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

Not Applicable

Completed

• Conditions: Osteopenia; Sarcopenia
• Interventions: Dietary Supplement: olive oil

• Registration Number: NCT01828944
• Lead Sponsor: Lesieur

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-11
• Status Verified: 2015-01
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extra virgin olive oil	olive oil	Extra virgin olive oil
Enriched extra virgin olive oil	olive oil	Enriched extra virgin olive oil
refined olive oil	olive oil	refined olive oil

Primary Outcome Measures

Name	Time	Method
Changes in bone mineral density	at baseline and after 9 months of supplementation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Centre de Recherche en Nutrition Humaine; 🇫🇷 Clermont Ferrand, Auvergne, France

Centre d'investigation clinique; 🇫🇷 Marseille, Bouche du Rhône, France