An Intervention to Develop Interface Tools for Nutrigenomics
NCT ID: NCT03310814
Last Updated: 2017-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
57 participants
INTERVENTIONAL
2017-03-15
2017-12-31
Brief Summary
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Detailed Description
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Methods:
This 4-month study used a mixed-methods design that included: 1) a phase 1 randomized control trial that examined the effectiveness of a multi-faceted, nutrition-based gene test (components assessed included the major nutrients, food tolerances, food taste and preferences, and vitamins) in changing health behaviours; followed by 2) qualitative investigation that explored participants' experiences. The study recruited 57 healthy males and females (35-55 years) randomized as a 2:1 ratio where 38 received the intervention (gene-test results plus personalized nutrition report) and 19 were assigned to the control group (gene-test results report emailed). Both groups received follow-up emails with nutrition-related tips and reminders. The primary outcomes of interest measures included changes in diet (nutrients, healthy eating index), self-efficacy, quality of life and anthropometrics (BMI, waist:hip) measured at baseline, post-intervention (3 and 6 weeks), and the final visit. After the study has been completed, participants in the control group will also receive their personalized nutrition report.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Personalized nutrition intervention
Participant receives gene-test results plus personalized nutrition information from a registered dietician
Personalized nutrition
Receives individualized nutrition information
Usual nutrigenomics intervention
Participant receives usual nutrigenomics intervention (direct-to-consumer)
Personalized nutrition
Receives individualized nutrition information
Interventions
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Personalized nutrition
Receives individualized nutrition information
Eligibility Criteria
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Inclusion Criteria
2. Ability to understand sign an informed consent and to give a buccal DNA swab.
3. Willing to improve their health.
4. Medically stable. Subjects diagnosed with diet-related chronic disease were able to enroll in the study, provided that their condition was stabilized or well controlled for at least six months at the time of the baseline visit. Determination of stabilized medical condition was based on established clinical guidelines (e.g., Canadian Diabetes Association Clinical Guidelines and Canadian Cardiovascular Society Guidelines).
Exclusion Criteria
2. Diagnosis of 2 or more chronic diseases or unstable chronic disease as deemed by accepted clinical guidelines.
3. Clinical diagnosis of any mental health condition.
4. Current or former malignancy for which the participant has undergone resection, radiation therapy or chemotherapy within 5 years prior to baseline.
5. Diagnosis of any medical condition or disease, which in the opinion of the Principal Investigator (PI), may have either put the participant at risk, or influenced the results of the study or the participant's ability to participate in the study.
6. Diagnosis of any of the following medical conditions: HIV, COPD, severe/uncontrolled asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, chronic renal failure, colon or small intestine problem, liver or kidney disease.
7. Currently enrolled or plan to be enrolled in another research study during the course of this investigation.
8. Planned or recent (within the last 12 months) bariatric surgery.
9. Current use of weight altering medication for the purpose of weight loss.
10. Uncorrected hypothyroidism or hyperthyroidism in the previous 12 months.
11. Alcohol or drug dependence during the previous 12 months.
12. Investigators and their immediate families. Immediate family was defined as a spouse, parent, child or sibling, whether biological or legally adopted.
13. Pregnant and/or breastfeeding.
14. Current smoker.
15. BMI ≥ 35.
16. Any other health risk that may have impaired the study's ability to assess the impact of nutrigenomic information to improve diet and health.
\-
35 Years
55 Years
ALL
Yes
Sponsors
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Natural Sciences and Engineering Research Council, Canada
OTHER
Kwantlen Polytechnic University
OTHER
Responsible Party
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Karen Davison
Principal Investigator
Principal Investigators
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Karen Davison, PhD
Role: PRINCIPAL_INVESTIGATOR
Kwantlen Polytechnic University
Locations
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Innovation Boulevard
Surrey, British Columbia, Canada
Countries
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References
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Araujo Almeida V, Littlejohn P, Cop I, Brown E, Afroze R, Davison KM. Comparison of Nutrigenomics Technology Interface Tools for Consumers and Health Professionals: A Sequential Explanatory Mixed Methods Investigation. J Med Internet Res. 2019 Jun 28;21(6):e12580. doi: 10.2196/12580.
Littlejohn P, Cop I, Brown E, Afroze R, Davison KM. Comparison of Nutrigenomics Technology Interface Tools for Consumers and Health Professionals: Protocol for a Mixed-Methods Study. JMIR Res Protoc. 2018 Jun 11;7(6):e115. doi: 10.2196/resprot.9846.
Other Identifiers
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500692 - 16
Identifier Type: -
Identifier Source: org_study_id