Immunological Impact of High Olive Oil Consumption (OOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01903304|
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : November 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Immune Factors||Other: Olive Oil||Not Applicable|
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 we 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. We hypothesize that high olive oil consumption will improve immune function in elderly. In addition, we 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.
Subject recruitment and enrollment will be conducted at the USDA HNRCA. Following screening, 40 eligible overweight or obese participants aged 65 and above will be randomized into one of two nutrition intervention groups for a period of 12 weeks:  Control Typical American Diet A, (N=20) and  Experimental Diet B (N=20).
Participants on the Control Diet A will be consuming a low-fiber, high-fat typical American Diet. Those on Diet B will consume a similar diet as the typical American diet, but they will be asked to replace their oil intake with extra virgin olive oil. Dietary counseling will be provided by the study dietitian at the Metabolic Research Kitchen of the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) at Tufts University on where the study oils will be replacing oils in the subjects' diets. Subjects will be followed regularly by the study dietitian throughout the intervention period to provide support and ensure compliance to study protocol. Data collection will take place at baseline, and after the subjects have been on the study diets for a period of three months. Data collection for the study outcome measures of interest will comprise blood drawing, anthropometric measurements, and cellular and immune factors. Specifically, measures will include:
- in vivo indices of T cell-mediated function [delayed type hypersensitivity (DTH)],
- plasma inflammation markers (such as IL-1b, IL-6, TNF-a, CRP, MCP-1, sICAM-1, and sVCAM-1),
- ability of T cells and their subsets (such as CD4 and CD8, naïve and memory) to proliferate,
- Ex vivo production cytokines and PGE2 by immune cells.
- Gene expression of relevant pathways using transcriptomics analysis in circulating mononuclear cells.
- The CANTAB (Cambridge Cognition Ltd, Tunbridge Court, Tunbridge Lane, Bottisham, Cambridge, CB25 9TU, UK) is a computerized cognitive assessment, and
- Beck Depression Inventory.
This study will be conducted by the Nutritional Immunology Lab, with Dr. Simin Meydani as the PI and Drs. Barnett (Project director), Wu (Lab Director), Dallal (Biostatistician), Saltzman (Study Physician), Sen, Scott, and Ordovas as Co-Investigators. Dr. Ascension Marcos of the Scientific National Research Council (CSIC) is also a Co-I of this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Immunological Impact of High Olive Oil Consumption|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2014|
Experimental: olive oil
intervention with olive oil for 3 months
Other: Olive Oil
3 months intervention
Placebo Comparator: Placebo
Intervention with placebo for 3 months
Other: Olive Oil
3 months intervention
- change in delayed hypersensitivity skin-test (DTH) [ Time Frame: baseline and month 3 ]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.
- change in plasma inflammation markers [ Time Frame: Baseline and month 3 ]Blood will be collected at baseline and 3-mo after supplementation to determine IL-1b, IL-6, TNF-a, CRP, MCP-1, sICAM-1, and sVCAM-1 levels in the plasma, which provide an in vivo status of inflammation associated with metabolic syndrome
- change in ability of T cells and their subsets (such as CD4 and CD8, naïve and memory) to proliferate [ Time Frame: baseline and month 3 ]Blood will be collected at baseline and 3-mo after supplementation and peripheral blood mononuclear cells (PBMC) will be isolated. PBMC will be labeled with the tracking dye CFSE and stimulated for 3 days. The cells will be labeled with appropriate antibodies to identify the sub-populations of T cells (CD4 and CD8, naïve and memory) and combined with CFSE tracking, proliferation profile of each sub-population will be obtained.
- change in ex vivo production of cytokines and PGE2 by immune cells [ Time Frame: baseline and month 3 ]Blood will be collected at day 1 and day 2 (duplicate sampling to counter day to day variation in this type of assays) of both baseline and 3-mo after supplementation. Whole blood culture will be stimulated to determine the ability of T cells to proliferate and of immune cells to produce cytokines and PGE2.
- change in gene expression of relevant pathways using transcriptomics analysis in circulating mononuclear cells. [ Time Frame: baseline and month 3 ]Five milliliters blood samples will be collected in the fasting state both at baseline and following 3 months of dietary intervention. Total RNA from mononuclear cells will be isolated and processed to Biotin labeled cRNA at the Nutritional Genomics Lab, JM HNRCA at Tufts University. We will use the GenMapp 2.1 and MappFinder 2.0 software package (www.GenMapp.org) for the Gene Ontology (GO) and pathway analysis.
- change in cognitive function using the CANTAB (Cambridge Cognition Ltd, Tunbridge Court, Tunbridge Lane, Bottisham, Cambridge, CB25 9TU, UK) computerized cognitive assessment tool. [ Time Frame: baseline and month 3 ]We have chosen the following CANTAB modules to assess attention, memory, language and executive function.
- change in measure using Beck Depression Inventory [ Time Frame: baseline and month 3 ]At baseline and the 3 month follow-up, participants will be tested for cognitive function and will be administered the Beck Depression Inventory - II.
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): NCT01903304
|United States, Massachusetts|
|Human Nutrition Research Center on Aging at Tufts University|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Simin N Meydani, DVM, PhD||Human Nutrition Research Center on Aging|
|Study Director:||Junaidah B Barnett, MCH(N), PhD||Human Nutrition Research Center on Aging|