Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000476235
Ethics application status
Approved
Date submitted
23/02/2018
Date registered
3/04/2018
Date last updated
1/11/2019
Date data sharing statement initially provided
1/11/2019
Date results information initially provided
1/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Tu Ora - 1 Bar a Day for Diabetes Prevention
Scientific title
1 Bar a Day for Diabetes Prevention: a randomised controlled trial to investigate the effect of daily consumption of a healthy snack bar on the glycaemia of overweight and pre-diabetic Asian Chinese adults, resident in New Zealand.
Secondary ID [1] 293857 0
None
Universal Trial Number (UTN)
U1111-1208-3449
Trial acronym
1BarDDP
Linked study record
ACTRN12616000362493

Health condition
Health condition(s) or problem(s) studied:
Obesity 306319 0
Metabolic disease (prediabetes) 306320 0
Condition category
Condition code
Diet and Nutrition 305398 305398 0 0
Obesity
Metabolic and Endocrine 305399 305399 0 0
Metabolic disorders
Metabolic and Endocrine 305912 305912 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a 2arm randomised controlled trial of parallel design. A total of 112 Asian Chinese participants who are overweight and have prediabetes will be recruited from the wider Auckland and Wellington regions from March 2018. Eligible participants will be stratified by sex, age and BMI, and randomized either to a) a higher protein/ higher fat (good fat) bar or b) a lower protein, lower fat bar and matched for energy content. Participants will be instructed to consume their food prescription (1 bar/day) for 5 days/wk for 3 months as a meal or snack replacement, not as a dietary addition. The bars will be matched for energy (approx. 1000 kJ). The test bar will have approx. 6.4%En protein, 66.3%En fat (only 3.8%En saturated fat) and 29%En carbohydrate; the control bar will have approx. 4.6%En protein, 26.7En% fat (only 2.2%En saturated fat) and 64.4%En carbohydrate. Both groups will receive healthy eating advice at weeks 0 (60min duration) and weeks 2, 4, 8, 12 (30min duration each), based on the China Medical Nutrition Therapy Guideline for Diabetes (2013) (Chinese Diabetes Society 2015) recommendations. Participants will attend a screening visit at week -1 and 5 clinical investigation days (CIDs) at the Human Nutrition Unit in Auckland or Centre for Endocrine, Diabetes and Obesity Research (CEDOR) in Wellington, at baseline (week 0), and weeks 2, 4, 8, and 12 of the study. During CIDs, anthropometric data, biological samples and subjective data (questionnaires) will be collected to access the impact of the diets on metabolic health. Adherence will be assessed through the completion of 4-day food records, the number of packages returned from the trial bars and through assessment of specific lipids in blood samples, collected from participants during the visits. At each CID (week 0, 2, 4, 8 and 12) participants will have a 60min (week o) or 30min (weeks 2, 4, 8 and 12) healthy eating session with the dietitian. Postprandial glycaemic responses of the bars and the bars + a typical carbohydrate rich food (white bread) will be analysed acutely at the Auckland Centre only.
Intervention code [1] 300116 0
Prevention
Intervention code [2] 300464 0
Treatment: Other
Comparator / control treatment
The control arm is an active control, consuming a lower fat/ lower protein bar 5x/week as a meal or snack replacement. The bar consumed by the control group is, however, matched for energy content
Control group
Active

Outcomes
Primary outcome [1] 304539 0
Differences in fasting plasma glucose (mmol/L) between the 2 groups (higher protein/higher good fat and lower protein/lower fat)
Timepoint [1] 304539 0
at weeks -1, 2, 4, 8, and 12 (primary timepoint) of the intervention
Primary outcome [2] 304949 0
Differences in plasma glucose (mmol/L) between the 2 groups (higher protein/higher good fat and lower protein/lower fat), following a 2h oral glucose tolerance test
Timepoint [2] 304949 0
at weeks -1 and 12 of the intervention
Primary outcome [3] 321853 0
acute/postprandial plasma glucose response (area under the curve, AUC) of a higher protein nut-based snack bar when compared to an iso-energetic higher carbohydrate (CHO) cereal-based snack bar, with or without white bread (50g available CHO)
Timepoint [3] 321853 0
measured over the 2 hours following the test food consumption, at 15, 30, 45, 60, 75, 90, 105, and 120 minutes.
Secondary outcome [1] 342298 0
Differences in fasting insulin in mU/L between the 2 groups (higher protein/higher good fat and lower protein/lower fat)
Timepoint [1] 342298 0
at weeks -1 and 12 of the intervention
Secondary outcome [2] 342299 0
Differences in HbA1c in mmol/mol between the 2 groups (higher protein/higher good fat and lower protein/lower fat)
Timepoint [2] 342299 0
at weeks -1 and 12 of the intervention
Secondary outcome [3] 342301 0
Differences in 2h insulin in mmol/L, between the 2 groups (higher protein/higher good fat and lower protein/lower fat), following an oral glucose tolerance test
Timepoint [3] 342301 0
at weeks -1 and 12 of the intervention
Secondary outcome [4] 342302 0
Differences in the Matsuda index between the 2 groups (higher protein/higher good fat and lower protein/lower fat), following an oral glucose tolerance test
Timepoint [4] 342302 0
at weeks -1 and 12 of the intervention
Secondary outcome [5] 342303 0
Differences in body weight (kg) between the 2 groups (higher protein/higher good fat and lower protein/lower fat)
Timepoint [5] 342303 0
at weeks -1, 2, 4, 8 and 12 of the intervention
Secondary outcome [6] 343739 0
Differences in body composition - fat content in kg and in %, fat free mass in kg and in % between the 2 groups (higher protein/higher good fat and lower protein/lower fat) assessed through Dual X ray Absorptiometry (DeXA) scan
Timepoint [6] 343739 0
at weeks -1 and 12 of the intervention
Secondary outcome [7] 343740 0
cross sectional analysis of ectopic fat distribution (liver and pancreas) as a % of total body fat, assessed using Magnetic Resonance Imaging (MRI)
Timepoint [7] 343740 0
before the intervention (single time point, week -1)
Secondary outcome [8] 344449 0
Homeostatic model of beta cell function and insulin resistance - HOMA-IR, calculated based on fasting glucose and fasting insulin, as follows: (fasting glucose × fasting insulin)/22.5: Insulin concentration is reported in µU/L and glucose in mmol/L.
Timepoint [8] 344449 0
At weeks -1 and 12 of the intervention
Secondary outcome [9] 344450 0
Macronutrient intake (composite outcome) - protein, carbohydrate, fat (including saturated fat intake) and fibre, in g and in % - assessed through analysis of 4 day food records
Timepoint [9] 344450 0
At weeks -1 and 12 of the intervention
Secondary outcome [10] 344451 0
Full lipid profile collected from fasting serum samples: total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides in mmol/l
Timepoint [10] 344451 0
At weeks -1 and 12 of the intervention
Secondary outcome [11] 344452 0
Gut peptides/appetite hormone profile, including glucagon-like peptide -1 (GLP-1), peptide YY (PYY) and cholecystokinin (CKK) collected from plasma in the fasting (time 0) and postprandial (times 30, 60, 90 and 120 following consumption of 75g of glucose) states
Timepoint [11] 344452 0
At weeks -1 and 12 of the intervention
Secondary outcome [12] 344822 0
Differences in body mass index (BMI, kg/m2) assessed through measured body weight (kg, using a calibrated electric scale) and height (m, using a calibrated stadiometer) between the 2 groups (higher protein/higher good fat and lower protein/lower fat)
Timepoint [12] 344822 0
At weeks -1, 2, 4, 8, and 12 of the intervention
Secondary outcome [13] 344823 0
Differences in the microbiome community (bacterial count) assessed through collection of a spot fecal sample
Timepoint [13] 344823 0
At weeks -1 and 12 of the intervention
Secondary outcome [14] 344824 0
Differences in markers of inflammation (composite outcome) - C reactive protein, CRP, TNF-alpha and IL-6 - assessed through standard ELISAs performed in serum samples
Timepoint [14] 344824 0
At weeks -1 and 12 of the intervention

