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

Lesieur

Status: Completed

Conditions: Osteopenia; Sarcopenia

Treatments: Dietary Supplement: olive oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01828944

AU961

2012-A00344-39 [N°IDRCB] (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: Female

Ages: 57 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 3 patient groups, including a placebo group

Extra virgin olive oil

Active Comparator group

Description:

Extra virgin olive oil

Treatment:

Dietary Supplement: olive oil

Enriched extra virgin olive oil

Experimental group

Description:

Enriched extra virgin olive oil

Treatment:

Dietary Supplement: olive oil

refined olive oil

Placebo Comparator group

Description:

refined olive oil

Treatment:

Dietary Supplement: olive oil