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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-04-30

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.

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Detailed Description

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Conditions

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Osteopenia Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Extra virgin olive oil

Group Type ACTIVE_COMPARATOR

olive oil

Intervention Type DIETARY_SUPPLEMENT

Enriched extra virgin olive oil

Group Type EXPERIMENTAL

olive oil

Intervention Type DIETARY_SUPPLEMENT

refined olive oil

Group Type PLACEBO_COMPARATOR

olive oil

Intervention Type DIETARY_SUPPLEMENT

Interventions

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olive oil

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

57 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes