Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000755437p
Ethics application status
Submitted, not yet approved
Date submitted
19/05/2025
Date registered
17/07/2025
Date last updated
17/07/2025
Date data sharing statement initially provided
17/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Fruits and Vegetables for Chronic Obstructive Pulmonary Disease (COPD): A Cross-Sectional, Observational Study
Scientific title
Fruits and Vegetables for Chronic Obstructive Pulmonary Disease (COPD): A Cross-Sectional, Observational Study
Secondary ID [1] 313834 0
None
Universal Trial Number (UTN)
Trial acronym
FVC-O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 336482 0
Condition category
Condition code
Respiratory 332993 332993 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Two participant groups will be recruited:
• Group one (COPD group): Adults with a physician diagnosis of chronic obstructive pulmonary disease (COPD) as their primary respiratory condition.
• Group two (healthy control group): Adults with no diagnosed respiratory disease.
This study uses a cross-sectional design to examine the relationship between fruit and vegetable intake and COPD outcomes.
After completing a screening questionnaire, eligible participants will receive a link to complete the study questionnaires online via REDCap, accessible both in their web browser and link provided via email. Participants may begin the questionnaires immediately or return to complete them later.
The questionnaires will cover topics related to health and wellbeing, including dietary intake, quality of life, and respiratory symptoms. Specifically, participants will be asked about their medical history, medications, COPD symptoms (if applicable), diet, barriers to fruit and vegetable consumption, chronic fatigue symptoms, sleep, food access and insecurity, physical activity, and symptoms of anxiety and depression.
Fruit and vegetable intake will be assessed using the Australian Eating Survey. Participation in this study will take approximately 30-60 minutes.
Intervention code [1] 330419 0
Not applicable
Comparator / control treatment
Control Group: Healthy controls, without respiratory diagnosis
Control group
Active

Outcomes
Primary outcome [1] 342040 0
Total number of fruit serves per day over 6-month period with a standard portion size provided for each food item and determined using ‘natural’ serving size (eg. piece of fruit) where possible
Timepoint [1] 342040 0
Cross-sectional survey measured at a single timepoint
Primary outcome [2] 340534 0
Total number of both fruit and vegetable serves per day over 6-month period with a standard portion size provided for each food item and determined using ‘natural’ serving size (eg. piece of fruit) where possible
Timepoint [2] 340534 0
Cross-sectional survey measured at a single timepoint
Primary outcome [3] 342041 0
Total number of vegetable serves per day over 6-month period with a standard portion size provided for each food item and determined using ‘natural’ serving size (eg. piece of fruit) where possible
Timepoint [3] 342041 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [1] 449393 0
Magnesium intake (mg/day), average daily intake over 6 months
Timepoint [1] 449393 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [2] 449385 0
Vitamin A intake (µg/day), average daily intake over 6 months
Timepoint [2] 449385 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [3] 444365 0
Daytime sleepiness
Timepoint [3] 444365 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [4] 449386 0
Folate intake (µg/day), average daily intake over 6 months
Timepoint [4] 449386 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [5] 444359 0
Health related quality of life
Timepoint [5] 444359 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [6] 449391 0
Iodine intake (µg/day), average daily intake over 6 months
Timepoint [6] 449391 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [7] 449397 0
Potassium intake (mg/day), average daily intake over 6 months
Timepoint [7] 449397 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [8] 444363 0
Depression
Timepoint [8] 444363 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [9] 444361 0
Degree of disability caused by breathlessness in daily activities
Timepoint [9] 444361 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [10] 444357 0
Dietary fibre intake (average grams per day over 6 month period)
Timepoint [10] 444357 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [11] 445779 0
Food insecurity and access to adequate food over 12 month period
Timepoint [11] 445779 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [12] 445777 0
Symptoms of chronic fatigue
Timepoint [12] 445777 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [13] 444360 0
Health status of people with COPD
Timepoint [13] 444360 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [14] 449390 0
Calcium intake (mg/day), average daily intake over 6 months
Timepoint [14] 449390 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [15] 449673 0
Sitting time: Reported as minutes per day spent sitting
Timepoint [15] 449673 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [16] 445778 0
Appetite
Timepoint [16] 445778 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [17] 449671 0
Moderate physical activity: calculated as MET-minutes/week from moderate-intensity activity
Timepoint [17] 449671 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [18] 445780 0
Barriers to fruit and vegetable consumption
Timepoint [18] 445780 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [19] 449384 0
Vitamin C intake (mg/day), average daily intake over 6 months
Timepoint [19] 449384 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [20] 449392 0
Iron intake (mg/day), average daily intake over 6 months
Timepoint [20] 449392 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [21] 444364 0
Anxiety
Timepoint [21] 444364 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [22] 449383 0
Sedentary behaviour: average daily sitting time (minutes/day)
Timepoint [22] 449383 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [23] 449387 0
Niacin intake (mg/day), average daily intake over 6 months
Timepoint [23] 449387 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [24] 449672 0
Total time spent walking: calculated as total MET-minutes/week from time spent walking
Timepoint [24] 449672 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [25] 449396 0
Phosphorus intake (mg/day), average daily intake over 6 months
Timepoint [25] 449396 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [26] 449399 0
Zinc intake (mg/day), average daily intake over 6 months
Timepoint [26] 449399 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [27] 449398 0
Sodium intake (mg/day), average daily intake over 6 months
Timepoint [27] 449398 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [28] 449669 0
Total physical activity: calculated as total MET-minutes/week from vigorous, moderate, and walking activity
Timepoint [28] 449669 0
Cross-sectional survey measured at a single timepoint
Secondary outcome [29] 449670 0
Vigorous physical activity: calculated as MET-minutes/week from vigorous-intensity activity
Timepoint [29] 449670 0
Cross-sectional survey measured at a single timepoint

