Immunological Impact of High Olive Oil Consumption

Completed · Not applicable · Has a placebo group

Conditions studied: Immune Factors

In brief

This is a prospective, randomized controlled nutrition intervention trial to determine immunological impact of high olive oil consumption in elderly. Aging is associated with impaired immune response which contributes to higher incidence of infections in elderly. Previously the investigators have shown that the type of fatty acids in the diet influences the immune response. In particular, reducing consumption of fats high in n-6 fatty acids has been shown to improve the immune response in aged. Very few studies have evaluated the role of olive oil, the main oil consumed as part of the Mediterranean diet on the immune response of elderly. The investigators hypothesize that high olive oil consumption will improve immune function in elderly. In addition, the investigators will investigate the effect of high olive oil consumption on gene expression of relevant pathways in circulating mononuclear cells, as well as on cognitive function.

Key facts

Study ID

NCT01903304

Run by

Tufts University

People needed

41

Starts

2011-05-01

Expected to finish

2014-05-01

Last updated by the study team

2015-11-05

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must be willing to be randomized into study groups.
• Men and women ≥ 65 years of age.
• Body mass index (BMI) between 25 - 35 kg/m2.
• Consumption of typical American diet.
• Must be willing to stop taking multivitamins, and supplements (with the exception of vitamin D and calcium), including fish oil or n-3 fatty acids and herbal supplements, for 30 days prior to and during study participation, if currently taking these.

You may not qualify if…

• Using olive oil or canola oil as the predominant oil for cooking for the past 6 months, but eligible if willing to stop taking these oils for 30 days prior to participation.
• Currently on a vegetarian diet.
• Eats more than 3 meals per week at a restaurant.
• Consumes fish more than three times per week; but eligible if willing to stop fish consumption 30 days prior to participation and during participation..
• Disordered eating habits:
• "Crash" diets
• Bingeing or food sprees
• Failure to consume a consistent diet, or demonstrates regular changes in patterns of dietary intake.
• Heavy consumption of alcohol (more than 2 glasses of alcoholic drinks per day).
• HIV+ by self-report.
• Autoimmune disease, Type 1 diabetes, celiac disease, inflammatory bowel disease (IBD), multiple sclerosis, rheumatoid arthritis, autoimmune hepatitis.
• Diseases that impact the immune response such as cancer, except for non-melanoma skin cancer, and other neo-plastic diseases.
• Chemotherapy, anti-neo plastic or immunosuppressive drugs.
• Any major illnesses that are uncontrolled (not stable on medication) - uncontrolled liver disease, uncontrolled heart or cardiovascular disease, uncontrolled Hypertension, uncontrolled renal disease, uncontrolled asthma.
• History of smoking or use of nicotine containing products in the past 6 months.
• Active infection within 4 weeks of study enrollment, blood draws or skin tests; however, may participate if admission is postponed or rescheduled > 4 weeks after resolution of symptoms.
• FLU vaccination within 2 weeks prior to study blood draws and skin tests.
• Currently on antibiotics; if on antibiotics need to be off antibiotics for at least 2 weeks before study enrollment, and 2 weeks prior to blood draws up to 48 hrs after DTH implant (i.e. after second reading). .
• Chronic prophylactic antibiotic treatment or long term antibiotics.
• Diagnosis of infections at base¬line will not exclude a subject, but will postpone en¬rollment to 4 wks after symptoms have cleared.
• Participation in weight reduction program within 6 months prior to study enrollment; but include if enrolled in weight loss program to maintain body weight.
• History of splenectomy
• On dialysis
• Conditions or medications associated with maldigestion or malabsorption, including but not limited to (in the opinion of the study physician), inflammatory bowel disease, chronic pancreatitis, celiac disease, resection of the small intestine, gastric bypass or other surgery for weight loss, and use of orlistat.
• Known poor compliance to dietary intervention (based on dietary screening interview).

Where it is running

• Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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