An interventional study of Genetic information and Omega-3 fat intake and General Nutrition related to Omega-3 fats in Health Behaviour, Nutrition Intervention and Impaired Health, sponsored by University of Guelph. Completed. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by University of Guelph · Not applicable, Interventional, and Basic science
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.
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.
University of Guelph is the lead sponsor of 69 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 · Behavioral: General Nutrition related to Omega-3 fats
Only the Genetic group will receive their personal genetic information prior to beginning the 3-month study.
Both the Genetic and Non-Genetic groups will receive general nutrition information about omega-3 fats.
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).
Time frame: Baseline and 12 weeks
Change in Blood Triglycerides (Physiological Parameter)
Triglycerides were measured in fasted serum. Data is reported as mmol/L
Time frame: baseline and 12 weeks
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.
Time frame: baseline and 12 weeks
| Milestone | Non-genetic Group | Genetic Group |
|---|---|---|
| Started | 29 | 28 |
| Completed | 28 | 28 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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).
| mg/day | Non-genetic Group | Genetic Group |
|---|---|---|
| Baseline | 190.16 ± 39.21 | 211.50 ± 43.16 |
| 12 weeks | 395.82 ± 70.60 | 323.23 ± 65.27 |
Triglycerides were measured in fasted serum. Data is reported as mmol/L
| mmol/L | Non-genetic Group | Genetic Group |
|---|---|---|
| Baseline | 1.02 ± 0.07 | 0.9 ± 0.07 |
| 12 weeks | 1.02 ± 0.06 | 1.02 ± 0.08 |
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.
| percentage of total fatty acids in serum | Non-genetic Group | Genetic Group |
|---|---|---|
| Baseline | 3.97 ± 0.12 | 3.86 ± 0.11 |
| 12 weeks | 4.15 ± 0.13 | 3.97 ± 0.11 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-genetic Group | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Genetic Group | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Categorical(Participants) | Non-genetic Group | Genetic Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 28 | 57 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Non-genetic Group | Genetic Group | Total |
|---|---|---|---|
| Female | 29 | 28 | 57 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Non-genetic Group | Genetic Group | Total |
|---|---|---|---|
| Canada | 29 | 28 | 57 |
No study locations are listed for this record.
Plan to share: No
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University of Guelph