DNA-based Dietary Advice for Adults With Depressive Disorders

NCT03310827 | Unknown DMC

• 1 other identifier: KK17-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Nutrition; Nutrigenomics

Outcome Measures

Primary Outcomes (1)

• Outcome Questionnaire-45

  Measures symptom distress (depression and anxiety), interpersonal relationships, Social Role (difficulties in the workplace, school or home duties)

  3 months

Secondary Outcomes (4)

• Changes in healthy eating index scores

  3 months

• General self-efficacy scale

  3 months

• Quick Inventory of Depressive Symptomology

  3 months

• Hospital Anxiety and Depression Scale

  3 months

Study Arms (2)

Personalized Nutrition

EXPERIMENTAL

Participant receives gene test results with diet plan (personalized nutrition)

Behavioral: Personalized Nutrition

Gene Test Report Only

PLACEBO COMPARATOR

Participant receives standard diet plan

Behavioral: Personalized Nutrition

Interventions

Personalized Nutrition BEHAVIORAL

Diet plan based on nutrition-related gene test results

Gene Test Report Only; Personalized Nutrition

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Karen Davison: lead

Study Sites (1)

Innovation Boulevard

Surrey, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Karen M Davison, PhD

  Kwantlen Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen M Davison, PhD

CONTACT

604-300-0331; karen.davison@kpu.ca

Erin Brown, MSc

CONTACT

erin.brown@kpu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 16, 2017
• Study Start: September 19, 2017
• Primary Completion: January 31, 2018
• Study Completion: June 30, 2018
• Last Updated: October 16, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)