Osteopenia, Generalized Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women
| Verified date | January 2021 |
| Source | Naturex SA |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | December 11, 2020 |
| Est. primary completion date | December 11, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 50 Years to 85 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Atlantia Food Clinical Trials | Cork |
| Lead Sponsor | Collaborator |
|---|---|
| Naturex SA | Atlantia Food Clinical Trials |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Bone mineral density at the L2-L4 lumbar spine region | Change of bone mineral density at L2-L4 lumbar spine region over 12 months. | baseline and 12 months | |
| Secondary | Bone mineral density at the femoral neck region | DXA scan will provide this parameter | baseline, 6 and 12 months | |
| Secondary | Bone mineral content at the L2-4 lumbar spine and femoral neck region | DXA scan will provide this parameter | baseline, 6 and 12 months | |
| Secondary | T-score | DXA scan will provide this parameter | baseline, 6 and 12 months | |
| Secondary | Fracture risk assessment tool (FRAX) score | FRAX score will be calculated an online tool (university of sheffield frax tool). | baseline, 6 and 12 months | |
| Secondary | Plasma bone biomarkers | Change in plasma bone biomarkers will be measured. | baseline, 6 and 12 months | |
| Secondary | Plasma prenylflavonoids | Change in plasma prenylflavonoids will be measured. | baseline, 6 and 12 months | |
| Secondary | Glucose homeostasis and lipid profile | Change in plasma glucose, insulin and lipids will be measured. | baseline, 6 and 12 months | |
| Secondary | Quality of life evaluation | 36-item short form (SF-36) will be performed to assess by quality of life. | baseline, 3, 6, 9 and 12 months | |
| Secondary | Gastrointestinal tolerance evaluation | Gastrointestinal tolerance of the product will be assessed by the Gastrointestinal Symptom Rating Scale (GSRS). | baseline, 3, 6, 9 and 12 months |