Status:
COMPLETED
Development of a Novel Method to Study in Vivo Fatty Acid Metabolism Using Stable Isotope Labeled Fatty Acids in Humans
Lead Sponsor:
Tufts University
Conditions:
Dyslipidemia
Eligibility:
FEMALE
50-85 years
Phase:
NA
Brief Summary
Specific Aim 1: To compare the metabolic fate (transport, conversion and oxidation) of labeled 18:0 (13C18:0) and its metabolic product 18:1 (13C18:1) in the fed state after habituation to diets enric...
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 (...
Eligibility Criteria
Inclusion
- 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 (C reactive protein) \<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 (thyroid stimulating hormone)
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02312492
Start Date
January 1 2013
End Date
December 1 2018
Last Update
April 18 2019
Active Locations (1)
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1
Jean Mayer Human Nutrition Research Center on Aging
Boston, Massachusetts, United States, 02111