Personalized Nutrition in Young Adults: The Ability of Genetic Information to Motivate Changes in Omega-3 Consumption

January 8, 2018 updated by: David M Mutch, University of Guelph

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 numerous health benefits associated with omega-3 fats are well documented in scientific literature; however, there are a limited number of studies focused on the health effects of omega-3 fats in emerging adults (18-25 years). Indeed, most research to date has been conducted in older adults, with or without hyperlipidemia. In addition, it is important to consider interventions in emerging adults given that behaviours learned in this life stage can persist later in life. It has also been reported that the diet quality (i.e., amount of fruits, vegetables, whole grains, etc.) is reduced for individuals within this age range; thus highlighting another important reason for targeting this demographic.

The combination of genetic and dietary information (i.e., nutrigenetics) has the potential to not only benefit basic research, but also the general population. Therefore, more research is needed to determine if providing individuals with their genetic information has the potential to encourage behaviour changes. So far, several studies have investigated how people may change their behaviour in response to genetic risk information, but none have conducted a nutrigenetic intervention examining if providing personal genetic information alters diet behaviours.

The overall objective of this study is to examine whether providing emerging adults with personal genetic information changes their behavior with regards to omega-3 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 personal information for 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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between the ages of 18-25 years

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Non-genetic Group
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
Both the Genetic and Non-Genetic groups will receive general nutrition information about omega-3 fats.
Experimental: Genetic Group
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.
Behavioral: General Nutrition related to Omega-3 fats
Both the Genetic and Non-Genetic groups will receive general nutrition information about omega-3 fats.
Genetic: Genetic information and Omega-3 fat intake
Only the Genetic group will receive their personal genetic information prior to beginning the 3-month study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Omega-3 Dietary Intake
Time Frame: Baseline and 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Triglycerides (Physiological Parameter)
Time Frame: baseline and 12 weeks
Triglycerides were measured in fasted serum. Data is reported as mmol/L
baseline and 12 weeks
Change in Omega-3 Index in Blood (Physiological Parameter)
Time Frame: baseline and 12 weeks
Blood fatty acids measured by gas chromatography. Data is reported as a percentage of all detected fatty acids. The omega-3 index is calculated by summing data for 3 omega-3 fats in serum: ALA, EPA, and DHA.
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guelph

Investigators

  • Principal Investigator: David M Mutch, PhD, University of Guelph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Personalized Nutrition

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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