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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02829138
Other study ID # Personalized Nutrition
Secondary ID
Status Completed
Phase N/A
First received July 6, 2016
Last updated January 8, 2018
Start date August 2015
Est. completion date March 2016

Study information

Verified date January 2018
Source University of Guelph
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Guelph

References & Publications (6)

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. — View 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. Review. — View 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. Erratum in: BMJ. 2015;350:h1702. — View 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). pii: E240. doi: — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in Blood Triglycerides (Physiological Parameter) Triglycerides were measured in fasted serum. Data is reported as mmol/L baseline and 12 weeks
Secondary Change in Omega-3 Index in Blood (Physiological Parameter) 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
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