NCT03310814

An Intervention to Develop Interface Tools for Nutrigenomics

Building New Nutrigenomics Technology Interface Tools for Consumers and Health Professionals

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Kwantlen Polytechnic University · Academic / Other
• Sex: All
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study compares the efficacy of a non-practitioner assisted direct-to-consumer (DTC) self-driven approach to nutrigenomics versus a personalized practitioner-led method. The secondary aims are to use this data combined with participant feedback to generate more effective nutrigenomics-based products.

Detailed description

While nutrition is a widely accepted tool for the prevention of long-term health conditions, current approaches have not adequately reduced chronic disease morbidity. Nutrigenomics has great potential, however, it is complicated to implement. There is a need for products, derived from nutrigenomics, which are easily understood, accessible and utilized. The primary objective of this study is to compare the efficacy of a non-practitioner assisted direct-to-consumer (DTC) self-driven approach to nutrigenomics versus a personalized practitioner-led method. The secondary aims are to use this data combined with participant feedback to generate more effective nutrigenomics-based products. 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

• Adult

Interventions

Type	Name	Description
OTHER	Personalized nutrition	Receives individualized nutrition information

Timeline

• Start date: 2017-03-15
• Primary completion: 2017-11-30
• Completion: 2017-12-31
• First posted: 2017-10-16
• Last updated: 2017-10-16

Locations

1 site across 1 country: Canada