Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000210774
Ethics application status
Approved
Date submitted
27/01/2022
Date registered
7/02/2022
Date last updated
29/10/2024
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating FEijoa foR DIabetes Prevention in a Multi-ethnic New ZeAlaND Cohort: the FERDINAND study. A community nutrition intervention in individuals with pre-diabetes.
Scientific title
Evaluating FEijoa foR DIabetes Prevention in a Multi-ethnic New ZeAlaND Cohort: the FERDINAND study. A community nutrition intervention in individuals with pre-diabetes.
Secondary ID [1] 306221 0
None
Universal Trial Number (UTN)
U1111-1273-1316
Trial acronym
FERDINAND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 324943 0
Condition category
Condition code
Metabolic and Endocrine 322373 322373 0 0
Diabetes
Diet and Nutrition 322374 322374 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The FERDINAND study is a 2 arm, parallel design, double blind randomised control trial conducted in 160 participants (n=80 per intervention group). The dietary intervention will span 6 months, consisting of an initial acute 2-month weight-loss phase driven by low energy diet (LED; Phase 1) and followed by a longer-term 4-month weight loss maintenance phase (Phase 2) using dietary advice which adheres to the NZ Ministry of Health Guidelines.
The 2 intervention arms are as follows:
1. Healthy diet/weight loss advice + feijoa whole fruit powder (n=80)
Total meal replacement during the LED phase only [e.g. clinical investigation day (CID) 1 - CID 2], 4MJ/day; 1150 mg/d feijoa whole fruit powder daily in both phase 1 and phase 2 (to be consumed daily, with breakfast meal)
2. Healthy diet/weight loss advice + matched Placebo (n=80)
Total meal replacement during the LED phase only [CID 1- CID 2], 4MJ/day; 1150 mg/d matched placebo (e.g. bland non active commercial placebo like microcrystalline cellulose) daily in both phase 1 and phase 2 (to be consumed daily, with breakfast meal).

Participants will be randomised to either of the two study arms, and will be required to adhere to the dietary advice provided by research staff/dietitians. They will be provided
with all LED (as Cambridge Weight Plan sachets) + powder during the first 2 mths of the study. LED is energy restricted with a target intake of ~4MJ/day. The target macronutrient composition of the diet will be 15-20% of total energy from fat, 35-40% from protein and
45-50% from carbohydrate. LED products include shakes, soups, bars, porridge, pasta and savoury meals. Participants will be supported throughout the first two months of the LED phase, either in person or via virtual online mHealth platform, at 5 group meetings delivered from the HNU clinic site. All LED sachets will be provided free of charge to the participants. During the subsequent 4 month weight maintenance phase 2 of the study, they continue to receive the powder and will additionally receive dietary advice following best practice New Zealand Ministry of Health healthy eating guidelines for improving metabolic health, with diet advice provided by dietitians. These meetings will be either in person or via virtual mHealth platform; at 4 group meetings delivered from the research site.

There will be a total of 9 clinic visits and group diet advice (which will be a combination of
in person or via virtual mHealth platform conducted by dietitians throughout the intervention, to provide dietary advice and support to maximise compliance and treatment success). Group diet advice sessions (~1-2 hours) are as follows: In person visits: week: 0, 8 (Phase 1, LED); and month 4, 6 (Phase 2, maintenance). Virtual visits: week 2,4,6 (Phase 1, LED) and month 3,5 (Phase 2, maintenance).
Within each diet intervention arm, a sub group of participants will be randomised to undergo further additional repeated assessments (i.e. magnetic resonance imaging and spectroscopy, oral glucose tolerance test and indirect calorimetry) at CID 1 and follow up CID 2, and CID 4.
Compliance will be monitored over the intervention period from nitrogen balance, based on 24-hr urine collection.
Intervention code [1] 322624 0
Prevention
Comparator / control treatment
The placebo will be a matched powder (e.g. bland non active commercial placebo like microcrystalline cellulose).
Participants randomised to the control arm will receive the LED meal replacement during LED phase 1 and will be given dietary advice based on healthy eating guidelines specified by the New Zealand Ministry of Health (Ministry of Health, 2015).
Control group
Placebo

