The Optimum Omega-3 (003) Diet Study



Status:Completed
Healthy:No
Age Range:18 - 40
Updated:3/22/2019
Start Date:June 2012
End Date:November 2013

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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.

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.

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.
We found this trial at
1
site
6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
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