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NCT01251887 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Completed
Registry status
NA
Development phase
85
Enrollment target

NCT01251887: Completed NA study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

NCT01251887 is a NA study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 85 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01251887, a NA study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

COMPLETED
Registry status
NA
Development phase
85 participants
Enrollment target

Study 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 assig

Primary Outcome

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

Interventions

  • DIETARY_SUPPLEMENT Docosahexaenoic Acid
  • DIETARY_SUPPLEMENT Linoleic Acid
  • DIETARY_SUPPLEMENT Eicosapentaenoic Acid

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2010-11-12
Est. Completion 2018-07-25
Phase NA

What the finished NCT01251887 record still lists

NCT01251887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 3 interventions - of which Docosahexaenoic Acid is the first listed.

NCT01251887 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01251887 about?

NCT01251887 is a clinical study titled "Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition". 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 aff...

What is the current status of trial NCT01251887?

This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2010-11-12. Estimated completion is 2018-07-25.

What interventions are being tested in trial NCT01251887?

The interventions under investigation include: Docosahexaenoic Acid (DIETARY_SUPPLEMENT), Linoleic Acid (DIETARY_SUPPLEMENT), Eicosapentaenoic Acid (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01251887?

This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01251887's enrollment target sits among peer trials

85 980th of 2000 higher than 1,018 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01251887, the US trial registry maintained by the National Library of Medicine. NCT01251887 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.