Osteopenia, Sarcopenia
Conditions
Keywords
Vitamin D, bone loss
Brief summary
The present project hypothesizes that the potential protective effect of olive oil relies on its polyphenols profile (quality and quantity) and that it may be synergistic to other food components. Among the nutrients that may be of interest for bone and muscle tissues, unsaturated fatty acids and vitamins are the most described. Consequently, based on the promising available preliminary data, the present project aims to investigate the possible preventive effect of olive oil polyphenols and eventually the synergistic effects of fatty acids and vitamin D on bone, muscle and adipose tissue, in order to prevent any locomotor dysfunction. Volunteers will be supplemented during 9 months. The primary and secondary outcome measures will be performed at baseline, 3 and 9 months.
Interventions
DIETARY_SUPPLEMENTolive oil
Sponsors
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Centre de Recherche en Nutrition Humaine d'Auvergne
Lesieur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
57 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Caucasian female * Within at least 7 years post-menopause * Generally healthy as determined by standard medical assessment on physical and mental health * Normal weight as determined by BMI (20≤ BMI ≤30) * Affiliated to National Health Insurance * Willing to comply with the study procedures * Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data * Having received both oral and written explanations about the study * Having provided her written informed consent
Exclusion criteria
* Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignancy, chronic malnutrition * Osteoporosis (defined by T-score of -2.5 standard deviation (SD) at hip and/or spine) * On therapy with drugs known to interfere with bone and muscle metabolism * Taking regular calcium and vitamin D supplements * Currently participating or having participated in another clinical trial during past 1 year prior to the beginning of this study, this depending on the type of previous study• * Intense Physical activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in bone mineral density | at baseline and after 9 months of supplementation |
Secondary
| Measure | Time frame |
|---|---|
| Changes in serum markers of bone resorption | At baseline, 3 and 9 months |
| changes in serum markers of bone formation | At baseline, 3 and 9 months |
Countries
France
Outcome results
None listed