Clinical trial NCT01828944: Olive Oil Polyphenols, Vitamin D, Docosahexaenoic Acid (DHA) and Locomotor Function (PolivD3)
Official title: Olive Oil Polyphenols, Vitamin D and Docosahexaenoic Acid (DHA) Synergistic Effects on Locomotor Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Sarcopenia
Keywords: Vitamin D
bone loss
Lead sponsor: Lesieur
Sponsor class: INDUSTRY
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Centre de Recherche en Nutrition Humaine d'Auvergne
First posted: 2013-04-11
Enrollment: 149
Sex: FEMALE
Minimum age (years): 57
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Changes in bone mineral density
timeFrame: at baseline and after 9 months of supplementation
Secondary outcomes:
measure: Changes in serum markers of bone resorption
timeFrame: At baseline, 3 and 9 months
measure: changes in serum markers of bone formation
timeFrame: At baseline, 3 and 9 months
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Centre de Recherche en Nutrition Humaine
state: Auvergne
city: Marseille
country: France
facility: Centre d'investigation clinique
state: Bouche du Rhône
Study officials:
affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Véronique Coxam, PhD
role: STUDY_DIRECTOR
References: