- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145936
Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation
July 12, 2018 updated by: Tufts University
Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation.
The purpose of this study is to to determine the effect of habituation to diets with different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular Disease (CVD) risk indicators with an emphasis on inflammation.
Study Overview
Detailed Description
Vegetable oils high in the specific fatty acids of interest - stearic (found in cocoa butter, meats), palmitic (found in meats, dairy and some plant oils) and stearic acid's metabolic product, oleic (found in olive and corn oil) - will be used to displace each other in a standardized diet and fed to mildly hypercholesterolemic postmenopausal women using a randomized-controlled crossover design.
A critical issue remains unresolved - the relative comparability among .
The findings from this research study will enable us to understand the mechanism and potential health effect of different types of fats.
Each of the diet phases will be 5 weeks in length with a 2-4 week break between phases.
All food and drink will be provided to study volunteers.
Blood pressure and body weight will be monitored once per week and adjustments made, if necessary, to maintain a stable weight.
During the 5th week of each diet phase, volunteers will come to the center on 3 consecutive days to provide fasting blood samples and a non-fasting blood sample.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Jean Mayer Human Nutrition Research Center on Aging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
The inclusion and exclusion criteria for both studies A and B are identical.
- Postmenopausal women (menopause defined by complete natural cessation of menses for >12 months or a bilateral oophorectomy).
- Age >50 to < 85 years
- BMI >20 to <35 kg/m2
- LDL-cholesterol >100 mg/dL
- CRP <10 ug/dL
- Normal fasting plasma glucose levels (<120 mg/dL)
- Not taking medication known to affect lipid metabolism:
HMG-CoA reductase inhibitors (statins)
- Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
- Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
- Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
- Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
- Probucol
- Anticoagulants (Coumadin, Heparin, Plavix, etc)
- Hormone therapy medications containing estrogen
- Acetylsalicylic acid containing medications, aspirin
- Diphenylhydantoin
- Supplements containing fatty acids (Fish Oil, Flaxseed, etc.) and any other compounds that affect lipid metabolism (red yeast rice, etc.) for at least 3 months prior to participation in the study
- Anabolic steroids
Hydrocortisone
- Normal kidney function as assessed by serum creatinine and blood urea nitrogen
- Normal liver function as assessed by serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase and alkaline phosphatase
- Normal thyroid function as assessed by serum TSH
- Normal gastrointestinal function
- Normotensive on or off medication
- Non-smoker for at least 2 years
- Alcohol intake < 7 drinks per week, and willingness to abstain from consuming alcohol while participating in the study.
- Consistent physical activity
- Willingness to follow protocol as detailed in the Institutional Review Board (IRB) approved consent form.
Exclusion criteria:
- Men
- Women who have had a double mastectomy
- Age < 50 and > 85 years
- BMI < 20 and > 35 kg/m2
- LDL-cholesterol <100 mg/dL
- CRP > 10 ug/dL
- Abnormal fasting plasma glucose levels >120 mg/dL
Use of medications known to affect lipid metabolism:
- HMG-CoA reductase inhibitors (statins)
- Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
- Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
- Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
- Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
- Anticoagulants (Coumadin, Heparin, Plavix, etc)
- Hormone therapy medications containing estrogen
- Probucol
- Acetylsalicylic acid containing medications, aspirin
- Diphenylhydantoin
- Supplements containing fatty acids (Fish Oil, Flaxseed, etc.) and any other compounds that affect lipid metabolism (red yeast rice, etc.) in the last 3 months prior to participation in the study
- Anabolic steroids and hydrocortisone
- Renal or kidney disease, as defined by a history of chronic kidney disease or by glomerular filtration rate of < 60 ml.min/1.73 m2 calculated from screening blood tests.
- Hypothyroidism or hyperthyroidism, as defined as screening TSH outside of normal ranges (<0.4 or >4.5), unless controlled with medication for at least 6 months
- Gastrointestinal disease
- Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
- Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
- Anemia, as defined by screening haemoglobin <11.7g/dL.
- Liver disease, as defined by a history of chronic hepatitis B or C, cholestatic or cirrhotic liver disease, nonalcoholic fatty liver disease, elevations of SGPT or SGOT greater than 1.5 times the upper limit of normal at screening, bilirubin greater than 2 mg/dL (in the absence of benign causes of elevated bilirubin such as Gilbert's syndrome) at screening, or albumin below the lower limit of normal.
- Type I and II diabetes
- Any non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use by subject for 72 hours prior to blood draws
- Smoking or use of nicotine-containing products within the past 2 years
- Alcohol intake > 7 drinks per week or unwillingness to abstain from consuming alcohol while participating in the study
- Unwillingness to maintain body weight during participation in the study
- Unwillingness to adhere to diet and study protocol
- Weight gain or loss of more than 15 lb within 6 months prior to enrollment
- Vegetarians and those with food allergies or aversions
- Non-English speaking subjects
- No Social Security number
- Women who have a history of difficulty with blood draws
- Blood donation within the past 8 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: oleic acid diet
Participants are provided with meals enriched in oleic acid (18:1)
|
Participants are fed diets enriched in oleic acid, palmitic acid or stearic acid.
|
Experimental: palmitic acid diet
Participants are provided with meals enriched in palmitic acid (18:0)
|
Participants are fed diets enriched in oleic acid, palmitic acid or stearic acid.
|
Experimental: stearic acid diet
Participants are provided with meals enriched in stearic acid (18:0)
|
Participants are fed diets enriched in oleic acid, palmitic acid or stearic acid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
inflammation
Time Frame: 15-weeks
|
interleukine (IL)-6, tumor necrosis factor (TNF)-alpha, monocyte chemoattractant protein (MCP)-1, C-reactive protein (CRP), soluble forms of intercellular adhesion protein (slCAM)-1, vascular cell adhesion protein (sVCAM)-1, sE-selectin, sP-selectin and li0poprotein associated phospholipase A2 (LpPLA2).
|
15-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lymphocyte proliferation and ex vivo cytokine secretion
Time Frame: 15 weeks
|
IL-1, IL-6, TNF-alpha, and prostaglandin E2 (PGE2)
|
15 weeks
|
plasma lipids and lipoproteins
Time Frame: 15 weeks
|
TC, HDL, LDL
|
15 weeks
|
desaturase activity
Time Frame: 15 weeks
|
8CD, D6D, D5D
|
15 weeks
|
insulin sensitivity
Time Frame: 15 weeks
|
glucose, insulin
|
15 weeks
|
coagulation biomarkers
Time Frame: 15 weeks
|
prothrombin time (PT), partial thromboplastin time (PTT)
|
15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alice H Lichtenstein, D.Sc., Tufts University/HNRCA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
February 3, 2012
First Submitted That Met QC Criteria
May 20, 2014
First Posted (Estimate)
May 23, 2014
Study Record Updates
Last Update Posted (Actual)
July 13, 2018
Last Update Submitted That Met QC Criteria
July 12, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1541 - Fatty Acid Pilot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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