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

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.

Inclusion Criteria:

1. Be able to give written informed consent;
2. Be 50 - 85 years of age;
3. Be a free-living postmenopausal (> 1 year post menopause) woman;
4. Have a Body Mass Index (BMI) 18 - 32.0 kg/m²;
5. Present with a stable weight (+/- 3 kg) for at least the last three (3) months;
6. Be a non-smoker
7. Maintain existing food and physical activity patterns throughout the study period;
8. Present with osteopenia defined as a dual energy X-ray absorptiometry (DXA) T score comprised between -1 and -2.5;
9. Be willing to consume the investigational product daily for the duration of the study.

Be able to give written

Exclusion Criteria:

1. Are hypersensitive to any of the components of the investigational product;
2. Is currently involved in any other clinical trial or having participated in a trial within the preceding 60 days;
3. Has a diagnosis of osteoporosis (defined as a T score strictly inferior to -2.5);
4. Is currently a smoker;
5. Trying to lose weight for the last three (3) months (following a diet or exercise regimen designed for weight loss);
6. Recent (within 4 weeks) gastroenteritis or food borne illness;
7. Having taken antibiotics or laxatives during the preceding 2 months or anticipated consumption;
8. Currently taking (and during the past 3 months) any drug for osteoporosis (bisphosphonates, parathyroid hormone, strontium ranelate or denosumab);
9. Currently taking (and during the past 3 months) treatment with oestrogen or hormone therapy;
10. Currently taking (and during the past 3 months) treatment with oestrogen agonist or antagonist products (raloxifene or tamoxifene);
11. Currently taking any supplementation with isoflavones or foods fortified with isoflavones;
12. Currently taking (and during the past 4 weeks) any vitamin K supplementation.
13. Exhibiting excess alcohol consumption, defined as greater than 11 standard drinks per week for women or drug dependence,
14. 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;
15. Has a known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease;
16. 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;
17. 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;
18. Has uncontrolled hypothyroidism or hyperthyroidism; subject must be stable on medication for 3 months
19. Current illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation/severe, difficulty swallowing).
20. 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.