Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women (NCT04004013) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Effect of Lifenol in Improving Bone Status in Postmenopausal Osteopenic Women
Ireland100 participantsStarted 2019-08-01
Plain-language 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.
Who can participate
Age range50 Years – 85 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be able to give written informed consent;
✓. Be 50 - 85 years of age;
✓. Be a free-living postmenopausal (\> 1 year post menopause) woman;
✓. Have a Body Mass Index (BMI) 18 - 32.0 kg/m²;
✓. Present with a stable weight (+/- 3 kg) for at least the last three (3) months;
✓. Be a non-smoker
✓. Maintain existing food and physical activity patterns throughout the study period;
✓. Present with osteopenia defined as a dual energy X-ray absorptiometry (DXA) T score comprised between -1 and -2.5;
Exclusion criteria
✕. Are hypersensitive to any of the components of the investigational product;
✕. Is currently involved in any other clinical trial or having participated in a trial within the preceding 60 days;
✕. Has a diagnosis of osteoporosis (defined as a T score strictly inferior to -2.5);
✕. Is currently a smoker;
✕. Trying to lose weight for the last three (3) months (following a diet or exercise regimen designed for weight loss);
✕
What they're measuring
1
Bone mineral density at the L2-L4 lumbar spine region
. Recent (within 4 weeks) gastroenteritis or food borne illness;
✕. Having taken antibiotics or laxatives during the preceding 2 months or anticipated consumption;
✕. Currently taking (and during the past 3 months) any drug for osteoporosis (bisphosphonates, parathyroid hormone, strontium ranelate or denosumab);