Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001162606
Ethics application status
Approved
Date submitted
18/09/2023
Date registered
9/11/2023
Date last updated
3/03/2024
Date data sharing statement initially provided
9/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of two dietary patterns in people with depression: A proof-of-concept trial
Scientific title
Evaluation of two dietary patterns in people with depression: A proof-of-concept trial
Secondary ID [1] 310461 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 331257 0
Condition category
Condition code
Mental Health 328012 328012 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend study visits in-clinic at baseline and week 4 at the Health Education and Research Building (HERB), Barwon Health, Geelong. A whole-diet intervention that provides a balance of protein, carbohydrate and fat will be provided to participants for 4 weeks. A 7-day meal plan, which meets the food group targets of the intervention diet, was developed for two energy levels (Level 1 - 8MJ/day, Level 2 - 10MJ/day). Participants will be allocated to Level 1 or Level 2 based on an assessment of their habitual diet at baseline by a dietitian and may be adjusted at subsequent weekly calls to meet an individual’s energy requirements, based on dietetic assessment (e.g. assessment of individual’s weight, hunger levels). Three meals and three snacks will be provided to participants for the duration of the study. Participants will receive dietary information one-on-one from a dietitian at baseline and will be provided with a study booklet developed for the purpose of the study. One-on-one baseline and week 4 visits will be approximately 2 hours in duration each. During the intervention, participants will meet weekly with a study investigator (dietitian) online which will be approximately 20 minutes in duration. Diet adherence will be assessed via the completion of daily food adherence logs which will be returned to researchers at the final study visit.
Intervention code [1] 326995 0
Lifestyle
Comparator / control treatment
Participants will attend study visits in-clinic at baseline and week 4 at the Health Education and Research Building (HERB), Barwon Health, Geelong. A whole-diet control intervention that provides a balance of protein, carbohydrate and fat, in differing ratios to the intervention diet, will be provided to participants for 4 weeks. A 7-day meal plan, which meets the food group targets of the control diet, was developed for two energy levels (Level 1 - 8MJ/day, Level 2 - 10MJ/day). Participants will be allocated to Level 1 or Level 2 based on an assessment of their habitual diet at baseline by a dietitian and may be adjusted at subsequent weekly calls to meet an individual’s energy requirements, based on dietetic assessment (e.g. assessment of individual’s weight, hunger levels). Three meals and three snacks will be provided to participants for the duration of the study. Participants will receive dietary information one-on-one from a dietitian at baseline and will be provided with a study booklet developed for the purpose of the study. One-on-one baseline and week 4 visits will be approximately 2 hours in duration each. During the intervention, participants will meet weekly with a study investigator (dietitian) online which will be approximately 20 minutes in duration. Diet adherence will be assessed via the completion of daily food adherence logs which will be returned to researchers at the final study visit.
Control group
Active

Outcomes
Primary outcome [1] 335879 0
Clinician-rated depressive symptoms assessed using the Montgomery-Asberg Depression Rating Scale (MADRS).
Timepoint [1] 335879 0
Baseline and week 4 post-diet commencement.
Secondary outcome [1] 425957 0
Participant-rated depressive symptoms assessed using the 9-item Patient Health Questionnaire (PHQ-9).
Timepoint [1] 425957 0
Baseline, week 2, week 4 post-diet commencement.
Secondary outcome [2] 425958 0
Participant-rated anxiety symptoms assessed using the Generalised Anxiety Disorder (GAD-7).
Timepoint [2] 425958 0
Baseline and week 4 post-diet commencement.
Secondary outcome [3] 425959 0
Participant-rated quality of life assessed using the World Health Organizations Quality of Life Short Version Scale (WHOQOL-BREF).
Timepoint [3] 425959 0
Baseline and week 4 post-diet commencement.
Secondary outcome [4] 425960 0
Any change in participants’ overall perception of their depressive symptoms assessed using the Patient Global Impression-Improvement (PGI-I) scale.
Timepoint [4] 425960 0
Baseline, week 1, week, 2, week 3, week 4 post-diet commencement.
Secondary outcome [5] 425962 0
Stool frequency assessed using the Bristol Stool Form Scale (BSFS).
Timepoint [5] 425962 0
Baseline, week 1, week 4 post-diet commencement.
Secondary outcome [6] 425970 0
Gut microbiome composition assessed via analysis of stool samples.
Timepoint [6] 425970 0
Baseline and week 4 post-diet commencement.
