Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition
- 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 understand how weight might be controlled, it is important to learn what kinds of dietary changes can affect hunger and might lower body weight. Essential fatty acids, for instance, are an important part of a healthy diet, but researchers have not yet determined the ideal amount of essential fatty acids that people should eat. By studying how different diets affect body chemistry and hormone levels in women who are overweight or obese, researchers hope to be able to determine better diets or treatments to help people reach and maintain an optimum healthy weight.
- To examine how certain fats in the diet affect body metabolism, hormones, and weight regulation.
- Healthy women between 18 and 50 years of age who are overweight or obese (body mass index between 25 and 35).
- This study has an initial screening visit and three phases. All participants will be involved in the first two phases of the study, and some participants will be involved in the third phase.
- Participants will be screened with a physical examination and medical history, in addition to blood and urine tests and questionnaires about eating habits and other diet factors.
- Phase 1: Participants will have three visits to the National Institutes of Health over a 4-week period (some may have a 36-hour inpatient evaluation visit as well). At the visits, participants will have blood and urine tests, complete questionnaires, and have other tests including brain and body imaging studies. The 36-hour inpatient stay will measure hormone and food metabolism. Participants will then be assigned to one of three study diets.
- Phase 2: Participants will have a 12-week diet phase, with all foods supplied by the study researchers. Participants will keep a daily log of food and beverage intake, and will have three testing sessions with procedures similar to those performed in Phase 1. The same participants who had the 36-hour inpatient stay will have another 36-hour stay.
- Phase 3: Participants assigned to a particular study diet (one-third of all participants) will be given the option of continuing the diet for an additional 36 weeks (9 months), with food consumption, monitoring, and testing procedures similar to those performed in Phase 2....
Dietary Supplement: Linoleic Acid
Dietary Supplement: Docosahexaenoic Acid
Dietary Supplement: Eicosapentaenoic Acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Dietary Linoleic Acid Regulation of Omega-3HUFA Metabolism: Satiety and Body Composition Among Overweight Female Subjects|
- The primary outcomes will be the proportion of n-6 HUFA in total HUFA (%n-6 in HUFA) and two endocannabinoids derived from n-6 AA, 2-Arachidonoylglycerol (2-AG) and N-Arachidonoylethanolamine(Anandamide or AEA).
- Secondary outcome measures will include blood concentrations of the n-6 HUFA Arachidonic Acid (AA); the 3-n HUFA Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA).
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||June 2020|
|Estimated Primary Completion Date:||June 2020 (Final data collection date for primary outcome measure)|
Dietary Supplement: Linoleic Acid
|Contact: Christopher E Ramsden, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Christopher E Ramsden, M.D.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|