Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition

NCT01251887 | Completed Results

• 2 other identifiers: 11002811-AA-0028
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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 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. Objectives: \- To examine how certain fats in the diet affect body metabolism, hormones, and weight regulation. Eligibility: \- Healthy women between 18 and 50 years of age who are overweight or obese (body mass index between 25 and 35). Design:

• 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. At the visits, participants will have blood and urine tests, complete questionnaires, and have other tests including brain and body imaging studies. 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.
• 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....

Conditions

Weight Gain; Healthy Subjects; Obesity; Women

Keywords

Lipids; Obesity; Omega-3 Fatty Acids; Overweight

Outcome Measures

Primary Outcomes (4)

• Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA)

  Tissue accretion of omega-6 (n-6) highly unsaturated fatty acids (HUFA) in fasting plasma as percent of total HUFA.

  Baseline

• Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA)

  Tissue accretion of omega-6 (n-6) highly unsaturated fatty acids (HUFA) in fasting plasma as percent of total HUFA.

  Week 4

• Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA)

  Tissue accretion of omega-6 (n-6) highly unsaturated fatty acids (HUFA) in fasting plasma as percent of total HUFA.

  Week 8

• Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA)

  Tissue accretion of omega-6 (n-6) highly unsaturated fatty acids (HUFA) in fasting plasma as percent of total HUFA.

  Week 12

Secondary Outcomes (12)

• Proportion of n-6 HUFA Arachidonic Acid (AA)

  Baseline

• Proportion of n-6 HUFA Arachidonic Acid (AA)

  Week 4

• Proportion of n-6 HUFA Arachidonic Acid (AA)

  Week 8

• Proportion of n-6 HUFA Arachidonic Acid (AA)

  Week 12

• Proportion of n-3 HUFA Eicosapentaenoic Acid (EPA)

  Baseline

Study Arms (3)

Diet A: Low omega-3 (n-3) + High linoleic acid (LA)

EXPERIMENTAL

Study diet containing 8 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids (HUFA) for 12 weeks

Dietary Supplement: Linoleic Acid; Dietary Supplement: Docosahexaenoic Acid; Dietary Supplement: Eicosapentaenoic Acid

Diet B: Low omega-3 (n-3) + Low linoleic acid (LA)

EXPERIMENTAL

Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.05 % omega-3 highly unsaturated fatty acids highly unsaturated fatty acids (HUFA) for 12 weeks

Dietary Supplement: Linoleic Acid; Dietary Supplement: Docosahexaenoic Acid; Dietary Supplement: Eicosapentaenoic Acid

Diet C: High omega-3 (n-3) + Low linoleic acid (LA)

EXPERIMENTAL

Study diet containing 1 % energy (en%) linoleic acid (LA), 0.4 % energy (en%) arachidonic acid (AA), 0.81 % omega-3 (n-3) HUFA for 12 weeks

Dietary Supplement: Linoleic Acid; Dietary Supplement: Docosahexaenoic Acid; Dietary Supplement: Eicosapentaenoic Acid

Interventions

Linoleic Acid DIETARY_SUPPLEMENT

Diet A: Low omega-3 (n-3) + High linoleic acid (LA); Diet B: Low omega-3 (n-3) + Low linoleic acid (LA); Diet C: High omega-3 (n-3) + Low linoleic acid (LA)

Docosahexaenoic Acid DIETARY_SUPPLEMENT

Diet A: Low omega-3 (n-3) + High linoleic acid (LA); Diet B: Low omega-3 (n-3) + Low linoleic acid (LA); Diet C: High omega-3 (n-3) + Low linoleic acid (LA)

Eicosapentaenoic Acid DIETARY_SUPPLEMENT

Diet A: Low omega-3 (n-3) + High linoleic acid (LA); Diet B: Low omega-3 (n-3) + Low linoleic acid (LA); Diet C: High omega-3 (n-3) + Low linoleic acid (LA)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Cota D. The role of the endocannabinoid system in the regulation of hypothalamic-pituitary-adrenal axis activity. J Neuroendocrinol. 2008 May;20 Suppl 1:35-8. doi: 10.1111/j.1365-2826.2008.01673.x.

  PMID: 18426497 BACKGROUND

• Pagotto U, Marsicano G, Cota D, Lutz B, Pasquali R. The emerging role of the endocannabinoid system in endocrine regulation and energy balance. Endocr Rev. 2006 Feb;27(1):73-100. doi: 10.1210/er.2005-0009. Epub 2005 Nov 23.

  PMID: 16306385 BACKGROUND

• Szmitko PE, Verma S. The endocannabinoid system and cardiometabolic risk. Atherosclerosis. 2008 Aug;199(2):248-56. doi: 10.1016/j.atherosclerosis.2008.03.011. Epub 2008 Mar 20.

  PMID: 18440538 BACKGROUND

MeSH Terms

Conditions

Weight Gain; Obesity; Overweight

Interventions

Linoleic Acid; Docosahexaenoic Acids; Eicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Linoleic Acids; Fatty Acids, Essential; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Omega-6; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fish Oils; Oils; Eicosanoids

Results Point of Contact

• Title: Ramsden, Christopher
• Organization: NIAAA/NIA

ramsdence@mail.nih.gov

+1 410 558 8369

Study Officials

• Christopher E Ramsden, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: November 12, 2010
• Primary Completion: July 25, 2018
• Study Completion: July 25, 2018
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2018-07-25

Locations

US (1)