Outcomes
Primary outcome [1] 330141 0
Measure change in fasting plasma glucose
Timepoint [1] 330141 0
In all participants at Baseline (month 0), month 2 (end of LED phase), month 4 (mid way through weight maintenance phase), month 6 (end of study)
Primary outcome [2] 330142 0
Change in body weight (using digital scales)
Timepoint [2] 330142 0
In all participants at Baseline (month 0), month 2 (end of LED phase), month 4 (mid way through weight maintenance phase), month 6 (end of study)
Secondary outcome [1] 405032 0
Change in blood glycosylated haemoglobin (HbA1c)
Timepoint [1] 405032 0
In all participants at Baseline (month 0), month 2 (end of LED phase), month 4 (mid way through weight maintenance phase), month 6 (end of study)
Secondary outcome [2] 405033 0
Composite change in postprandial glucose following both:
- mixed meal tests (MMT) at home using continuous glucose monitor (CGM)
- oral glucose tolerance test (OGTT), using 75g glucose drink, at the Human Nutrition Unit clinic
Timepoint [2] 405033 0
MMT: conducted over 3 consecutive days prior to the start of the study clinic visit [baseline (month 0)] in all participants and prior to the end of the study clinic visit [month 6] in a subgroup; n=40 placebo + n=40 whole fruit powder intervention arm. OGTT conducted over 2 hr at baseline (month 0) in all participants; at month 2 (end of LED phase 1) in subgroup; n=40 placebo + n=40 whole fruit powder intervention arm; and at month 6 (end of the study) in subgroup; n=40 placebo + n=40 whole fruit powder intervention arm. During OGTT: 7.42 - 7.45am: t=0 min, fasted blood sample 8 - 9.30am: blood sample every 15 min, t=15min to t=90 min 9.45am : final blood sample t=120min,
Secondary outcome [3] 405080 0
Change in body composition using whole body dual energy x-ray absorptiometry (DeXA) and ectopic organ fat using magnetic resonance imaging and spectroscopy (MRI/S).
Timepoint [3] 405080 0
DeXA: In all participants at Baseline (month 0), month 2 (end of LED phase 1), month 4 (mid way through weight maintenance Phase 2), month 6 (end of the study) MRI/S: In a subgroup (n=15 placebo + n=15 whole fruit powder arm) at Baseline (month 0), month 2 (end of LED phase 1) and month 6 (end of the study)
Secondary outcome [4] 405081 0
Change in plasma metabolome
Timepoint [4] 405081 0
In all participants at Baseline (month 0), month 2 (end of LED phase 1), month 4 (mid way through weight maintenance Phase 2), month 6 (end of the study)
Secondary outcome [5] 405384 0
Composite change in basal metabolic rate (BMR) and post prandial energy expenditure (glucose induced thermogenesis, GIT) assessed using indirect calorimetry
Timepoint [5] 405384 0
BMR: will be tested fasted for 30 min at Baseline (month 0) in a sub group of participants; (n=15 placebo + n=15 whole fruit powder intervention arm) and at month 2 (end of LED phase 1) and month 6 (end of the study). GIT: will be tested at Baseline (month 0), at month 2 (end of LED phase 1) and month 6 (end of the study) in this subgroup; during the 75g oral glucose tolerance test (OGTT) 7.42 - 7.45am: t=0 min, fasted blood sample 8 - 9.30am: blood sample every 15 min, t=15min to t=90 min 9.45am: final blood sample t=120min,
Secondary outcome [6] 405387 0
Change in blood clinical markers of obesity and type 2 diabetes
The markers include:
• fasting and post prandial OGTT insulin
• C-peptide
• lipid profile (TC, LDL-C, HDL-C, TAG)
• liver function enzymes
• inflammatory markers and PBMCs for immune profiling
• T2D related peptides, including adiponectin, amylin, glucagon, GLP-1
• epigenetic, SNP, miRNA markers of T2D
Timepoint [6] 405387 0
In all participants at Baseline (month 0), month 2 (end of LED phase 1), month 4 (mid way through weight maintenance Phase 2), month 6 (end of the study)
Secondary outcome [7] 405388 0
Change in physical activity using step count
Timepoint [7] 405388 0
In all participants at Baseline (month 0), month 2 (end of LED phase 1), month 4 (mid way through weight maintenance Phase 2), month 6 (end of the study)
Secondary outcome [8] 405389 0
Change in Feacal microbiome
Timepoint [8] 405389 0
In all participants at Baseline (month 0), month 2 (end of LED phase 1), and month 6 (end of the study)
Secondary outcome [9] 405390 0
Change in 24-hr glycaemic variability from CGM (e.g. evaluated using matrices such as standard deviation, SD; mean amplitude of glycaemic excursion, MAGE; mean of daily difference for inter-day variation, MODD; continuous overlapping net glycaemic action, CONGA)
Timepoint [9] 405390 0
Data collected during MMTs; conducted over 3 consecutive days prior to the start of the study clinic visit [baseline (m0)] in all participants and prior to the end of the study clinic visit [m6] in a subgroup; n=40 placebo + n=40 whole fruit powder intervention arm.
Secondary outcome [10] 405700 0
Change in regulation of the aryl hydrocarbon receptor (AhR) activity in blood and feces
Timepoint [10] 405700 0
In all participants at Baseline (month 0), month 2 (end of LED phase 1), and month 6 (end of the study)

