The Optimum Omega-3 (003) Diet Study

NCT01642368 | Completed

• 1 other identifier: PBRC 11026
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Stress, Physiological

Keywords

Omega-3 fatty acids; Omega-3 to omega-6 ratio; Cognitive response; Physical performance

Outcome Measures

Primary Outcomes (1)

• 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.

  After 12 weeks of feeding

Secondary Outcomes (1)

• Increased stress resilience and improved physical performance.

  After 12 weeks of feeding

Study Arms (3)

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.

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.

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.

Other: The Optimum Omega-3 Fatty Acid Feeding Study

Interventions

The Optimum Omega-3 Fatty Acid Feeding Study OTHER

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.

Also known as: Omega-3 Fatty Acids, Omega-3 to Omega-6 Ratios, Physical performance and omega-3

High Omega-3 Group; Medium Omega-3 Group; Regular Diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Interventions

Fatty Acids, Omega-3; Physical Functional Performance; Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Physical Fitness; Health; Population Characteristics

Study Officials

• Catherine M Champagne, PhD,RDN,LDN

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2012
• First Posted: July 17, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

US (1)