Eligibility
Key inclusion criteria
Group 1 (COPD group) (n=75)
1. Adults 40+ with a physician diagnosis of COPD as the primary respiratory diagnosis

Group 2 (Healthy controls) (n=75)
1. Adults 40+ with no respiratory disease
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Group 1 (COPD group)
1. Respiratory condition other than COPD as the primary respiratory diagnosis (e.g. asthma, lung cancer, interstitial lung disease, non-COPD bronchiectasis).
2. No COPD exacerbation, oral corticosteroid burst or antibiotic use for a COPD exacerbation in the previous four weeks
3, Pregnancy or breastfeeding

Group 2 (Healthy controls)
1. Any respiratory disease.
2. Pregnancy or breastfeeding

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis: Statistical analysis will be conducted to determine the impact of having COPD on fruit and vegetable intake and other clinical outcomes. Data will be summarised as mean and standard deviation, or median and inter-quartile range (IQR) if skewed. Categorical variables will be summarised as frequency count and percentage. Group comparisons for continuous data (e.g., fruit and vegetable score, fibre and antioxidant intake/day) will be performed using two sample t-testing. Dietary intake of fruits and vegetables will also be correlated with clinical measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318254 0
University
Name [1] 318254 0
The University of Newcastle Research Training Program (RTP) Scholarship
Country [1] 318254 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 320691 0
None
Name [1] 320691 0
Address [1] 320691 0
Country [1] 320691 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316895 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 316895 0
Ethics committee country [1] 316895 0
Australia
Date submitted for ethics approval [1] 316895 0
02/05/2025
Approval date [1] 316895 0
Ethics approval number [1] 316895 0

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

Contacts
Principal investigator
Name 139350 0
Dr Hayley Scott
Address 139350 0
Level 2, Hunter Medical Research Institute Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 139350 0
Australia
Phone 139350 0
+61 2 4042 0113
Fax 139350 0
Email 139350 0
[email protected]
Contact person for public queries
Name 139351 0
Rhiannon Stent
Address 139351 0
Level 2, Hunter Medical Research Institute Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 139351 0
Australia
Phone 139351 0
+61 2 4042 0978
Fax 139351 0
Email 139351 0
[email protected]
Contact person for scientific queries
Name 139352 0
Rhiannon Stent
Address 139352 0
Immune Health Research Program, The University of Newcastle Level 2, Hunter Medical Research Institute Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 139352 0
Australia
Phone 139352 0
+61 2 4042 0978
Fax 139352 0
Email 139352 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.