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Trial registered on ANZCTR


Registration number
ACTRN12617000924358
Ethics application status
Approved
Date submitted
20/06/2017
Date registered
26/06/2017
Date last updated
16/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel processed carrot-based products to supplement vegetable intake in healthy adults
Scientific title
Investigating whether consumption of processed carrot powder is an effective strategy to supplement vegetable intake compared to fresh carotenoid-rich vegetables, as assessed by changes in plasma carotenoid levels in healthy adults.
Secondary ID [1] 292227 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor diet
 303731 0
Cardiovascular disease 303732 0
Condition category
Condition code
Diet and Nutrition 303104 303104 0 0
Other diet and nutrition disorders
Neurological 303105 303105 0 0
Studies of the normal brain and nervous system
Cardiovascular 303106 303106 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After 4 days of following a low carotenoid diet participants will consume 2 servings (2 tablespoons)/day of carrot powder added to suitable foods e.g. a broth style soup, pasta sauce, gravy, casserole, smoothie, yoghurt, juice etc in addition to usual vegetable intake for 4 weeks. The carrot powder will be provided to participants. Participants will receive detailed dietary instructions (developed in consultation with a dietitian), both orally and in writing, on how to follow the intervention. The amount of carrot powder is equivalent to 2 large carrots (2x72g carrot, also equivalent to 2 servings of vegetables). Participants will complete a daily checklist throughout the study to assess compliance to the intervention.
Intervention code [1] 298393 0
Lifestyle
Intervention code [2] 298394 0
Prevention
Intervention code [3] 298395 0
Treatment: Other
Comparator / control treatment
After 4 days of following a low carotenoid diet participants will consume 2 servings/day of fresh carotenoid-rich vegetables (e.g. carrots, tomatoes, broccoli, etc.) in addition to usual vegetable intake for 4 weeks. Participants will be given a voucher to purchase the vegetables themselves. Participants will receive detailed dietary instructions (developed in consultation with a dietitian), both orally and in writing, on how to follow the intervention. Participants will complete a daily checklist throughout the study to assess compliance to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 302489 0
Change in plasma carotenoid levels analysed using HPLC.
Timepoint [1] 302489 0
Baseline and 4 weeks after intervention commencement
Secondary outcome [1] 336169 0
Consumer Attitudes: Liking using a validated 9-point hedonic score
Timepoint [1] 336169 0
Baseline, and week 1, 2, 3 and 4 after intervention commencement.
Secondary outcome [2] 336170 0
Consumer Attitudes: Desire to consume product using a validated 7-point categorical scale
Timepoint [2] 336170 0
Baseline, and week 1, 2, 3 and 4 after intervention commencement.
Secondary outcome [3] 336171 0
Consumer Attitudes: Boredom using a validated visual analogue scale
Timepoint [3] 336171 0
Week 1, 2, 3 and 4 after intervention commencement.
Secondary outcome [4] 336172 0
Consumer attitudes: Effort to incorporate a new habit using an adapted question from the Self-Report Habit Index.
Timepoint [4] 336172 0
Week 1, 2, 3 and 4 after intervention commencement.
Secondary outcome [5] 336173 0
Consumer attitudes: Adherence to natural food using the validated sub-scale of Social representation theory scale.
Timepoint [5] 336173 0
Baseline and 4 weeks after study commencement.
Secondary outcome [6] 336174 0
Consumer attitudes to inclusion of carrot-based processed foods assessed using a preference scale (fresh vs. processed) specifically designed for the study.
Timepoint [6] 336174 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [7] 336177 0
Changes in buccal cell carotenoids
Timepoint [7] 336177 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [8] 336179 0
Changes in colour and vascularity of the retina and macula using the Fundus Camera.
Timepoint [8] 336179 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [9] 336180 0
Changes in cognitive function assessed using a battery of automated tasks delivered via the iPad: Reaction time (attention/psychomotor speed)
Timepoint [9] 336180 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [10] 336181 0
Changes in cognitive function will be assessed using a battery of automated tasks delivered via the iPad: Coding (perceptual speed)
Timepoint [10] 336181 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [11] 336182 0
Changes in cognitive function will be assessed using a battery of automated tasks delivered via the iPad: Digit Span (Working Memory)
Timepoint [11] 336182 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [12] 336183 0
Changes in body composition assessed using Bioelectrical Impedance Analysis (BIA)
Timepoint [12] 336183 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [13] 336184 0
Changes in fruit and vegetable intake and diet quality (composite secondary outcome) will be assessed using a validated online diet index score.
Timepoint [13] 336184 0
Baseline and 4 weeks after intervention commenced.

