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

• Sponsor: Lesieur (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01828944
• Collaborator: Institut National de la Recherche Agronomique (Other), Centre de Recherche en Nutrition Humaine d'Auvergne (Other)
• Enrollment: 149
• Locations: 2
• Arms: 3
• Duration (Months): 28
• Patients Per Site: 74.5
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia; Sarcopenia	Dietary Supplement: olive oil	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 149 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Olive Oil Polyphenols, Vitamin D and Docosahexaenoic Acid (DHA) Synergistic Effects on Locomotor Function
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Extra virgin olive oil Extra virgin olive oil	Dietary Supplement: olive oil
Experimental: Enriched extra virgin olive oil Enriched extra virgin olive oil	Dietary Supplement: olive oil
Placebo Comparator: refined olive oil refined olive oil	Dietary Supplement: olive oil

Outcome Measures

Primary Outcome Measures

1. Changes in bone mineral density [at baseline and after 9 months of supplementation]

Secondary Outcome Measures

1. Changes in serum markers of bone resorption [At baseline, 3 and 9 months]

2. changes in serum markers of bone formation [At baseline, 3 and 9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 57 Years to 79 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de Recherche en Nutrition Humaine	Clermont Ferrand	Auvergne	France	63000
2	Centre d'investigation clinique	Marseille	Bouche du Rhône	France	13005

Sponsors and Collaborators

• Lesieur
• Institut National de la Recherche Agronomique
• Centre de Recherche en Nutrition Humaine d'Auvergne

Investigators

• Study Director: Véronique Coxam, PhD, Institut National de la Recherche Agronomique

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Lesieur
• ClinicalTrials.gov Identifier: NCT01828944
• Other Study ID Numbers: AU961; 2012-A00344-39 [N°IDRCB]
• First Posted: Apr 11, 2013
• Last Update Posted: Apr 29, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Lesieur: Vitamin D; bone loss
• Additional relevant MeSH terms: Bone Diseases, Metabolic; Sarcopenia

Study Results

No Results Posted as of Apr 29, 2015