 months
Plasma bone biomarkers
Change in plasma bone biomarkers will be measured.
Time frame: baseline, 6 and 12 months
Plasma prenylflavonoids
Change in plasma prenylflavonoids will be measured.
Time frame: baseline, 6 and 12 months
Glucose homeostasis and lipid profile
Change in plasma glucose, insulin and lipids will be measured.
Time frame: baseline, 6 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Quality of life evaluation
36-item short form (SF-36) will be performed to assess by quality of life.
Time frame: 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).
Time frame: baseline, 3, 6, 9 and 12 months