Eligibility
Key inclusion criteria
1. Healthy Male or Female adults
2. BMI between 18.5-30 kg/m2
3. Blood pressure <140/90 mmHg
4. Understand study and agree to participate
5. Adhere closely to the prescribed food consumption as per the research protocol
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of chronic disease, e.g. type 2 diabetes, heart disease, cancer, atherosclerotic disease, hypertension, stomach ulcers, drug abuse or alcoholism
2. History of pancreatic insufficiency or other conditions resulting in fat malabsorption - chronic pancreatitis, cystic fibrosis, coeliac disease, crohns disease, gastric bypass surgery, small bowel resection, abnormal thyroid function
3. History of smoking during 6 months prior to study
4. Extended absences due to travel or other commitments
5. Known allergy to the test foods, and anyone with severe food allergies - even in trace amounts.
6. Pregnancy or breastfeeding
7. Medication or nutritional supplements that may affect the study outcomes
8. On any weight-loss programs

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation of eligible participants will be conducted by a different person than the person who decides that a participant is eligible for inclusion in the trial. Hence the person who makes decisions regarding eligibility will not be aware at the time and have no influence over which groups participant's are allocated too.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be assigned to the interventions using stratified random assignment based on sex and age. The randomization scheme will be computer generated.
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
Based on previous data from our laboratory 20 participants per group (total n=40) will provide 80% power (two-tailed, a=0.05) to detect a mean difference of 0.6 µg/mL in total plasma carotenoids (assuming a 2x greater efficiency of carrot powder to increase plasma carotenoid concentrations compared to fresh vegetables), using a SD of change of 0.67 µg/mL. A total of 44 participants will be recruited to account for a 10% dropout. A greater dropout is not expected due to the short duration (4 weeks) of the trial.
Main intervention effects (differences between groups) will be assessed using Independent Samples T-test, Mann-Whitney U tests and chi-square tests for parametric, non-parametric and categorical data, respectively using IBM SPSS statistics for WINDOWS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2017
Actual
7/08/2017
Date of last participant enrolment
Anticipated
28/07/2017
Actual
14/08/2017
Date of last data collection
Anticipated
25/08/2017
Actual
24/10/2017
Sample size
Target
44
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 16472 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296776 0
Government body
Name [1] 296776 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 296776 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation
Address
South Australian Health and Medical Research Institute building, North Terrace, Adelaide, South Australia,
5000
Country
Australia
Secondary sponsor category [1] 295757 0
None
Name [1] 295757 0
Address [1] 295757 0
Country [1] 295757 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297999 0
CSIRO Health and Medical Research Human Research Ethics Committee
Ethics committee address [1] 297999 0
Ethics committee country [1] 297999 0
Australia
Date submitted for ethics approval [1] 297999 0
19/04/2017
Approval date [1] 297999 0
15/06/2017
Ethics approval number [1] 297999 0
6/2017

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

Contacts
Principal investigator
Name 75690 0
Dr Welma Stonehouse
Address 75690 0
CSIRO
PO Box 10041, Adelaide, South Australia, 5000
Country 75690 0
Australia
Phone 75690 0
+61 8 8303 8919
Fax 75690 0
Email 75690 0
welma.stonehouse@csiro.au
Contact person for public queries
Name 75691 0
Welma Stonehouse
Address 75691 0
CSIRO
PO Box 10041, Adelaide, South Australia, 5000
Country 75691 0
Australia
Phone 75691 0
+61 8 8303 8919
Fax 75691 0
Email 75691 0
welma.stonehouse@csiro.au
Contact person for scientific queries
Name 75692 0
Welma Stonehouse
Address 75692 0
CSIRO
PO Box 10041, Adelaide, South Australia, 5000
Country 75692 0
Australia
Phone 75692 0
+61 8 8303 8919
Fax 75692 0
Email 75692 0
welma.stonehouse@csiro.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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