An Intervention to Develop Interface Tools for Nutrigenomics

Building New Nutrigenomics Technology Interface Tools for Consumers and Health Professionals

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.

Study Overview

• Status: Unknown
• Conditions: Adult
• Intervention / Treatment: Other: Personalized nutrition

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada
      • Innovation Boulevard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults, aged 35-55 years.
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:

1. Currently on a therapeutic or restrictive diet (e.g., Atkins).
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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized nutrition intervention; Participant receives gene-test results plus personalized nutrition information from a registered dietician	Other: Personalized nutrition; Receives individualized nutrition information
Placebo Comparator: Usual nutrigenomics intervention; Participant receives usual nutrigenomics intervention (direct-to-consumer)	Other: Personalized nutrition; Receives individualized nutrition information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet quality	Healthy eating index	8 weeks

Collaborators and Investigators

• Sponsor: Kwantlen Polytechnic University
• Collaborators: Natural Sciences and Engineering Research Council, Canada
• Investigators: Principal Investigator: Karen Davison, PhD, Kwantlen Polytechnic University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Anticipated): November 30, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 500692 - 16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No