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

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ClinicalTrials.gov Identifier: NCT02829138
Recruitment Status : Completed
First Posted : July 12, 2016
Results First Posted : January 9, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
David M Mutch, University of Guelph

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Health Behaviour
Nutrition Intervention
Impaired Health
Interventions Genetic: Genetic information and Omega-3 fat intake
Behavioral: General Nutrition related to Omega-3 fats
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-genetic Group Genetic Group
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 29 28
Completed 28 28
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Non-genetic Group Genetic Group Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 29 28 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
28
 100.0%
57
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 57 participants
Female
29
 100.0%
28
 100.0%
57
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 29 participants 28 participants 57 participants
29 28 57
1.Primary Outcome
Title Omega-3 Dietary Intake
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-genetic Group Genetic Group
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mg/day
Baseline 190.16  (39.21) 211.50  (43.16)
12 weeks 395.82  (70.60) 323.23  (65.27)
2.Secondary Outcome
Title Change in Blood Triglycerides (Physiological Parameter)
Hide Description Triglycerides were measured in fasted serum. Data is reported as mmol/L
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-genetic Group Genetic Group
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mmol/L
Baseline 1.02  (0.07) 0.9  (0.07)
12 weeks 1.02  (0.06) 1.02  (0.08)
3.Secondary Outcome
Title Change in Omega-3 Index in Blood (Physiological Parameter)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-genetic Group Genetic Group
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: percentage of total fatty acids in serum
Baseline 3.97  (0.12) 3.86  (0.11)
12 weeks 4.15  (0.13) 3.97  (0.11)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-genetic Group Genetic Group
Hide Arm/Group Description 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 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.
All-Cause Mortality
Non-genetic Group Genetic Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Non-genetic Group Genetic Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-genetic Group Genetic Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. David M Mutch
Organization: University of Guelph
Phone: +1-519-824-4120 ext 53322
Responsible Party: David M Mutch, University of Guelph
ClinicalTrials.gov Identifier: NCT02829138     History of Changes
Other Study ID Numbers: Personalized Nutrition
First Submitted: July 6, 2016
First Posted: July 12, 2016
Results First Submitted: December 11, 2017
Results First Posted: January 9, 2018
Last Update Posted: February 2, 2018