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

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ClinicalTrials.gov Identifier: NCT01828944
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 29, 2015
Sponsor:
Collaborators:
Institut National de la Recherche Agronomique
Centre de Recherche en Nutrition Humaine d'Auvergne
Information provided by (Responsible Party):
Lesieur

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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



Primary Outcome Measures :
  1. Changes in bone mineral density [ Time Frame: at baseline and after 9 months of supplementation ]

Secondary Outcome Measures :
  1. Changes in serum markers of bone resorption [ Time Frame: At baseline, 3 and 9 months ]
  2. changes in serum markers of bone formation [ Time Frame: At baseline, 3 and 9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   57 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828944


Locations
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France
Centre de Recherche en Nutrition Humaine
Clermont Ferrand, Auvergne, France, 63000
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
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Study Director: Véronique Coxam, PhD Institut National de la Recherche Agronomique
Additional Information:
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Responsible Party: Lesieur
ClinicalTrials.gov Identifier: NCT01828944    
Other Study ID Numbers: AU961
2012-A00344-39 [N°IDRCB] ( Other Identifier: French Health Agency )
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: January 2015
Keywords provided by Lesieur:
Vitamin D
bone loss
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases