The Optimum Omega-3 (003) Diet Study

March 18, 2019 updated by: Catherine Champagne, Pennington Biomedical Research Center

The Optimum Omega -3 (003) Diet Study

The goal of the Optimum Omega-3 (OO3) Diet Study is to assess whether swapping specific food ingredients in diets can significantly change omega-3 blood profiles with 10 weeks of a 7-day menu in men and women (18-40 years old). We want to look at the effect on a person's response to cognition, satiety and physical fitness. Investigators think that low omega-6 and moderate omega-3 fatty acid diets may regulate emotional response and help to return to normal after load carrying activities. We plan to test the effects of improving overall fatty acids on emotional response, satiety, and physical fitness levels by a diet with an improved omega-3 to omega-6 diet compared to a control diet.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of the Optimum Omega-3 (OO3) Diet Study is to assess whether swapping specific food ingredients in components of US Military Garrison diet can significantly change blood profiles of n-3 HUFAs (highly unsaturated fatty acids) from baseline with 10 weeks of a 7-day menu in men and women (18-40 years old), and its effect on a person's response to cognitive measures, satiety and physical fitness (Adjunct Studies). The Department of Defense is interested in strategies to improve body composition of n-3 HUFAs and whether such strategies help people respond better emotionally. It is felt that low omega-6 and moderate omega-3 fatty acid diets may improve the regulation of emotional responses, and may accelerate return of muscle strength and lower limb range of motion after fatiguing exercise such as walking while carrying a heavy load. We plan to test the effects of improving overall fatty acids on cognitive response, satiety, and physical fitness levels by substituting all chicken meat, eggs, beef, oil and other ingredients in 7 days of 3 meals plus snacks with like products that have low omega-6 PUFA (and/or enhanced omega-3 PUFA) in comparison with a control diet in which the ingredients have not been replaced.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-40 years of age
  • Healthy and able to perform all requirements of the study without injury.
  • Body Mass Index (BMI), >18 and <30 Kg/m2 (BMI is a measure of your height and weight ratio.
  • No history of cardiac problems or evidence of current heart problems.
  • willing to use effective method of birth control if you are capable of bearing children.
  • willing to consume menus for 10 consecutive weeks.
  • willing to complete all study-related activities.
  • If you are taking dietary supplements, you are willing to discontinue their use during the study.
  • willing to follow the alcohol consumption restrictions during the study.
  • Have access to a personal microwave and refrigerator to keep foods at the proper temperature for storage and consumption.

Exclusion Criteria:

  • Have a history of gall stones or any other significant metabolic, blood, lung, neurologic (nervous system), immune, liver, kidney, or urologic (urinary system) disorders.
  • Have any disease or condition that seriously affects body weight and/or body composition.
  • Practice a vegan or vegetarian dietary lifestyle.
  • Are gluten intolerant (allergic reaction to wheat products)
  • Have a history of short-term (less than a month) treatment woth steroids within six months prior to randomization into the 003 Diet Study.
  • Require regular use of medications that ma interfere with the study (other than contraceptives or other medications that have been on a stable dose for 6 months prior to the study). the study staff will review all medication criteria with you.
  • Have diabetes.
  • Have a history or evidence of significant gastrointestinal dysfunction.
  • Chronically use laxatives, The use of stool softeners is acceptable. Use of bulking agents, if required, should remain constant.
  • Have abnormal blood or urine results.
  • Have evidence or recurrence of cancers within the past five years if it is thought to interfere with study participation, other than some skin cancers.
  • Anticipate surgery during the study period.
  • Donated blood during the month prior to study entry or plan to during the study.
  • Have participated in other studies using an investigational drug during the preceding 3 months.
  • Have had a fluctuation in body weight >10% (or about 15 lbs) in the preceding 2 months.
  • Are taking prescription or over the counter medication or supplements for desired weight loss.
  • Are taking prescription or over the counter medication or supplements for desired weight loss.
  • Drink more than 4 alcoholic drinks daily or 6 on one occasion more than once a month within the past 6 months.
  • Currently using cocaine, amphetamines, or other illicit substances.
  • Have a psychiatric disorder that would interfere with your ability to complete the study.
  • Are claustrophobic.
  • Have a history of post-traumatic stress disorder, anxiety or panic attack disorders, or other psychological/fear/or anxiety disorders.
  • Are unwilling or unable to follow the rigors of the data collection and clinical evaluation schedule over the study period.
  • Are pregnant, breast feeding or planning to become pregnant before the end of the study.
  • Are unwilling to be assigned at random to any intervention group.
  • Are participating in another intervention program.
  • Consume seafood more than 3 times per week in a the last 6 months (specifically tuna, salmon, and other types of fatty cold fishes or seafood).
  • Use NSAIDS (asprin, ibuprofen, etc.) more than 2 times per week.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Regular Diet
If you are accepted into the study, you will be randomized into one of 3 treatment arms which only differ according to the foods consumed. All groups will receive smoothies with these diets.
Other: The Optimum Omega-3 Fatty Acid Feeding Study
Assess whether swapping specific food ingredients in the diet can significantly improve polyunsaturated fatty acid blood profiles and improve a person's response to cognitive measures and physical fitness.
Other Names:
  • Omega-3 Fatty Acids
  • Omega-3 to Omega-6 Ratios
  • Physical performance and omega-3
ACTIVE_COMPARATOR: Medium Omega-3 Group
If you are accepted into the study, you will be randomized into one of 3 treatment arms which only differ according to the foods consumed. All groups will receive smoothies with these diets.
Other: The Optimum Omega-3 Fatty Acid Feeding Study
Assess whether swapping specific food ingredients in the diet can significantly improve polyunsaturated fatty acid blood profiles and improve a person's response to cognitive measures and physical fitness.
Other Names:
  • Omega-3 Fatty Acids
  • Omega-3 to Omega-6 Ratios
  • Physical performance and omega-3
ACTIVE_COMPARATOR: High Omega-3 Group
If you are accepted into the study, you will be randomized into one of 3 treatment arms which only differ according to the foods consumed. All groups will receive smoothies with these diets.
Other: The Optimum Omega-3 Fatty Acid Feeding Study
Assess whether swapping specific food ingredients in the diet can significantly improve polyunsaturated fatty acid blood profiles and improve a person's response to cognitive measures and physical fitness.
Other Names:
  • Omega-3 Fatty Acids
  • Omega-3 to Omega-6 Ratios
  • Physical performance and omega-3

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in blood levels of omega-3 fatty acids
Time Frame: After 12 weeks of feeding
We expect to see an increase in blood levels of omega-3 fatty acids in participants following 12 weeks of consuming a diet high in omega-3 fatty acids and a lower content of omega-6 fatty acids for a more positive ratio of omega-3 to omega-6 and related to a variety of positive health outcomes.
After 12 weeks of feeding

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Increased stress resilience and improved physical performance.
Time Frame: After 12 weeks of feeding
We expect to see improved cognitive and emotional measures. In addition, we anticipate improved physical performance in the load carrying and power testing at the end of the trial.
After 12 weeks of feeding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pennington Biomedical Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine M Champagne, PhD,RDN,LDN, Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBRC 11026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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