Development of a Novel Method to Study in Vivo Fatty Acid Metabolism Using Stable Isotope Labeled Fatty Acids in Humans

Completed · Not applicable

Conditions studied: Dyslipidemia

In brief

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 enriched in the corresponding fatty acid. Hypothesis: In the fed state, the metabolic fate of 13C18:0 compared to 13C18:1 will be characterized by similar transport, higher conversion, and similar oxidation rates..

Key facts

Study ID

NCT02312492

Run by

Tufts University

People needed

6

Starts

2013-01-01

Expected to finish

2018-12-01

Last updated by the study team

2019-04-18

Who can join

Age: 50 and older, up to 85. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Jean Mayer Human Nutrition Research Center on Aging — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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