Neuroimaging, Omega-3 and Reward in Adults With ADHD (NORAA) Trial

NCT02156089 | Terminated Phase 2

• 2 other identifiers: 14012014-AA-0120
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- People with attention-deficit hyperactivity disorder (ADHD) often have problems with motivation and rewards. . Omega-3 fats have helped symptoms of ADHD improve in children. Researchers want to learn more about the brain activity of people with ADHD and see how taking omega-3 fats might help. Objective: \- To learn more about how omega-3 fats affect brain activity and ADHD symptoms. Eligibility: \- Adults age 18 55 with ADHD symptoms. Design:

• Participants will be screened with medical history and review of medical records.
• For study visit 1, participants will have a medical examination and be interviewed to confirm they have ADHD. They will have an IQ test and give blood and urine samples. Height, weight, and blood pressure will be measured. They will also need to sign consent to agree to take part in the study. They will be asked to complete a food diary for 4 days
• For visit 2, participants will give a blood sample. They will complete questionnaires about their mood and ADHD symptoms.. They may give a blood or saliva sample for genetic testing.
• Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table that slides in and out of a metal cylinder. It makes loud noises; participants will get earplugs. This scan examines the structure of the brain.
• Participants will have a functional MRI scan. This scan measures the function of the brain while the volunteer is performing tasks in the scanner. They will stop ADHD medications 48 hours before this scan.
• Participants will receive key-lime flavored omega-3 smoothie mix or placebo to takeevery day
• For visit 3, participants will give blood samples and complete questionnaires.
• For visit 4, participants will be weighed and have a blood test and MRI scans as per before. They will repeat the questionnaires and will guess whether they received the omega-3 or placebo.

Conditions

Attention Deficit Disorder; Attention Deficit Hyerpactivity Disorder

Keywords

fMRI; Reward Processing; Nutrition; Omega-3 Fatty Acids; ADHD

Outcome Measures

Primary Outcomes (1)

• To test if omega-3 HUFA intervention results in greater ventral-striatal activation during a reward task in adults with ADHD compared to a placebo group between baseline and follow up at 16 weeks.

  baseline and afte 15 weeks

Interventions

Highly unsaturated omega-3 fatty acids OTHER

Nitrient - Matched Placebo of 3 g/d of macademia nut oil (in comparison to 3 g/d of omega-3 highly unsaturated fatty acids).

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will be 18 or over and up to 55 years old.
• In general good health.
• Body Mass Index (BMI) between 18 and 35.
• Able to come to the NIH clinical center for each of their scheduled appointments for the duration of the study and have a working phone number.
• Able to understand the consent form and provide written informed consent.
• Have an IQ of 70 or greater as assessed by the WASI for fast IQ testing (a score of less than this is considered to have global intellectual disability - classified in DSM-IV as mental retardation). There are often issues around the ability to give informed consent in adults with global intellectual disability.
• Meet DSM diagnostic criteria for ADHD as assessed by the CAADID Conners Adult ADHD Diagnostic Interview for DSM-IV.
• Have significant symptoms of ADHD despite concurrent pharmacological and psychological therapies as assessed by the Connors Adult ADHD rating scale (CAARS) (as assessed at telephone screen).
• Be willing to have a 48hour wash-out of stimulant medication prior to both baseline and follow-up scans.
• Willing to stop all nutritional supplements including omega-3 fats.
• Willing to stop eating seafood for the study duration of 16 weeks.
• Be willing to have 2 MRI scanning sessions.
• People who are willing to take the smoothie emulsion every day for 16 weeks.

You may not qualify if:

• Any medical illness or treatment that in the view of the investigators would compromise participation in research or participant safety, as determined by medical history, physical examination, laboratory tests (see details under Screening measures below), including, but not limited to:
• Unstable medical conditions requiring immediate intervention.
• Unstable or rapidly progressive neurological diseases.
• History hemorrhagic or ischemic stroke within the last 3 months.
• Known heart disease.
• Hypertension.
• Asthma
• If the participant is related to the study investigator or their superior, subordinate, or immediate family member.
• HIV positive.
• Significant dietary limitations:
• Allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats which are found in fish..
• Allergy, hypersensitivity, or intolerance to Macadamia nuts or any nuts such as almonds, walnuts, pecans, peanuts, etc.
• Pregnancy or breastfeeding (by urine pregnancy test; self-report).
• Reported consumption of fish and seafood three or more times per week within the last three months.
• Regular consumption of omega-3 supplements (e.g., cod liver oil, borage oil, fish oil or evening primrose oil) , defined as an average of 250 mg/day of omega-3 HUFAs over the previous 3 months.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bondi CO, Taha AY, Tock JL, Totah NK, Cheon Y, Torres GE, Rapoport SI, Moghaddam B. Adolescent behavior and dopamine availability are uniquely sensitive to dietary omega-3 fatty acid deficiency. Biol Psychiatry. 2014 Jan 1;75(1):38-46. doi: 10.1016/j.biopsych.2013.06.007. Epub 2013 Jul 25.

  PMID: 23890734 BACKGROUND

• Zimmer L, Delion-Vancassel S, Durand G, Guilloteau D, Bodard S, Besnard JC, Chalon S. Modification of dopamine neurotransmission in the nucleus accumbens of rats deficient in n-3 polyunsaturated fatty acids. J Lipid Res. 2000 Jan;41(1):32-40.

  PMID: 10627499 BACKGROUND

• Zimmer L, Delpal S, Guilloteau D, Aioun J, Durand G, Chalon S. Chronic n-3 polyunsaturated fatty acid deficiency alters dopamine vesicle density in the rat frontal cortex. Neurosci Lett. 2000 Apr 21;284(1-2):25-8. doi: 10.1016/s0304-3940(00)00950-2.

  PMID: 10771153 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Joseph R Hibbeln, M.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 5, 2014
• Study Start: June 4, 2014
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12-21

Locations

US (1)