Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women

This is an interventional prevention trial for Osteopenia, Generalized focused on measuring osteopenia, phytoestrogen, hop, menopause Read More

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.