NCT02829138

Brief Summary

There are many health benefits associated with the consumption of omega-3 dietary fats. Omega-3 fats, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), can be found in marine food products such as fatty fish, in fortified products such as eggs and milk, or in dietary supplements such as fish oil. Despite numerous health benefits, it is well documented that most people in Western society are not meeting the recommended daily amounts of EPA and DHA omega-3 fats. The overall objective of this study is to examine whether providing young adults (18-25 years) with personal genetic information changes behavior with regards to omega-3 fat consumption. In order to achieve this objective, study participants will be divided into two groups: 1. Genetic and 2. Non-Genetic. The Genetic Group will be provided with their personalized information regarding a common gene variant in addition to general information regarding the health benefits of omega-3 fats, while the Non-Genetic Group will only receive the general information. Primary outcomes studied will include dietary habits and secondary outcomes include blood markers of cardiometabolic health.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 9, 2018

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

July 6, 2016

Results QC Date

December 11, 2017

Last Update Submit

January 8, 2018

Conditions

Health BehaviourNutrition InterventionImpaired Health

Outcome Measures

Primary Outcomes (1)

  • Omega-3 Dietary Intake

    Omega-3 fat intake was assessed using food frequency questionnaires. The Canadian Nutrient File (version 2015) was used to assess the amount of EPA and DHA in whole foods (e.g., fish, eggs, poultry). Data corresponds to EPA + DHA (mg /day).

    Baseline and 12 weeks

Secondary Outcomes (2)

  • Change in Blood Triglycerides (Physiological Parameter)

    baseline and 12 weeks

  • Change in Omega-3 Index in Blood (Physiological Parameter)

    baseline and 12 weeks

Study Arms (2)

Non-genetic Group

PLACEBO COMPARATOR

General Nutrition related to Omega-3 fats: Individuals in this group will be provided with only general nutrition information related to omega-3 fats and health.

Behavioral: General Nutrition related to Omega-3 fats

Genetic Group

EXPERIMENTAL

Genetic information and Omega-3 fat intake: Individuals in this group will be provided with general nutrition information related to omega-3 fats and health, as well as their personal genetic information for a common gene variant related to omega-3 fatty acid metabolism.

Genetic: Genetic information and Omega-3 fat intakeBehavioral: General Nutrition related to Omega-3 fats

Interventions

Genetic information and Omega-3 fat intakeGENETIC

Only the Genetic group will receive their personal genetic information prior to beginning the 3-month study.

Genetic Group
General Nutrition related to Omega-3 fatsBEHAVIORAL

Both the Genetic and Non-Genetic groups will receive general nutrition information about omega-3 fats.

Genetic GroupNon-genetic Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-25 years

You may not qualify if:

  • Younger than 18 years
  • Older than 25 years
  • Allergic to fish and/or shellfish
  • If the participants are currently consuming high amounts of omega-3 food products
  • Unable to get to the University of Guelph for study visits (lack of transportation, or lives too far away)
  • Anticipating a significant change in lifestyle (moving houses, joining the gym, participating in elite athletic activities)
  • Not comfortable giving blood samples
  • Taking medication which modifies or changes blood lipid levels
  • Expecting to become pregnant, pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Tur JA, Bibiloni MM, Sureda A, Pons A. Dietary sources of omega 3 fatty acids: public health risks and benefits. Br J Nutr. 2012 Jun;107 Suppl 2:S23-52. doi: 10.1017/S0007114512001456.

    PMID: 22591897BACKGROUND

  • Micha R, Khatibzadeh S, Shi P, Fahimi S, Lim S, Andrews KG, Engell RE, Powles J, Ezzati M, Mozaffarian D; Global Burden of Diseases Nutrition and Chronic Diseases Expert Group NutriCoDE. Global, regional, and national consumption levels of dietary fats and oils in 1990 and 2010: a systematic analysis including 266 country-specific nutrition surveys. BMJ. 2014 Apr 15;348:g2272. doi: 10.1136/bmj.g2272.

    PMID: 24736206BACKGROUND

  • Beasley LJ, Hackett AF, Maxwell SM. The dietary and health behaviour of young people aged 18-25 years living independently or in the family home in Liverpool, UK. International Journal of Consumer Studies 28(4): 355-363, 2004.

    BACKGROUND

  • Demory-Luce D, Morales M, Nicklas T, Baranowski T, Zakeri I, Berenson G. Changes in food group consumption patterns from childhood to young adulthood: the Bogalusa Heart Study. J Am Diet Assoc. 2004 Nov;104(11):1684-91. doi: 10.1016/j.jada.2004.07.026.

    PMID: 15499355BACKGROUND

  • McBride CM, Koehly LM, Sanderson SC, Kaphingst KA. The behavioral response to personalized genetic information: will genetic risk profiles motivate individuals and families to choose more healthful behaviors? Annu Rev Public Health. 2010;31:89-103. doi: 10.1146/annurev.publhealth.012809.103532.

    PMID: 20070198BACKGROUND

  • Roke K, Walton K, Klingel SL, Harnett A, Subedi S, Haines J, Mutch DM. Evaluating Changes in Omega-3 Fatty Acid Intake after Receiving Personal FADS1 Genetic Information: A Randomized Nutrigenetic Intervention. Nutrients. 2017 Mar 6;9(3):240. doi: 10.3390/nu9030240.

    PMID: 28272299RESULT

Results Point of Contact

Title
Dr. David M Mutch
Organization
University of Guelph
dmutch@uoguelph.ca
+1-519-824-4120

Study Officials

  • David M Mutch, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. David Mutch, PhD

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 12, 2016

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 5, 2018

Results First Posted

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share