Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000046909
Ethics application status
Approved
Date submitted
18/12/2019
Date registered
22/01/2020
Date last updated
22/01/2020
Date data sharing statement initially provided
22/01/2020
Date results provided
22/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A fruit and vegetable rich diet for weight loss
Scientific title
A fruit and vegetable rich diet for weight loss in healthy, overweight volunteers
Secondary ID [1] 300131 0
HMRI 13-54
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 315657 0
Obesity 315781 0
Condition category
Condition code
Diet and Nutrition 313950 313950 0 0
Obesity
Inflammatory and Immune System 313951 313951 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 week pre-post study, containing total 5 sessions (2x baseline sessions containing 2x exercise sessions and 1x diet consult; 1x diet consult at week 2; and 2x follow up sessions at week 10 containing 2x exercise sessions).
To determine the effectiveness of an individualised, fruit and vegetable rich diet on weight loss and on the changes in markers of inflammation that occur in response to a bout of exercise.

Individualised fruit and vegetable rich diet: participants will receive 2x in-person consults (baseline and week 2) with an Accredited Practicing Dietitian for approximately 1 hour each to help participants identify where they can make changes to their diet, tips and diet resources on how to increase fruit and vegetable intakes. Diet resources included meal planning template, information on energy restrictions for weight loss, government departments including resources from The Dietitians Association of Australia, Nutrition Education Materials Online, Australian Healthy Food Guide. These resources provide general information on weight loss, improving overall diet and increasing fruit and vegetable intakes. Resources are provided at the baseline dietitian consult and participants are encouraged to use resources as needed for the study duration. Dietary feedback will be based on a report generated from the Australian Eating Survey (AES) food frequency questionnaire results which compares intake to national guidelines. The AES survey will be completed in baseline session of the study.
Participants at baseline are provided with a weeks worth (~49 serves) fruit and vegetables to demonstrate how much they should be consuming during the study. For the remaining 9 weeks participants are instructed to continue diet plan by supplying their own fruit and vegetables and are reimbursed with a $100 gift card at the conclusion of the study to cover additional costs of increasing fruit and vegetable intakes.
Participants instructed to incorporate recommended serves of fruits and vegetables into their diet for the 10 weeks of the intervention. Strategies and plans on how this could be achieved were discussed in sessions with the dietitian. Diet recalls and weight were collected at week 2 to assess adherence to the intervention initially and determine additional strategies that would help participants comply with the intervention for the remainder of the study.

Exercise: 2x exercise sessions will be held at baseline and another 2x exercise sessions at week 10. In the first exercise session participants will complete an aerobic fitness test on a treadmill (VO2max test, vigorous intensity assessed on VO2 output data) to determine their maximum aerobic fitness capacity (test goes for approximately 10-15mins), results from this test will be used to determine speed for interval session held approximately one week after the VO2max session. Total duration for the first exercise sessions approximately 1 hour. Interval sessions contained 6x3min intervals conducted on a treadmill with a 1.5min rest between each interval (approximately 30mins). Interval sessions are of vigorous intensity at 90% VO2max capacity, this is assessed using the Borg RPE scale. Total duration for second exercise sessions including the interval session go for approximately 2 hours. This session also included a dietitian consult.
Exercise sessions are supervised by a dietitian who is trained in performing exercise testing. Additional exercise science students and interns, who are also trained in performing the exercise tests, provide additional supervision/support during the exercise testing sessions. All sessions are completed individually in a one-on-one session. Participants encouraged to maintain normal physical activity routines for the duration of the study. International physical activity questionnaire undertaken at baseline and follow up to determine changes in physical activity levels and session attendance are used to monitor adherence to the intervention.

Inflammation: blood samples collected in interval sessions prior to interval test, initially after intervals completed and 1 hour post interval session.

