Immunological Impact of High Olive Oil Consumption

NCT01903304 | Completed

• 1 other identifier: FRGN64
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immune Factors

Keywords

Olive oil; DTH; elderly

Outcome Measures

Primary Outcomes (1)

• change in delayed hypersensitivity skin-test (DTH)

  Subjects will be tested for the DTH skin response to 3 antigens (tricophyton, tetanus, and candida, plus saline as control) at baseline and 3-mo after supplementation.

  baseline and month 3

Secondary Outcomes (1)

• change in plasma inflammation markers

  Baseline and month 3

Other Outcomes (5)

• change in ability of T cells and their subsets (such as CD4 and CD8, naïve and memory) to proliferate

  baseline and month 3

• change in ex vivo production of cytokines and PGE2 by immune cells

  baseline and month 3

• change in gene expression of relevant pathways using transcriptomics analysis in circulating mononuclear cells.

  baseline and month 3

Study Arms (2)

olive oil

EXPERIMENTAL

intervention with olive oil for 3 months

Other: Olive Oil

Placebo

PLACEBO COMPARATOR

Intervention with placebo for 3 months

Other: Olive Oil

Interventions

Olive Oil OTHER

3 months intervention

Placebo; olive oil

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Tufts University: lead
• National Research Council, Spain: collaborator

Study Sites (1)

Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Rozati M, Barnett J, Wu D, Handelman G, Saltzman E, Wilson T, Li L, Wang J, Marcos A, Ordovas JM, Lee YC, Meydani M, Meydani SN. Cardio-metabolic and immunological impacts of extra virgin olive oil consumption in overweight and obese older adults: a randomized controlled trial. Nutr Metab (Lond). 2015 Aug 7;12:28. doi: 10.1186/s12986-015-0022-5. eCollection 2015.

  PMID: 26251666 BACKGROUND

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Simin N Meydani, DVM, PhD

  Human Nutrition Research Center on Aging

  PRINCIPAL INVESTIGATOR

• Junaidah B Barnett, MCH(N), PhD

  Human Nutrition Research Center on Aging

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2011
• First Posted: July 19, 2013
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: November 5, 2015

Record last verified: 2015-11

Locations

US (1)