Depression Clinical Trial
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.
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.
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