Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-04 @ 8:23 PM
Study NCT ID:
NCT03310827
Status:
UNKNOWN
Last Update Posted:
2017-10-16
First Post:
2017-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA-based Dietary Advice for Adults With Depressive Disorders
Sponsor:
Karen Davison
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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:
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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: