DNA-based Dietary Advice for Adults With Depressive Disorders

October 13, 2017 updated by: Karen Davison

An Investigation of DNA-based Dietary Advice and Its Effects on Changing Health Behaviours in Adults With Depressive Disorders: A Mixed Methods Study to Evaluate Efficacy and Participant Experiences

To evaluate the feasibility of nutrigenomics as an intervention for mental health conditions, a phase I randomized controlled trial of 42 adults (19 to 50 years) with depressive disorders using a 2:1 ratio of group selection (28 in the intervention {I} group and 14 in the control {C} group) is proposed. Participants with a confirmed depressive disorder will be recruited from two local mental health clinics. Those randomized into the I group will do the gene testing and be provided personalized DNA-based dietary advice from a registered dietitian; those in the C group will also receive testing but be given general dietary advice by a registered dietitian. Pre- and post-intervention comparisons (3 and 6 weeks after a personalized nutrition plan is given) will be analyzed based on records of dietary intakes (i.e., 3 day food records and food frequency questionnaire) and psychiatric functioning (e.g., Quick Inventory of Depressive Symptomology, Hospital Anxiety and Depression Scale, Outcome Questionnaire - OQ-45). In addition, measures that track physical activity, sedentary behavior, and sleep quality as well as sociodemographics will be included as covariates. After the intervention study is completed, in-depth focus group interviews will be conducted. Participants will be asked questions that will elicit their perceptions of the nutrigenomics test and the personalized dietary advice provided as well as the behavioural response to disclosure of genetic information.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

While evidence suggests that the disclosure of personal genetic information based on nutrigenomics testing leads to lifestyle behaviour changes in selected populations, the potential for its use as an intervention in clinical populations, such as those with depressive disorders, has yet to be explored.

Study Objectives: The proposed study will employ a mixed-methods approach and focus on the following objectives:

  1. to examine the efficacy of testing for 12-genes (i.e., CYP1A2, UCP1, MTHFR, HLA, TMPRSS6, TFR2, TF, MCM6, NOS3, ACE, FUT2, GSTT1, TCF7L2) that assess 11 dietary components (i.e, caffeine, energy balance, folate gluten, iron, lactose, omega-3 fat, sodium, vitamin B12, vitamin C, and whole grains) in changing diet quality, eating behaviours and improving symptoms in adults with depressive disorders
  2. to conduct a qualitative investigation of participants' experiences with using gene testing that assesses for dietary components

Summary of Method: To evaluate the feasibility of nutrigenomics as an intervention for mental health conditions, a phase I randomized controlled trial of 24 adults with depressive disorders using a 2:1 ratio of group selection (16 in the intervention {I} group and 8 in the control {C} group) is proposed. Participants with a confirmed depressive disorder will be recruited from two local mental health clinics. Those randomized into the I group will do the gene testing and be provided personalized DNA-based dietary advice from a registered dietitian; those in the C group will also receive testing but be given general dietary advice by a registered dietitian. Pre- and post-intervention comparisons (3 and 6 weeks after a personalized nutrition plan is given) will be analyzed based on records of dietary intakes (i.e., 3 day food records and food frequency questionnaire) and psychiatric functioning (e.g., Quick Inventory of Depressive Symptomology, Hospital Anxiety and Depression Scale, Outcome Questionnaire - OQ-45). In addition, measures that track physical activity, sedentary behavior, and sleep quality as well as sociodemographics will be included as covariates.

After the intervention study is completed, in-depth focus group interviews will be conducted. Participants will be asked questions that will elicit their perceptions of the nutrigenomics test and the personalized dietary advice provided as well as the behavioural response to disclosure of genetic information.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada
        • Recruiting
        • Innovation Boulevard
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects who are living in the community and 19 years of age or older.
  2. Mild to moderate depression as measured by the Quick Inventory of Depressive Symptomology (QIDS10).
  3. A level of understanding sufficient to perform all tests and examinations required by the protocol.

Exclusion Criteria:

  1. Investigators and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
  2. Current or lifetime diagnosis of any of the following according to DSM-IV or DSM-5 criteria: Schizophrenia Spectrum and Other Psychotic Disorders, Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Dementia of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition.
  3. Alcohol or drug dependence during the previous 12 months. Participants must have consumed less than 10 alcoholic beverages per week in the previous 4 weeks and had no use of marijuana and other illicit drugs. At each visit, participants will be asked for an estimate of their use of each of these substances, and these amounts will be recorded for possible later statistical analysis.
  4. Hospitalization for treatment of a mental health condition within the previous 6 months.
  5. Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count <500 mm3).
  6. Indication of treatment resistance (e.g., has been given more than 3 treatments for depression).
  7. Not taking any atypical antipsychotics or anti-depressants that have an appetite stimulating effect (e.g., Mirtazapine)
  8. Uncorrected hypothyroidism or hyperthyroidism in the previous 12 months.
  9. Diagnosed Inflammatory Bowel Syndrome, or any other chronic gastrointestinal problem.
  10. Treatment with electroconvulsive therapy (ECT) within previous 6 months.
  11. Patients will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks. If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study.
  12. Taking any type of nutritional or herbal supplement, including melatonin, known to have a centrally-acting effect. However, participants who have been taking supplements such as Echinacea, chondroitin, or glucosamine may enter the study if a) they have been taking these agents for at least one month prior to the study, and b) they continue on these agents throughout the study. Supplement information will be presented at intake, and the cessation of any such supplements will be required for the participant to continue in screening.
  13. Women who are pregnant or breast-feeding; women of childbearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse (for example, intrauterine device, oral contraceptive, implant, Depo-Provera, or barrier devices with spermicide). Women who become pregnant during the trial will be withdrawn.
  14. Any person judged clinically to be at serious risk for suicide or violence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personalized Nutrition
Participant receives gene test results with diet plan (personalized nutrition)
Behavioral: Personalized Nutrition
Diet plan based on nutrition-related gene test results
Placebo Comparator: Gene Test Report Only
Participant receives standard diet plan
Behavioral: Personalized Nutrition
Diet plan based on nutrition-related gene test results

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Outcome Questionnaire-45
Time Frame: 3 months
Measures symptom distress (depression and anxiety), interpersonal relationships, Social Role (difficulties in the workplace, school or home duties)
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in healthy eating index scores
Time Frame: 3 months
Healthy eating index
3 months
General self-efficacy scale
Time Frame: 3 months
Measures optimistic self-beliefs to cope with a variety of difficult demands in life.
3 months
Quick Inventory of Depressive Symptomology
Time Frame: 3 months
Measures depression symptoms
3 months
Hospital Anxiety and Depression Scale
Time Frame: 3 months
Measures anxiety and depression symptoms
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karen Davison

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen M Davison, PhD, Kwantlen Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KK17-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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