None listed
Conditions
Brief summary
The aim of the study is to assess the effects of a hydrolyzed collagen on bone mineral density assessed by Dual-enegy X-ray absorptiometry (DXA) and bone metabolism in healthy postmenopausal women with osteopenia. This study is designed as a monocentric randomized, double-blind, placebo-controlled clinical trial with 2 parallel groups. There is a screening visit (V0) followed by a randomization visit (V1) which takes place four to ten weeks after V0. The experimental phase with placebo or verum product then lasts 12 months. One intermediate follow-up visit (V2) is planned after 6 months of consumption and the end of study visit is performed after 12 months of consumption (V3). 144 healthy postmenopausal women with osteopenia will be recruited for this study, according to the following inclusion and exclusion criteria.
Interventions
After randomization, the volunteer will take one sachet of hydrolyzed collagen or placebo daily at dinner, during a period of 12 months (from visit V1 to visit V3).
The 10 mg sachet can be dissolved in a cold or warm drink or mixed into a food such as a yoghurt.
Product compliance will be evaluated at V2 and V3 in order to check that all included subjects respect the study protocol with respect to the consumption of the study product. To evaluate the compliance, subjects will be asked to brin
After randomization, the volunteer will take one sachet of hydrolyzed collagen or placebo daily at dinner, during a period of 12 months (from visit V1 to visit V3). The 10 mg sachet can be dissolved in a cold or warm drink or mixed into a food such as a yoghurt. Product compliance will be evaluated at V2 and V3 in order to check that all included subjects respect the study protocol with respect to the consumption of the study product. To evaluate the compliance, subjects will be asked to bring the non-consumed product sachets at V2 and V3.
Sponsors
ROUSSELOT SAS
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
- caucasian female - natural surgical menopause or hormone replacement therapy stop ranging 1 and 5 years - low bone mineral density : T score greater than or equal to -2.5 at the lumbar spine (L1-L4); - low bone mineral density : T score less than or equal to -1 at the lumbar spine (L1-L4); - good general and mental health according to the investigator
Exclusion criteria
- T-score < -2.5 on hip total or femoral neck or great trochanter - Medications: oral steroidal anti-inflammatory, anti-osteoporotic treatment, hormone replacement therapy or other medications incompatible with the study according to the investigator (wash-out period above 6 months except for hormone replacement therapy: 1 year); - Presence of arthrosis that affects the ability to interpret the osteodensitometry - E4. Known Paget's disease, Cushing's disease, hyperparathyroidism, thyroid disease, sarcoidosis, chronic inflammatory bowel disease or chronic inflammatory diseases (rheumatoid arthritis, inflammatory bowel disease), renal lithiasis or any other disease that affects bone metabolism according to the investigator - Personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator - One or more low trauma fractures after age 45 - Known non traumatic vertebral fracture - With significant change in food habits or in physical activity in the 3 months before randomization or not agreeing to keep them unchanged throughout the study - Heavy smoking (> 20 cig. / d); or planning to change his smoking habits throughout the study - Excessive alcohol drinking (> 21 drinks / week); or planning to change his alcohol consumption throughout the study
Outcome results
None listed