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

Sarcopenia Clinical Trial

— PolivD3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828944
• Other study ID #: AU961
• Secondary ID: 2012-A00344-39 [
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 28, 2015
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: January 2015
• Source: Lesieur
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : National Health Products Safety AgencyFrance: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 57 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia
• Sarcopenia

Intervention

Dietary Supplement:
• olive oil

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine	Clermont Ferrand	Auvergne
France	Centre d'investigation clinique	Marseille	Bouche du Rhône

Sponsors (3)

Lead Sponsor	Collaborator
Lesieur	Centre de Recherche en Nutrition Humaine d'Auvergne, Institut National de la Recherche Agronomique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in bone mineral density		at baseline and after 9 months of supplementation	No
Secondary	Changes in serum markers of bone resorption		At baseline, 3 and 9 months	No
Secondary	changes in serum markers of bone formation		At baseline, 3 and 9 months	No

External Links

•   Link