Secondary outcome [7] 426002 0
Diet feasibility assessed via food adherence logs in each group.
Timepoint [7] 426002 0
Baseline and week 4 post-diet commencement.
Secondary outcome [8] 426003 0
Body weight measured using calibrated scales in-clinic.
Timepoint [8] 426003 0
Baseline and week 4 post-diet commencement.
Secondary outcome [9] 426004 0
Sleep quality assessed using the single-item sleep quality scale (SQS).
Timepoint [9] 426004 0
Baseline and week 4 post-diet commencement.
Secondary outcome [10] 426005 0
Physical activity assessed using the five-item Simple Physical Activity Questionnaire (SIMPAQ).
Timepoint [10] 426005 0
Baseline and week 4 post-diet commencement.
Secondary outcome [11] 427621 0
Inflammatory markers (cytokines) measured via plasma.
Timepoint [11] 427621 0
Baseline and week 4 post-diet commencement.
Secondary outcome [12] 427622 0
Fasted tryptophan measured via plasma.
Timepoint [12] 427622 0
Baseline and week 4 post-diet commencement.
Secondary outcome [13] 427623 0
C-reactive protein measured via plasma.
Timepoint [13] 427623 0
Baseline and week 4 post-diet commencement.
Secondary outcome [14] 427624 0
Markers of gut permeability (sCD14) measured via plasma.
Timepoint [14] 427624 0
Baseline and week 4 post-diet commencement.
Secondary outcome [15] 427625 0
Brain Derived Neurotrophic Factor (BDNF) measured via serum.
Timepoint [15] 427625 0
Baseline and week 4 post-diet commencement.
Secondary outcome [16] 427626 0
Cortisol measured via plasma.
Timepoint [16] 427626 0
Baseline and week 4 post-diet commencement.
Secondary outcome [17] 427627 0
Diet acceptability measured using an adapted Diet Acceptability Questionnaire.
Timepoint [17] 427627 0
Baseline and week 4 post-diet commencement.
Secondary outcome [18] 427628 0
Diet tolerability assessed using a gastrointestinal symptom questionnaire.
Timepoint [18] 427628 0
Baseline, week 1, and week 4 post-diet commencement.
Secondary outcome [19] 428157 0
Stool consistency assessed using the Bristol Stool Form Scale (BSFS).
Timepoint [19] 428157 0
Baseline, week 1, week 4 post-diet commencement.
Secondary outcome [20] 428158 0
Gut microbiome metabolites assessed via analysis of stool samples.
Timepoint [20] 428158 0
Baseline and week 4 post-diet commencement.
Secondary outcome [21] 428159 0
Kynurenine pathway metabolites measured via plasma.
Timepoint [21] 428159 0
Baseline and week 4 post-diet commencement.
Secondary outcome [22] 428160 0
Markers of gut permeability (LPS) measured via plasma.
Timepoint [22] 428160 0
Baseline and week 4 post-diet commencement.
Secondary outcome [23] 428161 0
Markers of gut permeability (LBP) measured via plasma.
Timepoint [23] 428161 0
Baseline and week 4 post-diet commencement.
Secondary outcome [24] 428162 0
Markers of gut permeability (IgM) measured via plasma.
Timepoint [24] 428162 0
Baseline and week 4 post-diet commencement.
Secondary outcome [25] 428163 0
Markers of gut permeability (IgA) measured via plasma.
Timepoint [25] 428163 0
Baseline and week 4 post-diet commencement.
Secondary outcome [26] 428166 0
Markers of gut permeability (IgG) measured via plasma.
Timepoint [26] 428166 0
Baseline and week 4 post-diet commencement.
Secondary outcome [27] 428215 0
Short-chain fatty acids measured via serum.
Timepoint [27] 428215 0
Baseline and week 4 post-diet commencement.
