Immune FactorsOOSNCT01903304
Immunological Impact of High Olive Oil Consumption
A study testing Olive Oil in people with Immune Factors, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Factors
- What is being tested?
- Olive Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 28Show fewer
- 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).
- Unwillingness to maintain current body weight and level of physical activity during the study period.
- Consumption of herbal supplements. Interested eligible participants on herbal supplements will be asked to stop taking these while on the study after a 30 day washout period.
- Use of aspirin, non-steroidal anti-inflammatory medications (NSAIDs) or antihistamine prescribed by a physician or clinician, or the inability to discontinue the use of these substances for 72 hrs before first day blood draw until 48 hrs after DTH implant (i.e. after second reading).
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
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.
Read the detailed description
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: [1] Control Typical American Diet A, (N=20) and [2] 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.
- Conditions
- Immune Factors
- Being tested
- Olive Oil
- Keywords
- Olive oil, DTH, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive OilOther
3 months intervention
| Study group | Role | What they receive |
|---|---|---|
| olive oil | Experimental | intervention with olive oil for 3 months Receives: Other: Olive Oil |
| Placebo | Placebo comparator | Intervention with placebo for 3 months Receives: Other: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and month 3
Secondary outcomes (1)
change in plasma inflammation markers
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
Measured: Baseline and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Spain
- Responsible party
- Principal investigator, Simin Meydani, Tufts University
- Investigators
- Simin N Meydani, DVM, PhD, Principal investigator, Human Nutrition Research Center on AgingJunaidah B Barnett, MCH(N), PhD, Study director, Human Nutrition Research Center on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903304
- Sponsor's protocol ID
- FRGN64
- Acronym
- OOS
- Status last verified
- Nov 2015
- First submitted
- 4 Dec 2011
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26251666
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Impact of High Olive Oil Consumption
- ClinicalTrials.gov ID
- NCT01903304
- Acronym / sponsor ID
- OOS / FRGN64
- Conditions
- Immune Factors
- Keywords
- Olive oil, DTH, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Research Council, Spain
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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: [1] Control Typical American Diet A, (N=20) and [2] 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olive oil | Experimental | Other: Olive Oilintervention with olive oil for 3 months |
| Placebo | Placebo comparator | Other: Olive OilIntervention with placebo for 3 months |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (28 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive Oil3 months intervention | Other | Placebo, olive oil |
Primary outcome
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.
1 secondary outcome
change in plasma inflammation markers
Time frame: Baseline and month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Background: PubMed 26251666Rozati 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simin N Meydani, DVM, PhD principal investigator
Human Nutrition Research Center on Aging
Junaidah B Barnett, MCH(N), PhD study director
Human Nutrition Research Center on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive Oil in people with Immune Factors, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in delayed hypersensitivity skin-test (DTH) (time frame: baseline and month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01903304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.