Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001433594
Ethics application status
Approved
Date submitted
14/11/2024
Date registered
9/12/2024
Date last updated
9/12/2024
Date data sharing statement initially provided
9/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
ANTIC Study: A Nutrition Trial in Chronic obstructive pulmonary disease (COPD)
Scientific title
A phase 2, prospective, randomised, open, blinded end-point (PROBE), controlled, cross-over, multi-centre, assessing the effect of a nutritional intervention on IL-6 levels in adults aged 40 years and over with chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 313381 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory 335749 0
Condition category
Condition code
Respiratory 332304 332304 0 0
Chronic obstructive pulmonary disease
Diet and Nutrition 332398 332398 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ANTIC is a 3-way crossover trial, with each intervention period run for 4 weeks, with a 4-week washout between each intervention. Interventions to be tested are:
• Inulin, 6 grams of powder to be taken twice daily with food (mixed into usual meals) or liquid
• High Amylose Maize Starch, 10 grams of powder taken twice daily with food (mixed into usual meals) or liquid
• Control period, usual dietary intake.

Patients will record intake in a patient diary. At the end of each intervention, the powder will be returned.
Intervention code [1] 329961 0
Treatment: Other
Comparator / control treatment
There is a control period- 4 weeks of normal dietary intake.
Control group
Active

Outcomes
Primary outcome [1] 339882 0
To assess plasma concentrations of IL-6 following 4-week nutrition interventions.
Timepoint [1] 339882 0
Baseline, pre and post each intervention period
Secondary outcome [1] 441745 0
To assess the impact of nutrition interventions on quality of life for participants with COPD.
Timepoint [1] 441745 0
baseline, pre and post each intervention period

Eligibility
Key inclusion criteria
1. Adults aged 40 years and over,
2. Current or ex-smokers (with smoking history >=10 pack years),
3. Have a diagnosis of COPD with a post-bronchodilator ratio of forced expiratory volume (FEV1) to forced vital capacity of less than 0·7,
4. On stable COPD-directed medication for 28 days prior to screening,
5. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids in the 28 days prior to screening,
2. Co-morbid lung diseases (lung cancer, interstitial lung disease, bronchiectasis). A diagnosis of asthma is allowed if COPD is the primary condition.
3. Habitual fibre intake no more than 40g per day.
4. Use of fibre-based supplements in the preceding 28 days prior to enrolment,
5. Significant digestive issues, such as inflammatory bowel disease, hereditary fructose intolerance.

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)
Eligibility is to be assessed prior to generating a sequence allocation in REDCap. Allocation would be considered concealed and using REDCap would be classified as "central randomisation".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence is generated using random permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 120 participants would provide 90% power for a level 0.05 test to detect a GMR of 0.75 (e.g., a reduction in the geometric mean IL-6 concentration from 4 pg/ml to 3 pg/ml) for a within-subject geometric standard deviation of 1.98.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
11/01/2027
Actual
Date of last data collection
Anticipated
7/06/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 317822 0
Government body
Name [1] 317822 0
NHMRC Synergy Grant
Country [1] 317822 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320152 0
University
Name [1] 320152 0
University of Technology
Address [1] 320152 0
Country [1] 320152 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316506 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 316506 0
Ethics committee country [1] 316506 0
Australia
Date submitted for ethics approval [1] 316506 0
Approval date [1] 316506 0
21/08/2024
Ethics approval number [1] 316506 0

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

Contacts
Principal investigator
Name 138110 0
Prof Meg Jardine
Address 138110 0
NHMRC Clinical Trial Centre, 119-143 Missenden Road, Camperdown NSW 2021
Country 138110 0
Australia
Phone 138110 0
+61 2 9562 5005
Fax 138110 0
Email 138110 0
meg.jardine@sydney.edu.au
Contact person for public queries
Name 138111 0
Camilla Herberstein
Address 138111 0
NHMRC Clinical Trial Centre, 119-143 Missenden Road, Camperdown NSW 2021
Country 138111 0
Australia
Phone 138111 0
+61 02 95625023
Fax 138111 0
Email 138111 0
antic.study@sydney.edu.au
Contact person for scientific queries
Name 138112 0
Meg Jardine
Address 138112 0
NHMRC Clinical Trial Centre, 119-143 Missenden Road, Camperdown NSW 2021
Country 138112 0
Australia
Phone 138112 0
+61 2 9562 5005
Fax 138112 0
Email 138112 0
meg.jardine@sydney.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.