Secondary outcome [28] 432341 0
Expectancy measured via Credibility Expectancy Questionnaire (CEQ)
Timepoint [28] 432341 0
Secondary outcome [29] 432342 0
Expectancy measured via Credibility Expectancy Questionnaire (CEQ)
Timepoint [29] 432342 0
Baseline

Eligibility
Key inclusion criteria
Inclusion criteria:
• Adults aged 18-65 years
• Successfully fulfilled the Diagnostic and Statistical manual of Mental Disorders (DSM-5) diagnostic criteria for a major depressive episode, determined using the SCID-5-RV
• Moderate or severe depressive symptoms based on score equal to or greater than 20 on MADRS
• Poor diet quality (based on an adapted Total Diet Score)
• Willing and able to undertake and adhere to the requirements of a 4-week feeding trial and attend all study appointments
• Reside in meal delivery zones
• Must be able to read and understand materials written in English
• Have access to a smartphone/tablet/computer with internet access and kitchen facilities (e.g., microwave/oven, freezer)
• Have a nominated preferred general practitioner
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
• Diagnosis of complex medical disorder (e.g., cancer, type 1 and 2 diabetes, dementia, heart failure, chronic obstructive pulmonary disease)
• History of major GI surgery (e.g., gastrectomy, any GI resection, colectomy)
• Clinician-diagnosed irritable bowel syndrome or inflammatory bowel disease reported by participant
• Comorbid psychiatric diagnosis by clinician of bipolar I or II disorder, psychotic disorder or personality disorder reported by participant
• Clinician diagnosed substance use disorder reported by participant and/or excess alcohol intake (>10 standard drinks per week or >4 standard drinks on any one day)
• Clinician diagnosed eating disorder reported by participant or score equal to or greater than 3 on the SCOFF eating disorder screening questionnaire or history of purging, binge eating or laxative abuse
• Two or more failed trials of antidepressant therapy for the current major depressive episode
• Dietary restrictions, food allergies, intolerances or aversions, that would interfere with consuming intervention foods (e.g., food allergy, coeliac disease, veganism, lacto-ovo vegetarianism)
• Sociocultural, religious or medical reasons which preclude participation
• Females who report to be pregnant or breastfeeding
• Individuals who exceed the minimal physical activity guidelines of 150 min/wk or underweight (BMI <18.5 kg/m2) or class III obesity (>40 kg/m2) or unstable weight (loss/gain) over the past 3 months (> 5%)
• Current participation in another clinical trial
• Probiotic, prebiotic and/or synbiotic supplementation in the past 4 weeks
• Antibiotic use in the past 4 weeks
• For participants currently prescribed antidepressant or psychotherapy: change in antidepressant therapy and/or psychotherapy in the 4 weeks prior to randomisation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be generated by a third-party statistician, independent of the research team. The treatment allocation will be conducted by the researcher conducting the baseline visits after all baseline assessments are complete. The randomisation schedule and coding of group allocations will not be accessible to the researchers collecting the data at any time.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants with MDD (n=44) will be randomised to the intervention arm using computer-generated block randomisation, with varying block sizes of 2 and 4, in a 1:1 ratio (intervention to control).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/11/2023
Actual
17/01/2024
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25513 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 41333 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 314667 0
Government body
Name [1] 314667 0
National Health and Medical Research Council
Country [1] 314667 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Road Waurn Ponds VIC 3216 Australia
Country
Australia
Secondary sponsor category [1] 316633 0
None
Name [1] 316633 0
Address [1] 316633 0
Country [1] 316633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313686 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 313686 0
Ethics committee country [1] 313686 0
Australia
Date submitted for ethics approval [1] 313686 0
31/05/2023
Approval date [1] 313686 0
17/08/2023
Ethics approval number [1] 313686 0
23/75

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129010 0
Dr Heidi Staudacher
Address 129010 0
Food & Mood Centre, IMPACT Institute, Deakin University PO Box 281 Geelong, VIC 3220
Country 129010 0
Australia
Phone 129010 0
+61 3 522 78891
Fax 129010 0
Email 129010 0
[email protected]
Contact person for public queries
Name 129011 0
Delyse Tien
Address 129011 0
Food & Mood Centre, IMPACT Institute, Deakin University PO Box 281 Geelong, VIC 3220
Country 129011 0
Australia
Phone 129011 0
+61 3 522 72688
Fax 129011 0
Email 129011 0
[email protected]
Contact person for scientific queries
Name 129012 0
Delyse Tien
Address 129012 0
Food & Mood Centre, IMPACT Institute, Deakin University PO Box 281 Geelong, VIC 3220
Country 129012 0
Australia
Phone 129012 0
+61 3 522 72688
Fax 129012 0
Email 129012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data supporting the publication results.
When will data be available (start and end dates)?
Data are available straight after publication.
Data are available for an indefinite time.
Start date: Pending publication.
End date: Unknown.
Available to whom?
Data are potentially available to researchers based in any location. All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Available for what types of analyses?
Assessed on a case-by-case basis. Subject to approval by the Principal Investigator.
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial. For further information, see our data sharing policy: https://policy.deakin.edu.au/view.current.php?id=00023


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.