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NCT01251887

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

Completed NA Results posted Last updated 5 September 2021
What this trial tests

NA trial testing Linoleic Acid in Weight Gain in 85 participants. Completed in 25 July 2018.

Timeline
12 November 2010
Primary endpoint
25 July 2018
25 July 2018

Quick facts

Lead sponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Primary purposetreatment
Enrollment85
Start date12 November 2010
Primary completion25 July 2018
Estimated completion25 July 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Who can join

Adults 18 to 50, female only, with Weight Gain or Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA) Primary · Baseline

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

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)80.0± 1.2
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)81.3± 0.9
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)80.5± 1.1
Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA) Primary · Week 4

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

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)80± 1.1
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)80.7± 0.9
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)70.6± 1.1
Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA) Primary · Week 8

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

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)79.7± 1.2
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)80.6± 0.9
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)70.8± 1.1
Proportion of n-6 HUFA in Total HUFA (%n-6 in HUFA) Primary · Week 12

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

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)80.6± 1.1
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)81± 0.9
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)72.9± 1.1
Proportion of n-6 HUFA Arachidonic Acid (AA) Secondary · Baseline

Tissue accretion of Arachidonic Acid (AA or 20:4n6), an omega-6 (n-6) highly unsaturated fatty acid, as measured in fasting plasma as a percent of total fatty acids.

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)6.42± 0.3
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)6.51± 0.22
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)7.12± 0.29
Proportion of n-6 HUFA Arachidonic Acid (AA) Secondary · Week 4

Tissue accretion of Arachidonic Acid (AA or 20:4n6), an omega-6 (n-6) highly unsaturated fatty acid, as measured in fasting plasma as a percent of total fatty acids.

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)6.25± 0.29
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)7.02± 0.22
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)6.37± 0.28
Proportion of n-6 HUFA Arachidonic Acid (AA) Secondary · Week 8

Tissue accretion of Arachidonic Acid (AA or 20:4n6), an omega-6 (n-6) highly unsaturated fatty acid, as measured in fasting plasma as a percent of total fatty acids.

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)6.59± 0.30
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)7.27± 0.23
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)6.40± 0.28
Proportion of n-6 HUFA Arachidonic Acid (AA) Secondary · Week 12

Tissue accretion of Arachidonic Acid (AA or 20:4n6), an omega-6 (n-6) highly unsaturated fatty acid, as measured in fasting plasma as a percent of total fatty acids.

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)6.45± 0.29
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)7.02± 0.22
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)6.21± 0.28
Proportion of n-3 HUFA Eicosapentaenoic Acid (EPA) Secondary · Baseline

Tissue accretion of eicosapentaenoic acid (EPA or 20:5n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)0.434± 0.065
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)0.455± 0.046
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)0.504± 0.062
Proportion of n-3 HUFA Eicosapentaenoic Acid (EPA) Secondary · Week 4

Tissue accretion of eicosapentaenoic acid (EPA or 20:5n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)0.356± 0.061
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)0.479± 0.047
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)0.927± 0.061
Proportion of n-3 HUFA Eicosapentaenoic Acid (EPA) Secondary · Week 8

Tissue accretion of eicosapentaenoic acid (EPA or 20:5n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)0.324± 0.064
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)0.452± 0.051
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)0.806± 0.061
Proportion of n-3 HUFA Eicosapentaenoic Acid (EPA) Secondary · Week 12

Tissue accretion of eicosapentaenoic acid (EPA or 20:5n3), an omega-3 (n-3) highly unsaturated fatty acid (HUFA), as measured in fasting plasma as a percent of total fatty acids.

GroupValue95% CI
Diet A: Low Omega-3 (n-3) + High Linoleic Acid (LA)0.338± 0.061
Diet B: Low Omega-3 (n-3) + Low Linoleic Acid (LA)0.388± 0.048
Diet C: High Omega-3 (n-3) + Low Linoleic Acid (LA)0.707± 0.062

Sponsor's own description

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....

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Lipidomic profiling of targeted oxylipins with ultra-performance liquid chromatography-tandem mass spectrometry.
    Yuan ZX, Majchrzak-Hong S, Keyes GS, Iadarola MJ, et al · · 2018 · cited 54× · PMID 30074088 · DOI 10.1007/s00216-018-1222-4
  2. Quantitation of Human Whole-Body Synthesis-Secretion Rates of Docosahexaenoic Acid and Eicosapentaenoate Acid from Circulating Unesterified α-Linolenic Acid at Steady State.
    Lin YH, Hibbeln JR, Domenichiello AF, Ramsden CE, et al · · 2018 · cited 14× · PMID 30074625 · DOI 10.1002/lipd.12055
  3. Dietary linoleic acid lowering alone does not lower arachidonic acid or endocannabinoids among women with overweight and obesity: A randomized, controlled trial.
    Courville AB, Majchrzak-Hong S, Yang S, Turner S, et al · · 2023 · cited 3× · PMID 38100748 · DOI 10.1002/lipd.12382
  4. Biochemical and behavioral effects of decreasing dietary linoleic acid and increasing eicosapentaenoic acid and docosahexaenoic acid in a rat chronic monoarthrits model.
    Domenichiello AF, Wilhite BC, Nara P, Pitcher MH, et al · · 2022 · cited 2× · PMID 36347090 · DOI 10.1016/j.plefa.2022.102512

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01251887.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing