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Completed

NCT Number: NCT01828944

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

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.

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Key information

Conditions

Osteopenia Atrophy Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

57 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche en Nutrition Humaine, Clermont-Ferrand, Auvergne, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olive Oil

Dietary Supplement

Primary outcomes

  1. Changes in bone mineral density

    Time frame: at baseline and after 9 months of supplementation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lesieur

Industry

Collaborators

  • Centre de Recherche en Nutrition Humaine d'Auvergne
  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Registry information

Official study title

Olive Oil Polyphenols, Vitamin D and Docosahexaenoic Acid (DHA) Synergistic Effects on Locomotor Function

Acronym: PolivD3

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 11, 2013
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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