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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02829138
Enrollment
57
Registered
2016-07-12
Start date
2015-08-31
Completion date
2016-03-31
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behaviour, Impaired Health, Nutrition Intervention

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.

Interventions

GENETICGenetic information and Omega-3 fat intake

Only the Genetic group will receive their personal genetic information prior to beginning the 3-month study.

BEHAVIORALGeneral Nutrition related to Omega-3 fats

Both the Genetic and Non-Genetic groups will receive general nutrition information about omega-3 fats.

Sponsors

University of Guelph
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Omega-3 Dietary IntakeBaseline and 12 weeksOmega-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

MeasureTime frameDescription
Change in Blood Triglycerides (Physiological Parameter)baseline and 12 weeksTriglycerides were measured in fasted serum. Data is reported as mmol/L
Change in Omega-3 Index in Blood (Physiological Parameter)baseline and 12 weeksBlood 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.

Participant flow

Participants by arm

ArmCount
Non-genetic Group
General Nutrition related to Omega-3 fats: Individuals in this group were provided with only general nutrition information related to omega-3 fats and health.
29
Genetic Group
Genetic information and Omega-3 fat intake: Individuals in this group were provided with general nutrition information related to omega-3 fats and health, as well as information regarding the impact of a common variant in the FADS1 gene and how this variant influences omega-3 fatty acid profiles.
28
Total57

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicNon-genetic GroupGenetic GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
29 Participants28 Participants57 Participants
Region of Enrollment
Canada
29 participants28 participants57 participants
Sex: Female, Male
Female
29 Participants28 Participants57 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 28
other
Total, other adverse events
0 / 280 / 28
serious
Total, serious adverse events
0 / 280 / 28

Outcome results

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).

Time frame: Baseline and 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Non-genetic GroupOmega-3 Dietary IntakeBaseline190.16 mg/dayStandard Error 39.21
Non-genetic GroupOmega-3 Dietary Intake12 weeks395.82 mg/dayStandard Error 70.6
Genetic GroupOmega-3 Dietary IntakeBaseline211.50 mg/dayStandard Error 43.16
Genetic GroupOmega-3 Dietary Intake12 weeks323.23 mg/dayStandard Error 65.27
Secondary

Change in Blood Triglycerides (Physiological Parameter)

Triglycerides were measured in fasted serum. Data is reported as mmol/L

Time frame: baseline and 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Non-genetic GroupChange in Blood Triglycerides (Physiological Parameter)Baseline1.02 mmol/LStandard Error 0.07
Non-genetic GroupChange in Blood Triglycerides (Physiological Parameter)12 weeks1.02 mmol/LStandard Error 0.06
Genetic GroupChange in Blood Triglycerides (Physiological Parameter)Baseline0.9 mmol/LStandard Error 0.07
Genetic GroupChange in Blood Triglycerides (Physiological Parameter)12 weeks1.02 mmol/LStandard Error 0.08
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.

Time frame: baseline and 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Non-genetic GroupChange in Omega-3 Index in Blood (Physiological Parameter)Baseline3.97 percentage of total fatty acids in serumStandard Error 0.12
Non-genetic GroupChange in Omega-3 Index in Blood (Physiological Parameter)12 weeks4.15 percentage of total fatty acids in serumStandard Error 0.13
Genetic GroupChange in Omega-3 Index in Blood (Physiological Parameter)Baseline3.86 percentage of total fatty acids in serumStandard Error 0.11
Genetic GroupChange in Omega-3 Index in Blood (Physiological Parameter)12 weeks3.97 percentage of total fatty acids in serumStandard Error 0.11

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026