Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000108516
Ethics application status
Approved
Date submitted
22/01/2024
Date registered
8/02/2024
Date last updated
8/02/2024
Date data sharing statement initially provided
8/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a dietary pattern in healthy volunteers: A proof-of-concept trial
Scientific title
Evaluation of a dietary pattern in healthy volunteers: A proof-of-concept trial
Secondary ID [1] 311264 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12623001162606, this trial will recruit healthy volunteers in parallel to those with major depression as part of the OPTIMISM trial.

Health condition
Health condition(s) or problem(s) studied:
Depression 332577 0
Condition category
Condition code
Mental Health 329180 329180 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 each day 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] 327718 0
Lifestyle
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337021 0
Clinician-rated depressive symptoms.
Timepoint [1] 337021 0
Baseline and week 4 post-diet commencement.
Secondary outcome [1] 430375 0
Participant-rated depressive symptoms.
Timepoint [1] 430375 0
Baseline, week 2, week 4 post-diet commencement.
Secondary outcome [2] 430376 0
Participant-rated anxiety symptoms.
Timepoint [2] 430376 0
Baseline and week 4 post-diet commencement.
Secondary outcome [3] 430377 0
Participant-rated quality of life.
Timepoint [3] 430377 0
Baseline and week 4 post-diet commencement.
Secondary outcome [4] 430378 0
Any change in participants’ overall perception of their depressive symptoms.
Timepoint [4] 430378 0
Baseline, week 1, week, 2, week 3, week 4 post-diet commencement.
Secondary outcome [5] 430379 0
Stool frequency.
Timepoint [5] 430379 0
Baseline, week 1, week 4 post-diet commencement.
Secondary outcome [6] 430380 0
Stool consistency.
Timepoint [6] 430380 0
Baseline, week 1, week 4 post-diet commencement.
Secondary outcome [7] 430381 0
Gut microbiome composition.
Timepoint [7] 430381 0
Baseline and week 4 post-diet commencement.
Secondary outcome [8] 430382 0
Diet feasibility.
Timepoint [8] 430382 0
Baseline and week 4 post-diet commencement.
Secondary outcome [9] 430383 0
Body weight.
Timepoint [9] 430383 0
Baseline and week 4 post-diet commencement.
Secondary outcome [10] 430384 0
Sleep quality.
Timepoint [10] 430384 0
Baseline and week 4 post-diet commencement.
Secondary outcome [11] 430385 0
Physical activity.
Timepoint [11] 430385 0
Baseline and week 4 post-diet commencement.
Secondary outcome [12] 430386 0
Inflammatory markers (cytokines).
Timepoint [12] 430386 0
Baseline and week 4 post-diet commencement.
Secondary outcome [13] 430387 0
Fasted tryptophan.
Timepoint [13] 430387 0
Baseline and week 4 post-diet commencement.
Secondary outcome [14] 430388 0
C-reactive protein.
Timepoint [14] 430388 0
Baseline and week 4 post-diet commencement.
Secondary outcome [15] 430389 0
Markers of gut permeability (sCD14).
Timepoint [15] 430389 0
Baseline and week 4 post-diet commencement.
Secondary outcome [16] 430390 0
Brain Derived Neurotrophic Factor (BDNF).
Timepoint [16] 430390 0
Baseline and week 4 post-diet commencement.
Secondary outcome [17] 430391 0
Cortisol.
Timepoint [17] 430391 0
Baseline and week 4 post-diet commencement.
Secondary outcome [18] 430393 0
Diet acceptability.
Timepoint [18] 430393 0
Baseline and week 4 post-diet commencement.
Secondary outcome [19] 430394 0
Diet tolerability.
Timepoint [19] 430394 0
Baseline, week 1, and week 4 post-diet commencement.
Secondary outcome [20] 430395 0
Gut microbiome metabolites.
Timepoint [20] 430395 0
Baseline and week 4 post-diet commencement.
Secondary outcome [21] 430397 0
Kynurenine pathway metabolites.
Timepoint [21] 430397 0
Baseline and week 4 post-diet commencement.
Secondary outcome [22] 430400 0
Markers of gut permeability (LBP).
Timepoint [22] 430400 0
Baseline and week 4 post-diet commencement.
Secondary outcome [23] 430401 0
Markers of gut permeability (IgM).
Timepoint [23] 430401 0
Baseline and week 4 post-diet commencement.
Secondary outcome [24] 430402 0
Markers of gut permeability (IgA).
Timepoint [24] 430402 0
Baseline and week 4 post-diet commencement.
Secondary outcome [25] 430403 0
Markers of gut permeability (IgG).
Timepoint [25] 430403 0
Baseline and week 4 post-diet commencement.
Secondary outcome [26] 430404 0
Short-chain fatty acids.
Timepoint [26] 430404 0
Baseline and week 4 post-diet commencement.
Secondary outcome [27] 430997 0
Expectancy
Timepoint [27] 430997 0
Baseline
Secondary outcome [28] 431415 0
Markers of gut permeability (LPS).
Timepoint [28] 431415 0
Baseline and week 4 post-diet commencement.

