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Trial record 10 of 34 for:    alpha | linolenic acid

Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans

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ClinicalTrials.gov Identifier: NCT01634776
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Carol Cheatham, PhD, University of North Carolina, Chapel Hill

Brief Summary:
Fatty acids or omega-3s are important in the human diet for brain development. Of the three main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3; docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been shown to be important in brain function. Conversely, little is known about the effects of ALA even though the body can make DHA and EPA from it. Because the rate at which ALA makes DHA and EPA is very slow, ALA is not considered an important source of DHA and EPA. However, in the human diet, ALA is more readily available, more easily consumed, and less expensive relative to animal sources of DHA and EPA. So, it is very important that the investigators explore the effects of supplementation with ALA. It is possible that the ALA to DHA and EPA conversion rate can be altered by methylation, an epigenetic form of gene expression and regulation. In the present study, the investigators will examine memory abilities and genetic baselines in 16-month-olds. The investigators will then supplement their food with ALA or control oil for 4 months. At 20 months, the investigators will collect outcome data on memory, fatty acid status, genetic variations, and methylation. The investigators hypothesize that the ALA supplementation will result in an increase in the rate of ALA to DHA and EPA conversion through methylation and genetic variations and subsequently, memory abilities will improve. The data from this study will be used to design a larger R01 grant.

Condition or disease Intervention/treatment Phase
Effect of Fatty Acids on Memory Performance of Toddlers Dietary Supplement: Flaxseed oil Dietary Supplement: corn oil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans.
Study Start Date : February 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Corn oil
1288 mg/day corn oil
Dietary Supplement: corn oil
Experimental: Flaxseed oil
1200 mg/day flaxseed oil
Dietary Supplement: Flaxseed oil
Families will be asked to mix the contents of one capsule (1200 mg flaxseed oil or 1288 mg corn oil) into a cup of participants' food, twice a day.




Primary Outcome Measures :
  1. Change in declarative memory performance [ Time Frame: Baseline, 120 days ]

Secondary Outcome Measures :
  1. Change in fatty acid levels in plasma [ Time Frame: Baseline, 120 days ]
  2. Stability of methylation of promoter region of FADS2 gene [ Time Frame: Baseline, 120 days ]


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Ages Eligible for Study:   16 Months to 16 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 16-month-old toddlers and their natural mothers
  • Born fullterm and healthy with no complications
  • English as first language

Exclusion Criteria:

  • Any toddler with a documented neurological or blood disorder will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634776


Locations
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United States, North Carolina
UNC at Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Carol L Cheatham, Ph.D. University of North Carolina, Chapel Hill
Principal Investigator: Mihai D Niculescu, M.D., Ph.D. University of North Carolina, Chapel Hill