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

• ClinicalTrials.gov Identifier: NCT02829138
• Recruitment Status: Completed
• First Posted: July 12, 2016
• Results First Posted: January 9, 2018
• Last Update Posted: February 5, 2018
• Sponsor: University of Guelph
• Information provided by (Responsible Party): David M Mutch, University of Guelph

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Health Behaviour; Nutrition Intervention; Impaired Health	Genetic: Genetic information and Omega-3 fat intake; Behavioral: General Nutrition related to Omega-3 fats	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Personalized Nutrition in Young Adults: The Ability of Genetic Information to Motivate Changes in Omega-3 Consumption
• Study Start Date: August 2015
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: March 2016

Arms and Interventions

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.	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.; Behavioral: General Nutrition related to Omega-3 fats; Both the Genetic and Non-Genetic groups will receive general nutrition information about omega-3 fats.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Change in Blood Triglycerides (Physiological Parameter) [ Time Frame: baseline and 12 weeks ]
   Triglycerides were measured in fasted serum. Data is reported as mmol/L
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 25 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of Guelph

Investigators

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

More Information

Publications of Results:

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). pii: E240. doi: 10.3390/nu9030240.

Other Publications:

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. Review.

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. Erratum in: BMJ. 2015;350:h1702.

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.

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.

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. Review.

• Responsible Party: David M Mutch, Dr. David Mutch, PhD, University of Guelph
• ClinicalTrials.gov Identifier: NCT02829138
• Other Study ID Numbers: Personalized Nutrition
• First Posted: July 12, 2016
• Results First Posted: January 9, 2018
• Last Update Posted: February 5, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No