Intervention code [1] 316403 0
Lifestyle
Intervention code [2] 316404 0
Behaviour
Intervention code [3] 316495 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322349 0
Change in inflammatory markers (IL-6, IL-1ra) collected from blood samples before and initially after and 1 hour after interval exercise testing.
Timepoint [1] 322349 0
Baseline and End of intervention (week 10)
Primary outcome [2] 322350 0
Change in weight (InBody 770 Body composition and body water analyser)
Timepoint [2] 322350 0
Baseline, Week 2 and End intervention (week 10 - primary endpoint)
Primary outcome [3] 322351 0
Change in fruit and vegetable intake - measured using both the Australian Eating Survey food frequency questionnaire and multiple 24 hour recalls via the Automated Self-Administered 24 hr recall system (ASA-24 Australia)
(NB: composite primary outcome)
Timepoint [3] 322351 0
Baseline, Week 2 and End of intervention (week 10 - primary endpoint)
Secondary outcome [1] 378173 0
Height - manual stadiometer
Timepoint [1] 378173 0
Baseline and End of intervention (week 10)
Secondary outcome [2] 378174 0
Change in body composition including composite change in fat mass, muscle mass, body fat percentage (InBody 770 Body composition and body water analyser)
Timepoint [2] 378174 0
Baseline and End of intervention (week 10)
Secondary outcome [3] 378175 0
Change in urinary diet biomarkers (polyphenols, metabolites)
(NB: exploratory outcome)
Timepoint [3] 378175 0
Baseline, Week 2 and end of intervention (week 10)
Secondary outcome [4] 378176 0
Change in waist circumference (measured by researcher using measuring tape half way between top of hip and bottom rib)
Timepoint [4] 378176 0
Baseline, Week 2 and end of intervention (week 10)
Secondary outcome [5] 378177 0
Change in skin colour reflectance - photographs were taken on the palm of the hand, and either side of the elbow using a spectrophotometer.
Timepoint [5] 378177 0
Baseline, Week 2 and end of intervention (week 10)
Secondary outcome [6] 378178 0
Change in resting metabolic rate - Cosmed K4b2
Timepoint [6] 378178 0
Baseline and End of intervention (week 10)
Secondary outcome [7] 378179 0
Change in VO2 max aerobic exercise capacity - assessed using VO2max test using Cosmed K4b2
Timepoint [7] 378179 0
Baseline and End of intervention (week 10)
Secondary outcome [8] 378180 0
Change in serum diet biomarkers (polyphenols)
Timepoint [8] 378180 0
Baseline and End of intervention (week 10)
Secondary outcome [9] 378181 0
Change in physical activity level (measured using the International Physical Activity Questionnaire short form)
Timepoint [9] 378181 0
Baseline and End of intervention (week 10)
Secondary outcome [10] 378182 0
Interval exercise training - ability to complete 6x3 min interval test at 90% VO2max with 1.5 min rests between each interval. Assessed using Borg RPE scale
Timepoint [10] 378182 0
Baseline and End of intervention
Secondary outcome [11] 378183 0
Change in overall dietary intake (measured using the Australian Eating Survey food frequency questionnaire and repeat 24 hr recalls completed using ASA-24 Australia
Timepoint [11] 378183 0
Baseline, Week 2 and End of intervention (Week 10)

Eligibility
Key inclusion criteria
Males and females aged 18-45 years
BMI >25 kg/m2 and <35kg/m2
Body far percentage >20% males, >30% females
Interested in losing weight
Willing to eat a high fruit and vegetable diet
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Type 1 diabetes
Asthma
Health conditions that may prevent them from changing diet or performing exercise tests safely
Pregnant or lactating
History or current eating disorder
Participating in additional weight loss programs/studies
Implanted electrical device e.g. pacemaker

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pre -post study - all participants received intervention at same time
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics, linear regressions, correlations, Kappa statistics

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/08/2017
Date of last participant enrolment
Anticipated
Actual
20/04/2018
Date of last data collection
Anticipated
Actual
13/07/2018
Sample size
Target
40
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 28897 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 28898 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 304569 0
Charities/Societies/Foundations
Name [1] 304569 0
Hunter Medical Research Institute, Lions District 201N3 Diabetes Foundation
Country [1] 304569 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, University of Newcastle, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 304851 0
University
Name [1] 304851 0
The University of Newcastle
Address [1] 304851 0
University Drive, University of Newcastle, Callaghan, NSW, 2308
Country [1] 304851 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304995 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 304995 0
Ethics committee country [1] 304995 0
Australia
Date submitted for ethics approval [1] 304995 0
31/03/2017
Approval date [1] 304995 0
08/08/2017
Ethics approval number [1] 304995 0
H-2013-0315

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

Contacts
Principal investigator
Name 98902 0
Prof Lisa Wood
Address 98902 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 98902 0
Australia
Phone 98902 0
+61 2 40420147
Fax 98902 0
Email 98902 0
[email protected]
Contact person for public queries
Name 98903 0
Lisa Wood
Address 98903 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 98903 0
Australia
Phone 98903 0
+61 2 40420147
Fax 98903 0
Email 98903 0
[email protected]
Contact person for scientific queries
Name 98904 0
Lisa Wood
Address 98904 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 98904 0
Australia
Phone 98904 0
+61 2 40420147
Fax 98904 0
Email 98904 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Do not have ethics approval to do this.


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
SourceTitleYear of PublicationDOI
EmbaseThe relationship between dietary polyphenol intakes and urinary polyphenol concentrations in adults prescribed a high vegetable and fruit diet.2020https://dx.doi.org/10.3390/nu12113431
N.B. These documents automatically identified may not have been verified by the study sponsor.