NCT03310814

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

August 29, 2017

Last Update Submit

October 10, 2017

Conditions

Adult

Outcome Measures

Primary Outcomes (1)

  • Diet quality

    Healthy eating index

    8 weeks

Study Arms (2)

Personalized nutrition intervention

EXPERIMENTAL

Participant receives gene-test results plus personalized nutrition information from a registered dietician

Other: Personalized nutrition

Usual nutrigenomics intervention

PLACEBO COMPARATOR

Participant receives usual nutrigenomics intervention (direct-to-consumer)

Other: Personalized nutrition

Interventions

Personalized nutritionOTHER

Receives individualized nutrition information

Personalized nutrition interventionUsual nutrigenomics intervention

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults, aged 35-55 years.
  • Ability to understand sign an informed consent and to give a buccal DNA swab.
  • Willing to improve their health.
  • 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).

You may not qualify if:

  • Currently on a therapeutic or restrictive diet (e.g., Atkins).
  • Diagnosis of 2 or more chronic diseases or unstable chronic disease as deemed by accepted clinical guidelines.
  • Clinical diagnosis of any mental health condition.
  • Current or former malignancy for which the participant has undergone resection, radiation therapy or chemotherapy within 5 years prior to baseline.
  • 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.
  • 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.
  • Currently enrolled or plan to be enrolled in another research study during the course of this investigation.
  • Planned or recent (within the last 12 months) bariatric surgery.
  • Current use of weight altering medication for the purpose of weight loss.
  • Uncorrected hypothyroidism or hyperthyroidism in the previous 12 months.
  • Alcohol or drug dependence during the previous 12 months.
  • Investigators and their immediate families. Immediate family was defined as a spouse, parent, child or sibling, whether biological or legally adopted.
  • Pregnant and/or breastfeeding.
  • Current smoker.
  • BMI ≥ 35.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovation Boulevard

Surrey, British Columbia, Canada

Location

Related Publications (2)

  • 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.

    PMID: 31254340DERIVED

  • 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.

    PMID: 29891470DERIVED

Study Officials

  • Karen Davison, PhD

    Kwantlen Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2017

First Posted

October 16, 2017

Study Start

March 15, 2017

Primary Completion

November 30, 2017

Study Completion

December 31, 2017

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

CA(1)