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

Primary Purpose

Osteopenia, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
olive oil
Sponsored by
Lesieur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia focused on measuring Vitamin D, bone loss

Eligibility Criteria

57 Years - 79 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de Recherche en Nutrition Humaine
  • Centre d'investigation clinique

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Extra virgin olive oil

Enriched extra virgin olive oil

refined olive oil

Arm Description

Extra virgin olive oil

Enriched extra virgin olive oil

refined olive oil

Outcomes

Primary Outcome Measures

Changes in bone mineral density

Secondary Outcome Measures

Changes in serum markers of bone resorption
changes in serum markers of bone formation

Full Information

First Posted
April 2, 2013
Last Updated
April 28, 2015
Sponsor
Lesieur
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Centre de Recherche en Nutrition Humaine d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT01828944
Brief Title
Olive Oil Polyphenols, Vitamin D, Docosahexaenoic Acid (DHA) and Locomotor Function (PolivD3)
Acronym
PolivD3
Official Title
Olive Oil Polyphenols, Vitamin D and Docosahexaenoic Acid (DHA) Synergistic Effects on Locomotor Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lesieur
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Centre de Recherche en Nutrition Humaine d'Auvergne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia, Sarcopenia
Keywords
Vitamin D, bone loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extra virgin olive oil
Arm Type
Active Comparator
Arm Description
Extra virgin olive oil
Arm Title
Enriched extra virgin olive oil
Arm Type
Experimental
Arm Description
Enriched extra virgin olive oil
Arm Title
refined olive oil
Arm Type
Placebo Comparator
Arm Description
refined olive oil
Intervention Type
Dietary Supplement
Intervention Name(s)
olive oil
Primary Outcome Measure Information:
Title
Changes in bone mineral density
Time Frame
at baseline and after 9 months of supplementation
Secondary Outcome Measure Information:
Title
Changes in serum markers of bone resorption
Time Frame
At baseline, 3 and 9 months
Title
changes in serum markers of bone formation
Time Frame
At baseline, 3 and 9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
57 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Coxam, PhD
Organizational Affiliation
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Official's Role
Study Director
Facility Information:
Facility Name
Centre de Recherche en Nutrition Humaine
City
Clermont Ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France
Facility Name
Centre d'investigation clinique
City
Marseille
State/Province
Bouche du Rhône
ZIP/Postal Code
13005
Country
France

12. IPD Sharing Statement

Links:
URL
http://www1.clermont.inra.fr/crnh/
Description
Related Info

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

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