Eligibility
Key inclusion criteria
• Male and female
• Aged between 18 - 70 years
• BMI greater than or equal to 26 kg/m2 and body weight less than or equal to 150kg
• Fasting plasma glucose (FPG) in prediabetic range, 5.6 – 6.9 mmol/L
• Otherwise healthy, as per self-report
• Agreement to participate in a weight loss study
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Type 1 or type 2 diabetes mellitus
• Medications controlling glycaemia
• Current or history of significant disease including cardiovascular disease; pancreatic disease, or other digestive diseases including inflammatory bowel syndrome/disease, ulcerative colitis, Crohn's disease; cancer; plus associated medications including steroids (except topical steroids) and atypical antipsychotics
• Recent body weight loss/gain > 10 % within previous 3 months or taking part in an active diet program; or current medications for weight loss; or intending to alter physical activity during following 12 months
• Previous bariatric surgery
• Smoker or vaper, current or in previous 6 months
• Recreational drug user, current or in previous 6 months
• Pregnant or breastfeeding women, current or in previous 6 months
• Dislike or unwilling to consume food items included in the study (including animal products), or hypersensitivities or allergies to these foods
• Unwilling/unable to comply with study protocol
• Participation in other clinical intervention study, current or in previous 6 months
• Considered unsuitable to participate by the PI

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)
Allocation is not concealed to the investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be blinded to whether they will be receiving the whole fruit powder or the matched placebo powder. All participants will be randomised by chance to either study intervention arm so that responses and differences in the diabetes biomarker profile can be tested.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori modelling of sample size was conducted using change in FPG data obtained from the New Zealand arm of the PREVIEW study (Fogelholm et al., 2017), conducted in a cohort of overweight adults with prediabetes and of mixed ethnicity at the HNU, University of Auckland and similar cohorts in LED weight loss trials such as the DROPLET (Astbury et al., 2018) and & DioGenes responder subgroup (Valsesia, Saris, Astrup, Hager, & Masoodi, 2016).
The sample size calculations are based on the assumption that the improvement in FPG achieved during 2 month LED weight loss (Phase 1) will be maintained between control and treatment groups during the following weight loss maintenance (Phase 2).

With a sample of 160 (80 per group) in a 2 arm, parallel design longitudinal study, baseline FPG 5.8 mmol/L (0.6 mmol/L SD), type I error a = 0.05, power of 80%, and drop out of 20%, we can detect a between-treatment difference in FPG of 0.3 mmol/L. This is both a statistically and clinically significant difference. The estimates show that N = 64 individuals per group are required, which is increased to N = 80 to account for up to 20% drop out rate during follow-up over the 8 mth period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/09/2022
Actual
13/09/2022
Date of last participant enrolment
Anticipated
Actual
29/08/2023
Date of last data collection
Anticipated
Actual
15/03/2024
Sample size
Target
160
Accrual to date
Final
97
Recruitment outside Australia
Country [1] 24508 0
New Zealand
State/province [1] 24508 0
Auckland

Funding & Sponsors
Funding source category [1] 310570 0
Government body
Name [1] 310570 0
New Zealand National Science Challenge High Value Nutrition Programme, New Zealand Ministry of Business, Innovation and Enterprise (MBIE)
Country [1] 310570 0
New Zealand
Primary sponsor type
University
Name
The university of Auckland
Address
Level 10, Building 620
49 Symonds St
Auckland 1010
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311747 0
None
Name [1] 311747 0
Address [1] 311747 0
Country [1] 311747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310177 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 310177 0
Ethics committee country [1] 310177 0
New Zealand
Date submitted for ethics approval [1] 310177 0
27/01/2022
Approval date [1] 310177 0
16/03/2022
Ethics approval number [1] 310177 0
2022 EXP 12032

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

Contacts
Principal investigator
Name 116762 0
A/Prof Jennifer Miles-Chan
Address 116762 0
University of Auckland
Human Nutrition Unit,
18 Carrik Place, Mt Eden, Auckland 1024
Country 116762 0
New Zealand
Phone 116762 0
+64 9 923 4322
Fax 116762 0
Email 116762 0
[email protected]
Contact person for public queries
Name 116763 0
Ivana R Sequeira
Address 116763 0
University of Auckland
Human Nutrition Unit,
18 Carrick Place, Mt Eden, Auckland 1024
Country 116763 0
New Zealand
Phone 116763 0
+64 09 6301162
Fax 116763 0
Email 116763 0
[email protected]
Contact person for scientific queries
Name 116764 0
Ivana R Sequeira
Address 116764 0
University of Auckland
Human Nutrition Unit,
18 Carrick Place, Mt Eden, Auckland 1024
Country 116764 0
New Zealand
Phone 116764 0
+64 09 6301162
Fax 116764 0
Email 116764 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
This is in accordance to National Health and Disabilities Ethics Committees application that all data generated will only be used for this study only. However, if this is necessary additional consent will be obtained from participants to allow the use of data for other studies.


What supporting documents are/will be available?




Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.