NCT01828944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 29, 2015

Status Verified

January 1, 2015

Enrollment Period

2.3 years

First QC Date

April 2, 2013

Last Update Submit

April 28, 2015

Conditions

OsteopeniaSarcopenia

Keywords

Vitamin Dbone loss

Outcome Measures

Primary Outcomes (1)

  • Changes in bone mineral density

    at baseline and after 9 months of supplementation

Secondary Outcomes (2)

  • 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

Study Arms (3)

Extra virgin olive oil

ACTIVE COMPARATOR

Extra virgin olive oil

Dietary Supplement: olive oil

Enriched extra virgin olive oil

EXPERIMENTAL

Enriched extra virgin olive oil

Dietary Supplement: olive oil

refined olive oil

PLACEBO COMPARATOR

refined olive oil

Dietary Supplement: olive oil

Interventions

olive oilDIETARY_SUPPLEMENT
Enriched extra virgin olive oilExtra virgin olive oilrefined olive oil

Eligibility Criteria

Age57 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de Recherche en Nutrition Humaine

Clermont-Ferrand, Auvergne, 63000, France

Location

Centre d'investigation clinique

Marseille, Bouche Du Rhône, 13005, France

Location

Related Links

MeSH Terms

Conditions

Bone Diseases, MetabolicSarcopenia

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Véronique Coxam, PhD

    Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 11, 2013

Study Start

December 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 29, 2015

Record last verified: 2015-01

Locations

FR(2)