AdultNCT03310814
An Intervention to Develop Interface Tools for Nutrigenomics
A study testing Personalized nutrition in people with Adult, run by Kwantlen Polytechnic University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult
- What is being tested?
- Personalized nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- Any other health risk that may have impaired the study's ability to assess the impact of nutrigenomic information to improve diet and health.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Personalized nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized nutritionOther
Receives individualized nutrition information
| Study group | Role | What they receive |
|---|---|---|
| Personalized nutrition intervention | Experimental | Participant receives gene-test results plus personalized nutrition information from a registered dietician Receives: Other: Personalized nutrition |
| Usual nutrigenomics intervention | Placebo comparator | Participant receives usual nutrigenomics intervention (direct-to-consumer) Receives: Other: Personalized nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet quality
Healthy eating index
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start15 Mar 2017
- Primary completion30 Nov 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwantlen Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Karen Davison, Kwantlen Polytechnic University
- Investigators
- Karen Davison, PhD, Principal investigator, Kwantlen Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310814
- Sponsor's protocol ID
- 500692 - 16
- Status last verified
- Oct 2017
- First submitted
- 29 Aug 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31254340Littlejohn 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.
PubMed 29891470
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building New Nutrigenomics Technology Interface Tools for Consumers and Health Professionals
- ClinicalTrials.gov ID
- NCT03310814
- Acronym / sponsor ID
- 500692 - 16
- Conditions
- Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kwantlen Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized nutrition intervention | Experimental | Other: Personalized nutritionParticipant receives gene-test results plus personalized nutrition information from a registered dietician |
| Usual nutrigenomics intervention | Placebo comparator | Other: Personalized nutritionParticipant receives usual nutrigenomics intervention (direct-to-consumer) |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized nutritionReceives individualized nutrition information | Other | Personalized nutrition intervention, Usual nutrigenomics intervention |
Primary outcome
Diet quality
Time frame: 8 weeks
Healthy eating index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Derived from this study: PubMed 31254340Araujo 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.
- Derived from this study: PubMed 29891470Littlejohn 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Davison, PhD principal investigator
Kwantlen Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized nutrition in people with Adult, run by Kwantlen Polytechnic University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet quality (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310814, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017; AzTrials last refreshed its copy on 27 Oct 2026.