The Optimum Omega-3 (003) Diet Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Catherine Champagne, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01642368
First received: July 14, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The goal of The OO3 Diet Study is to assess whether swapping specific food ingredients in foods can significantly change omega-3 blood profiles with 12 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 stress, satiety and physical fitness. Investigators think that low omega-6 and moderate omega-3 fatty acid diets may improve the stress response, 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 stress, satiety, and physical fitness levels by a diet with an improved omega-3 to omega-6 diet compared to a control diet.


Condition Intervention
Stress, Physiological
Other: The Optimum Omega-3 Fatty Acid Feeding Study

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Optimum Omega -3 (003) Diet Study

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Change in blood levels of omega-3 fatty acids [ Time Frame: After 12 weeks of feeding ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Increased stress resilience and improved physical performance. [ Time Frame: After 12 weeks of feeding ] [ Designated as safety issue: No ]
    We expect to see improved stress resilience to the endotoxin testing procedure with 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.


Estimated Enrollment: 72
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Access whether swapping specific food ingredients in the diet can significantly improve Polyunsaturated fatty acid blood profiles and improve a person's response to stress and physical fitness.
Other Names:
  • Omega-3 Fatty Acids
  • Omega-3 to Omega-6 Ratios
  • Stress and omega-3
  • Physical performance and omega-3
  • Combat 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
Access whether swapping specific food ingredients in the diet can significantly improve Polyunsaturated fatty acid blood profiles and improve a person's response to stress and physical fitness.
Other Names:
  • Omega-3 Fatty Acids
  • Omega-3 to Omega-6 Ratios
  • Stress and omega-3
  • Physical performance and omega-3
  • Combat 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
Access whether swapping specific food ingredients in the diet can significantly improve Polyunsaturated fatty acid blood profiles and improve a person's response to stress and physical fitness.
Other Names:
  • Omega-3 Fatty Acids
  • Omega-3 to Omega-6 Ratios
  • Stress and omega-3
  • Physical performance and omega-3
  • Combat and omega-3

Detailed Description:

The goal of The 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 12 weeks of a 7-day menu in men and women (18-40 years old), and its effect on a person's response to stress, satiety and physical fitness (Adjunct Studies). The Department of Defense is interested in strategies to improve body compositions of n-3 HUFAs and whether such strategies help people respond better to stress. It is felt that low omega-6 and moderate omega-3 fatty acid diets may improve the stress response, particularly with regard to 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 stress, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 <25 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 12 consecutive weeks.
  • willing to complete all study-realted 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 conditon that seriously affects body weight and/or body conposition.
  • 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 medicaton 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 yuears 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 ome 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642368

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Catherine M Champagne, PhD,RD,LDN Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Catherine Champagne, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01642368     History of Changes
Other Study ID Numbers: PBRC11026
Study First Received: July 14, 2012
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Omega-3 fatty acids
Omega-3 to omega-6 ratio
Stress resilience
Physical performance

ClinicalTrials.gov processed this record on September 14, 2014