Trial Outcomes & Findings for Personalized Nutrition in Young Adults: The Ability of Genetic Information to Motivate Changes in Omega-3 Consumption (NCT NCT02829138)
NCT ID: NCT02829138
Last Updated: 2018-02-05
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2018-02-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Personalized Nutrition in Young Adults: The Ability of Genetic Information to Motivate Changes in Omega-3 Consumption
Baseline characteristics by cohort
| Measure |
Non-genetic Group
n=29 Participants
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.
|
Genetic Group
n=28 Participants
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.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
29 participants
n=93 Participants
|
28 participants
n=4 Participants
|
57 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline 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).
Outcome measures
| Measure |
Non-genetic Group
n=28 Participants
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.
|
Genetic Group
n=28 Participants
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.
|
|---|---|---|
|
Omega-3 Dietary Intake
Baseline
|
190.16 mg/day
Standard Error 39.21
|
211.50 mg/day
Standard Error 43.16
|
|
Omega-3 Dietary Intake
12 weeks
|
395.82 mg/day
Standard Error 70.60
|
323.23 mg/day
Standard Error 65.27
|
SECONDARY outcome
Timeframe: baseline and 12 weeksTriglycerides were measured in fasted serum. Data is reported as mmol/L
Outcome measures
| Measure |
Non-genetic Group
n=28 Participants
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.
|
Genetic Group
n=28 Participants
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.
|
|---|---|---|
|
Change in Blood Triglycerides (Physiological Parameter)
Baseline
|
1.02 mmol/L
Standard Error 0.07
|
0.9 mmol/L
Standard Error 0.07
|
|
Change in Blood Triglycerides (Physiological Parameter)
12 weeks
|
1.02 mmol/L
Standard Error 0.06
|
1.02 mmol/L
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Non-genetic Group
n=28 Participants
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.
|
Genetic Group
n=28 Participants
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.
|
|---|---|---|
|
Change in Omega-3 Index in Blood (Physiological Parameter)
Baseline
|
3.97 percentage of total fatty acids in serum
Standard Error 0.12
|
3.86 percentage of total fatty acids in serum
Standard Error 0.11
|
|
Change in Omega-3 Index in Blood (Physiological Parameter)
12 weeks
|
4.15 percentage of total fatty acids in serum
Standard Error 0.13
|
3.97 percentage of total fatty acids in serum
Standard Error 0.11
|
Adverse Events
Non-genetic Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genetic Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place