Status:
COMPLETED
Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Weight Gain
Healthy Subjects
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Background: \- Rates of obesity have increased dramatically in recent decades, and researchers are investigating how changes in diets and physical activity have contributed to this increase. To under...
Detailed Description
Objective To evaluate the effects of lowering the dietary nutrient linoleic acid (LA) as a controlled variable on: 1) tissue accretion of omega-6 and omega-3 highly unsaturated fatty acids (HUFA); 2)...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects will be overweight, but otherwise healthy, pre-menopausal ambulatory volunteers aged 18 to 50.
- To be eligible for this research study, participants must:
- Be between 18 and 50 years of age.
- Have regular menstrual cycles.
- Be willing to use an effective method of birth control such as hormonal contraception, intrauterine device, barrier methods combined with spermicide, or surgical sterilization.
- Have a body mass index of 25 to 35 kg/m(2).
- Be otherwise healthy as determined by history, medical examination and laboratory tests.
- Be able to come to the NIH Clinical Center every weekday for 3 months.
- Be able to understand the consent form, and provide informed written consent.
- EXCLUSION CRITERIA:
- Participants are not eligible for this research study if they:
- Have been pregnant or have breast fed within the last 2 years.
- Work, or have an immediate family member who works, with a study investigator. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- Are HIV positive.
- Have any current, unstable medical conditions including respiratory insufficiency requiring oxygen therapy; cardiac ischemia; cardiac or hepatic failure; or acute neurological illness as assessed by history and physical exam.
- Have evidence of diseases that may influence metabolism (e.g. overt diabetes mellitus, thyroid disease, cancer)
- Have any current or past history of eating disorders such as binge eating or anorexia nervosa.
- Have had weight loss (bariatric) surgery.
- Have gained or lost more than 3% of your current weight in the past 3 months.
- Exercise strenuously, like running, swimming, or basketball, 4 or more times per week.
- Are planning to begin a strenuous exercise program in the next 4 months.
- Take supplements that contain omega-6 or omega-3 fatty acids (e.g. fish, cod liver, borage, evening primrose oils)
- Have significant dietary limitations (e.g. multiple food allergies/intolerances, vegan diet) or special dietary requirements that are difficult to accommodate with study diets
- Have significant claustrophobia that would preclude study tests.
- Have a history of alcohol or substance abuse or dependence in the past 5 years.
- Drink more than 2 alcoholic beverages per day, on average, or 6 drinks per sitting in the past year. Participants may drink up to one alcoholic beverage per day during the study.
- Used marijuana, amphetamines, cocaine, or heroin even once over the last year. Participants may not use marijuana, amphetamines, cocaine, or heroin during the study.
- Have smoked 2 or more cigarettes per week, on average, over the past year.
- Participants may not use tobacco products during the study.
- Eat fish 3 or more times per week on average.
- Have a known bleeding disorder.
- Take medications or supplements that may interfere with this study by altering energy metabolism, nutrient absorption, or food intake. Regular use of the following compounds warrants exclusion: medications for the management of diabetes (Type 1 or 2), typical and atypical antipsychotics, thyroid medications, glucocorticoids, orlistat, decongestants, anti-histamines, and medications for cardiac conditions (e.g. beta blockers), attention disorders (e.g. amphetamine derivatives), blood lipid disorders (e.g. statins, fibrates), and hypertension (e.g. thiazide diuretics), as well as certain anti-depressants (e.g. tricyclics), and supplements that impact energy metabolism, such as ephedrine.
- Regularly take an anticoagulant medication, such as warfarin or aspirin.
- Have a pacemaker, brain stimulator, or other implanted electrical device, permanent eyeliner, metallic prosthesis (including metal pins and rods, heart valves, and cochlear implants) that would preclude MRI scans.
- Are currently participating in any other clinical research studies that include blood draws or other procedures.
- Have a serum follicle-stimulating hormone (FSH) level greater than 20 units per liter
Exclusion
Key Trial Info
Start Date :
November 12 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2018
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01251887
Start Date
November 12 2010
End Date
July 25 2018
Last Update
September 5 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892