DepressionNCT03310827
DNA-based Dietary Advice for Adults With Depressive Disorders
A study testing Personalized Nutrition in people with Depression, run by Karen Davison at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Personalized Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2017to 30 Jun 2018
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects who are living in the community and 19 years of age or older.
- Mild to moderate depression as measured by the Quick Inventory of Depressive Symptomology (QIDS10).
- A level of understanding sufficient to perform all tests and examinations required by the protocol.
Who cannot join
- Investigators and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- 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.
- 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.
- Hospitalization for treatment of a mental health condition within the previous 6 months.
- 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).
- Indication of treatment resistance (e.g., has been given more than 3 treatments for depression).
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- Not taking any atypical antipsychotics or anti-depressants that have an appetite stimulating effect (e.g., Mirtazapine)
- Uncorrected hypothyroidism or hyperthyroidism in the previous 12 months.
- Diagnosed Inflammatory Bowel Syndrome, or any other chronic gastrointestinal problem.
- Treatment with electroconvulsive therapy (ECT) within previous 6 months.
- 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.
- 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.
- 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.
- Any person judged clinically to be at serious risk for suicide or violence.
Trial locations and contacts
1 site in 1 country.
Erin Brown, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Innovation Boulevard
Surrey, British Columbia
Karen Davison, PhD, 604-300-0331, karen.davison@kpu.ca
About this study
Official title: 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.
Read the 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:
- 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
- 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.
- Conditions
- Depression
- Being tested
- Personalized Nutrition
- Keywords
- Nutrition, Nutrigenomics
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized NutritionBehavioural
Diet plan based on nutrition-related gene test results
| Study group | Role | What they receive |
|---|---|---|
| Personalized Nutrition | Experimental | Participant receives gene test results with diet plan (personalized nutrition) Receives: Behavioral: Personalized Nutrition |
| Gene Test Report Only | Placebo comparator | Participant receives standard diet plan Receives: Behavioral: Personalized Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Questionnaire-45
Measures symptom distress (depression and anxiety), interpersonal relationships, Social Role (difficulties in the workplace, school or home duties)
Measured: 3 months
Secondary outcomes (4)
Changes in healthy eating index scores
Healthy eating index
Measured: 3 months
General self-efficacy scale
Measures optimistic self-beliefs to cope with a variety of difficult demands in life.
Measured: 3 months
Quick Inventory of Depressive Symptomology
Measures depression symptoms
Measured: 3 months
Hospital Anxiety and Depression Scale
Measures anxiety and depression symptoms
Measured: 3 months
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 start19 Sep 2017
- Primary completion31 Jan 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karen Davison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karen Davison, Kwantlen Polytechnic University
- Investigators
- Karen M Davison, PhD, Principal investigator, Kwantlen Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310827
- Sponsor's protocol ID
- KK17-01
- Status last verified
- Oct 2017
- First submitted
- 20 Sep 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- 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
- ClinicalTrials.gov ID
- NCT03310827
- Acronym / sponsor ID
- KK17-01
- Conditions
- Depression
- Keywords
- Nutrition, Nutrigenomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Karen DavisonUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 30 Jun 2018 (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.
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.
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:
- 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
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personalized Nutrition | Experimental | Behavioral: Personalized NutritionParticipant receives gene test results with diet plan (personalized nutrition) |
| Gene Test Report Only | Placebo comparator | Behavioral: Personalized NutritionParticipant receives standard diet plan |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female subjects who are living in the community and 19 years of age or older.
- Mild to moderate depression as measured by the Quick Inventory of Depressive Symptomology (QIDS10).
- A level of understanding sufficient to perform all tests and examinations required by the protocol.
Key exclusion criteria (14 listed)
- Investigators and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- 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.
- 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.
- Hospitalization for treatment of a mental health condition within the previous 6 months.
- 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).
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 NutritionDiet plan based on nutrition-related gene test results | Behavioural | Gene Test Report Only, Personalized Nutrition |
Primary outcome
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)
4 secondary outcomes
Changes in healthy eating index scores
Time frame: 3 months
General self-efficacy scale
Time frame: 3 months
Quick Inventory of Depressive Symptomology
Time frame: 3 months
Hospital Anxiety and Depression Scale
Time frame: 3 months
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.
- Individual participant dataSharing planned: No
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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.
Erin Brown, MSc contact
Karen M 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 Depression, run by Karen Davison 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 3 inclusion and 14 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?
Contact Karen M Davison, PhD (604-300-0331, karen.davison@kpu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Questionnaire-45 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.