Clinical trial NCT02829138: Personalized Nutrition in Young Adults: The Ability of Genetic Information to Motivate Changes in Omega-3 Consumption
Official title: Personalized Nutrition in Young Adults: The Ability of Genetic Information to Motivate Changes in Omega-3 Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behaviour
Nutrition Intervention
Impaired Health
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Omega-3 Dietary Intake
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Blood Triglycerides (Physiological Parameter)
timeFrame: baseline and 12 weeks
measure: Change in Omega-3 Index in Blood (Physiological Parameter)
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Guelph
name: David M Mutch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.