Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000074594
Ethics application status
Approved
Date submitted
22/12/2023
Date registered
30/01/2024
Date last updated
7/02/2024
Date data sharing statement initially provided
30/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the impact of consuming legumes on diet quality and mood in healthy young adults
Scientific title
Assessing the impact of dietary intake of legumes on diet quality and mood in healthy young adults
Secondary ID [1] 311183 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mood Disorders 332429 0
Diet Quality 332456 0
Condition category
Condition code
Mental Health 329117 329117 0 0
Depression
Mental Health 329150 329150 0 0
Anxiety
Diet and Nutrition 329151 329151 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention will take place in the nutrition and dietetics teaching laboratory at the University of Canberra. Participants will be provided with three evening meals per week for a four-week period. There will be two arms:
1. Intervention arm will receive meals that contain 100g of legumes e.g., spaghetti bolognaise made with legumes.
2. Control arm will receive an isocaloric meal without legumes.

Other than the meals provided, participants will continue with their habitual diet with no restrictions placed on consumption at any other time of the day.
All provided meals will be developed by an Accredited Practicing Dietitian with 3 years experience. Meals will be cooked on site at the University of Canberra in the teaching laboratory and will provide approximately 2000kJs per serve with an average of 2 serves of grains and protein and at least 3 serves of vegetables. All meals will be served as the evening meal on Tuesday, Wednesday and Thursday with participants able to eat as much as needed. Any meals only partially consumed will be recorded.
Intervention code [1] 327682 0
Lifestyle
Intervention code [2] 327783 0
Treatment: Other
Comparator / control treatment
This study will take place in the nutrition and dietetics teaching laboratory at the University of Canberra. Participants will be provided with three evening meals per week for a four week period. The control arm will receive healthy meals that do not contain legumes.
Healthy meals will meet the Australian Healthy Eating Guidelines and provide approximately 200kJs per serve with an average of 2 serves of grains, 1 of protein and 3 serves of vegetables. All provided meals will be developed by an Accredited Practicing Dietitian with 3 years experience . Meals will be cooked on site at the University of Canberra in the teaching laboratory
Control group
Active

Outcomes
Primary outcome [1] 336982 0
change in mood
Timepoint [1] 336982 0
at baseline and 4 weeks after intervention commencement
Secondary outcome [1] 430295 0
change in diet quality
Timepoint [1] 430295 0
at baseline and 4 weeks after intervention commencement
Secondary outcome [2] 430296 0
change in physical activity habits
Timepoint [2] 430296 0
at baseline, week 2, 3 and 4 weeks after intervention commencement
Secondary outcome [3] 430297 0
change in sleep quality
Timepoint [3] 430297 0
at baseline and 4 weeks after intervention commencement
Secondary outcome [4] 430298 0
change in gastrointestinal symptoms
Timepoint [4] 430298 0
at baseline, week 2, 3 and 4 weeks after intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria:
- Healthy adults (18-25 years)
- Poor diet quality (based on CSIRO Healthy Diet Score <40)
- Habitual consumption of legumes < 1 serve/week
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria:
- Current or previous diagnosis of eating disorders
- Current dietary restrictions e.g. allergies or coeliac disease
- Current diagnosis of mental health conditions
- Current diagnosis of chronic conditions known to be comorbid with mood disorders e.g. Irritable Bowel Syndrome, diabetes
- Consumption of a vegetarian diet

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2025
Actual
Date of last participant enrolment
Anticipated
20/02/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 41796 0
2617 - University Of Canberra

Funding & Sponsors
Funding source category [1] 315441 0
University
Name [1] 315441 0
University of Canberra
Country [1] 315441 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari St., Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 317512 0
None
Name [1] 317512 0
Address [1] 317512 0
Country [1] 317512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314353 0
University of Canberra Human Ethics Committee
Ethics committee address [1] 314353 0
11 Kirinari St. Bruce ACT 2617
Ethics committee country [1] 314353 0
Australia
Date submitted for ethics approval [1] 314353 0
07/11/2023
Approval date [1] 314353 0
19/01/2024
Ethics approval number [1] 314353 0

Summary
Brief summary
The study aims to investigate the impact of legume consumption on mood. It is a 4 week randomized controlled trial where three meals per week are provided to the participants. The meals will be matched for macronutrient content between the control and intervention groups. The primary endpoint is understanding change in mood due to legume consumption. Secondary measures will consider impact of legume consumption on gastrointestinal symptoms, diet and sleep quality and physical activity. All study visits will be conducted at the nutrition teaching laboratory at the University of Canberra.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131286 0
Dr Michelle Minehan
Address 131286 0
University of Canberra, Faculty of Health, 11 Kirinari St., Bruce ACT, 2617
Country 131286 0
Australia
Phone 131286 0
+61 2 479 047 749
Fax 131286 0
Email 131286 0
michelle.minehan@canberra.edu.au
Contact person for public queries
Name 131287 0
Mrs Simone O'Neill
Address 131287 0
University of Canberra, Faculty of Health, 11 Kirinari St., Bruce ACT, 2617
Country 131287 0
Australia
Phone 131287 0
+61 413 681 476
Fax 131287 0
Email 131287 0
simone.oneill@canberra.edu.au
Contact person for scientific queries
Name 131288 0
Mrs Simone O'Neill
Address 131288 0
University of Canberra, Faculty of Health, 11 Kirinari St., Bruce ACT, 2617
Country 131288 0
Australia
Phone 131288 0
+61 413 681 476
Fax 131288 0
Email 131288 0
simone.oneill@canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.