Stress, PhysiologicalNCT01642368
The Optimum Omega-3 (003) Diet Study
A study testing The Optimum Omega-3 Fatty Acid Feeding Study in people with Stress, Physiological, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological
- What is being tested?
- The Optimum Omega-3 Fatty Acid Feeding Study
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Physiological
- Being tested
- The Optimum Omega-3 Fatty Acid Feeding Study
- Keywords
- Omega-3 fatty acids, Omega-3 to omega-6 ratio, Cognitive response, Physical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Optimum Omega-3 Fatty Acid Feeding StudyOther
Also called Omega-3 Fatty Acids, Omega-3 to Omega-6 Ratios, Physical performance and omega-3
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.
| Study group | Role | What they receive |
|---|---|---|
| Regular Diet | Placebo comparator | 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. Receives: Other: The Optimum Omega-3 Fatty Acid Feeding Study |
| Medium Omega-3 Group | Active comparator | 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. Receives: Other: The Optimum Omega-3 Fatty Acid Feeding Study |
| High Omega-3 Group | Active comparator | 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. Receives: Other: The Optimum Omega-3 Fatty Acid Feeding Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood levels of omega-3 fatty acids
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.
Measured: After 12 weeks of feeding
Secondary outcomes (1)
Increased stress resilience and improved physical performance.
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.
Measured: After 12 weeks of feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Champagne, Pennington Biomedical Research Center
- Investigators
- Catherine M Champagne, PhD,RDN,LDN, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642368
- Sponsor's protocol ID
- PBRC 11026
- Status last verified
- Mar 2019
- First submitted
- 14 Jul 2012
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimum Omega -3 (003) Diet Study
- ClinicalTrials.gov ID
- NCT01642368
- Acronym / sponsor ID
- PBRC 11026
- Conditions
- Stress, Physiological
- Keywords
- Omega-3 fatty acids, Omega-3 to omega-6 ratio, Cognitive response, Physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular Diet | Placebo comparator | Other: The Optimum Omega-3 Fatty Acid Feeding StudyIf 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. |
| Medium Omega-3 Group | Active comparator | Other: The Optimum Omega-3 Fatty Acid Feeding StudyIf 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. |
| High Omega-3 Group | Active comparator | Other: The Optimum Omega-3 Fatty Acid Feeding StudyIf 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Optimum Omega-3 Fatty Acid Feeding StudyAlso: Omega-3 Fatty Acids, Omega-3 to Omega-6 Ratios, Physical performance and omega-3Assess 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 | High Omega-3 Group, Medium Omega-3 Group, Regular Diet |
Primary outcome
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.
1 secondary outcome
Increased stress resilience and improved physical performance.
Time frame: After 12 weeks of feeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine M Champagne, PhD,RDN,LDN principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Optimum Omega-3 Fatty Acid Feeding Study in people with Stress, Physiological, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood levels of omega-3 fatty acids (time frame: After 12 weeks of feeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.