Olive Oil Polyphenols, Vitamin D, Docosahexaenoic Acid (DHA) and Locomotor Function (PolivD3)

Study Overview
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Brief Summary
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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.

Official Title
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Olive Oil Polyphenols, Vitamin D and Docosahexaenoic Acid (DHA) Synergistic Effects on Locomotor Function

Conditions
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Osteopenia, Sarcopenia

Intervention / Treatment
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* Dietary Supplement: olive oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 57 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extra virgin olive oil<br>Extra virgin olive oil | Dietary Supplement: olive oil<br> <br> |
| Experimental: Enriched extra virgin olive oil<br>Enriched extra virgin olive oil | Dietary Supplement: olive oil<br> <br> |
| Placebo Comparator: refined olive oil<br>refined olive oil | Dietary Supplement: olive oil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone mineral density |  | at baseline and after 9 months of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, bone loss