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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
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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.
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Secondary ID [1]
292227
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Poor diet
303731
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Cardiovascular disease
303732
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Condition category
Condition code
Diet and Nutrition
303104
303104
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0
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Other diet and nutrition disorders
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Neurological
303105
303105
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0
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Studies of the normal brain and nervous system
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Cardiovascular
303106
303106
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0
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Normal development and function of the cardiovascular system
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
298393
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Lifestyle
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Intervention code [2]
298394
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Prevention
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Intervention code [3]
298395
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in plasma carotenoid levels analysed using HPLC.
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Assessment method [1]
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Timepoint [1]
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Baseline and 4 weeks after intervention commencement
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Secondary outcome [1]
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Consumer Attitudes: Liking using a validated 9-point hedonic score
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Assessment method [1]
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Timepoint [1]
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Baseline, and week 1, 2, 3 and 4 after intervention commencement.
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Secondary outcome [2]
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Consumer Attitudes: Desire to consume product using a validated 7-point categorical scale
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Assessment method [2]
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Timepoint [2]
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Baseline, and week 1, 2, 3 and 4 after intervention commencement.
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Secondary outcome [3]
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Consumer Attitudes: Boredom using a validated visual analogue scale
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Assessment method [3]
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Timepoint [3]
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Week 1, 2, 3 and 4 after intervention commencement.
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Secondary outcome [4]
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Consumer attitudes: Effort to incorporate a new habit using an adapted question from the Self-Report Habit Index.
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Assessment method [4]
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Timepoint [4]
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Week 1, 2, 3 and 4 after intervention commencement.
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Secondary outcome [5]
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Consumer attitudes: Adherence to natural food using the validated sub-scale of Social representation theory scale.
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Assessment method [5]
336173
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Timepoint [5]
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Baseline and 4 weeks after study commencement.
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Secondary outcome [6]
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Consumer attitudes to inclusion of carrot-based processed foods assessed using a preference scale (fresh vs. processed) specifically designed for the study.
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Assessment method [6]
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Timepoint [6]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [7]
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Changes in buccal cell carotenoids
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Assessment method [7]
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Timepoint [7]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [8]
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Changes in colour and vascularity of the retina and macula using the Fundus Camera.
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Assessment method [8]
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Timepoint [8]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [9]
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Changes in cognitive function assessed using a battery of automated tasks delivered via the iPad: Reaction time (attention/psychomotor speed)
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Assessment method [9]
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Timepoint [9]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [10]
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Changes in cognitive function will be assessed using a battery of automated tasks delivered via the iPad: Coding (perceptual speed)
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Assessment method [10]
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Timepoint [10]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [11]
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Changes in cognitive function will be assessed using a battery of automated tasks delivered via the iPad: Digit Span (Working Memory)
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Assessment method [11]
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Timepoint [11]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [12]
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Changes in body composition assessed using Bioelectrical Impedance Analysis (BIA)
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Assessment method [12]
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Timepoint [12]
336183
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [13]
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Changes in fruit and vegetable intake and diet quality (composite secondary outcome) will be assessed using a validated online diet index score.
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Assessment method [13]
336184
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Timepoint [13]
336184
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Baseline and 4 weeks after intervention commenced.
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
17/07/2017
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Actual
7/08/2017
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Date of last participant enrolment
Anticipated
28/07/2017
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Actual
14/08/2017
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Date of last data collection
Anticipated
25/08/2017
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Actual
24/10/2017
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Sample size
Target
44
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Accrual to date
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Final
44
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment postcode(s) [1]
16472
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
296776
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Government body
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Name [1]
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Commonwealth Scientific Industrial Research Organisation
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Address [1]
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South Australian Health and Medical Research Institute building, North Terrace, Adelaide, South Australia,
5000
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Country [1]
296776
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Australia
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Primary sponsor type
Government body
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Name
Commonwealth Scientific Industrial Research Organisation
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Address
South Australian Health and Medical Research Institute building, North Terrace, Adelaide, South Australia,
5000
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Country
Australia
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Secondary sponsor category [1]
295757
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None
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Name [1]
295757
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Address [1]
295757
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Country [1]
295757
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297999
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CSIRO Health and Medical Research Human Research Ethics Committee
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Ethics committee address [1]
297999
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GPO Box 2583, Brisbane, Queensland, 4001, Australia
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Ethics committee country [1]
297999
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Australia
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Date submitted for ethics approval [1]
297999
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19/04/2017
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Approval date [1]
297999
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15/06/2017
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Ethics approval number [1]
297999
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6/2017
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Summary
Brief summary
People all over the world do not meet the recommended intake for fruit and vegetables. New strategies and options are needed to help people to boost their vegetable consumption. Carrots are an exceptional source of carotenoids, as well as fibre. Carotenoids are a precursor for vitamin A, one of the most common deficiencies worldwide, essential for eye health and may have various other health benefits through their antioxidant activity. The primary hypothesis of the study is that daily consumption of processed carrot powder added to foods is an effective, convenient and consumer accepted strategy to supplement vegetable intake, as shown by greater increases in carotenoid status after 4 weeks compared to daily consumption of carotenoid-rich vegetables.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Welma Stonehouse
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Address
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CSIRO
PO Box 10041, Adelaide, South Australia, 5000
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Country
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Australia
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Phone
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+61 8 8303 8919
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Welma Stonehouse
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Address
75691
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CSIRO
PO Box 10041, Adelaide, South Australia, 5000
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Country
75691
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Australia
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Phone
75691
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+61 8 8303 8919
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Fax
75691
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Email
75691
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[email protected]
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Contact person for scientific queries
Name
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Welma Stonehouse
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Address
75692
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CSIRO
PO Box 10041, Adelaide, South Australia, 5000
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Country
75692
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Australia
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Phone
75692
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+61 8 8303 8919
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Fax
75692
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Email
75692
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF