Status:
COMPLETED
Palmitoleic Isomer Study
Lead Sponsor:
Tufts University
Conditions:
Insulin Sensitivity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Trans-palmitoleic acid (trans-C16:1) is a naturally occurring trans fatty acid present in small quantities in foods, most notably in dairy products. Observational evidence suggests a positive associat...
Detailed Description
The fatty acids trans-C16:1 and cis-C16:1 have been associated with healthy plasma glucose levels. Elevated glucose levels have been associated with diabetes. This study is designed to determine wheth...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥ 18 to ≤ 70 years
- BMI ≥ 25 kg/m2 ≤ 40 kg/m2
- Normotensive with or without medication
- Normal fasting plasma glucose levels (≤120 mg/dL)
- Normal kidney function as assessed by serum creatinine and blood urea nitrogen
- Normal liver function as assessed by serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase (ALP)
- Normal thyroid function defined as screening TSH within normal ranges, without or with medication for at least 6 months
- Normal gastrointestinal function
- Exclusion criteria:
- Use of supplements containing fish oil or other lipid supplements (e.g., flaxseed, primrose oil, sea buckthorn oil) within 3 months of study participation
- Greater than 2 servings/day combined of cheese, whole-fat milk or whole-fat yogurt
- Diagnosed diabetes mellitus Type I or Type II and/or taking glucose lowering medications (e.g., metformin, actos, januvia)
- Use of medication known to affect lipid metabolism (HMG-CoA reductase inhibitors (statins, red yeast rice), bile acid sequestrants, cholesterol absorption inhibitors (exetimibe \[Zetia\]), nicotinic acid agents, fibrates, probucol, anticoagulants, hormone therapy medications containing estrogen, anabolic steroids)
- Established major chronic diseases such as major cardiovascular disease (history of myocardial infarction, stroke, symptomatic heart failure, coronary artery bypass graft, or symptomatic peripheral arterial disease), active cancer, end stage renal disease, dementia, severe chronic obstructive pulmonary disease, significant liver disease
- Pregnancy or breastfeeding
- Unwillingness to adhere to study protocol
- No Social Security number (for payment and IRS forms).
Exclusion
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02311790
Start Date
July 1 2015
End Date
April 1 2017
Last Update
September 1 2017
Active Locations (1)
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1
Jean Mayer Human Nutrition Research Center on Aging
Boston, Massachusetts, United States, 02111