Eligibility
Key inclusion criteria
• Adults aged 18-65 years
• Poor quality diet (as rated by an adapted Total Diet Score)
• Willing to undertake and adhere to a 4-week feeding trial (willing to consume study meals provided) 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)
• Must nominate a preferred general practitioner
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Mild, moderate or severe depressive symptoms based on score greater than or equal to 7 on MADRS
• Participants with current suicidal ideation with a specific plan, defined as a score of 5 or 6 on the MADRs item 10
• Current clinician-diagnosed major depressive disorder reported by participant or requiring medication and/or other treatment for depression
• 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, colectomy)
• Clinician-diagnosed irritable bowel syndrome or inflammatory bowel disease reported by participant
• Clinician-diagnosed 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 standard drinks/week)
• Clinician diagnosed eating disorder reported by participant or score greater than or equal to 3 on the SCOFF eating disorder screening questionnaire or history of purging, binge eating or laxative abuse
• Dietary restrictions, food allergies, intolerances or aversions, that would interfere with consuming intervention foods (I.e., food allergy coeliac disease, veganism, lacto-ovo vegetarianism)
• Sociocultural, religious, medical reasons which precludes 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%) (as energy intake requirements will be more difficult to achieve)
• Current participation in another clinical trial
• Probiotic, prebiotic and/or synbiotic supplementation in the past 4 weeks
• Antibiotic use in the past 4 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315520 0
Government body
Name [1] 315520 0
National Health and Medical Research Council
Country [1] 315520 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Road Waurn Ponds VIC 3216 Australia
Country
Australia
Secondary sponsor category [1] 317603 0
None
Name [1] 317603 0
Address [1] 317603 0
Country [1] 317603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314422 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 314422 0
Ethics committee country [1] 314422 0
Australia
Date submitted for ethics approval [1] 314422 0
31/05/2023
Approval date [1] 314422 0
17/08/2023
Ethics approval number [1] 314422 0
23/75

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

Contacts
Principal investigator
Name 131522 0
Dr Heidi Staudacher
Address 131522 0
Food & Mood Centre, IMPACT Institute, Deakin University PO Box 281 Geelong, VIC 3220
Country 131522 0
Australia
Phone 131522 0
+61 3 5227 8891
Fax 131522 0
Email 131522 0
[email protected]
Contact person for public queries
Name 131523 0
Delyse Tien
Address 131523 0
Food & Mood Centre, IMPACT Institute, Deakin University PO Box 281 Geelong, VIC 3220
Country 131523 0
Australia
Phone 131523 0
+61 3 5227 2688
Fax 131523 0
Email 131523 0
[email protected]
Contact person for scientific queries
Name 131524 0
Delyse Tien
Address 131524 0
Food & Mood Centre, IMPACT Institute, Deakin University PO Box 281 Geelong, VIC 3220
Country 131524 0
Australia
Phone 131524 0
+61 3 5227 2688
Fax 131524 0
Email 131524 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.