Eligibility
Key inclusion criteria
a) male or female
b) Asian (Ethnic Chinese, incl. mainland China, Singapore, Malaysian, Hong Kong, Taiwan, plus Korea);both parents ethnicity confirmed
c) aged between 25 and 70 years;
d) BMI between 24-40kg/m2 (Asian)
e) FINDRISC equal or greater than 15 (optimal cut-off for higher efficiency and efficacy of recruitment (Silvestre, Jiang et al. 2017)
f) fasting plasma glucose between 5.6 and 6.9mmol/l (ADA)
g) healthy otherwise;
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) BMI <24 kg/m2 or BMI>40kg/m2;
b) recent body weight loss/gain >5%, within previous 3 months;
c) type 1 or type 2 diabetes
d) significant CVD including current angina; myocardial infarction or stroke within past 6 months; heart failure; symptomatic peripheral vascular disease; SBP >160 mmHg and/or DBP >100 mmHg (with or without hypertensive medication)
e) major food allergy (e.g. allergy to nuts)

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 concealed - done centrally using a computer system
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
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
Power calculation for a single ethnicity Asian Chinese cohort was based on the assumption of an effect size of 0.3mmol/L of fasting plasma glucose with an SD of 0.97mmol/L for a significance of P<0.05 and statistical power of 80% (a = 0.05, 1-ß = 0.8). According to power calculations and an estimated 10% dropout rate, a sample size of 56 subjects per group is required (n=112 individuals in total).

Repeat measures ANOVA/linear mixed models will be used to compare change in outcome variables over time between the test and control product. Effects of variables including study site and gender will be included in the model. Primary outcome variables will be analysed both as intention to treat (ITT) and completers only. Statistical significance for p<0,05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/05/2018
Actual
19/04/2018
Date of last participant enrolment
Anticipated
21/09/2018
Actual
20/11/2018
Date of last data collection
Anticipated
21/12/2018
Actual
1/03/2019
Sample size
Target
112
Accrual to date
Final
103
Recruitment outside Australia
Country [1] 9518 0
New Zealand
State/province [1] 9518 0
Auckland
Country [2] 9519 0
New Zealand
State/province [2] 9519 0
Wellington

Funding & Sponsors
Funding source category [1] 298478 0
Government body
Name [1] 298478 0
Ministry of Business, Innovation and Employment - National Science Challenge, High Value Nutrition
Country [1] 298478 0
New Zealand
Primary sponsor type
University
Name
University of Auckland - Research Office
Address
Level 10, building 620
49 Symonds Street
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 297619 0
None
Name [1] 297619 0
Address [1] 297619 0
Country [1] 297619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299464 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 299464 0
Ministry of Health
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 299464 0
New Zealand
Date submitted for ethics approval [1] 299464 0
31/01/2018
Approval date [1] 299464 0
13/03/2018
Ethics approval number [1] 299464 0

Summary
Brief summary
This project is funded by NZ National Science Challenge, High Value Nutrition(HVN)program. HVN investigates metabolic health in Asian populations, with main focus on Asian Chinese. Objectives: The objective of this study is to improve metabolic health, including glycaemic control, in a cohort of overweight prediabetic Asian Chinese adults, randomised to 3 month meal or snack replacement intervention with a high protein, high (good) fat product or an energy equivalent lower protein, low fat product. Methods: A total of 112 Asian Chinese participants who are overweight and have prediabetes, as defined by impaired fasting glucose (IFG), will be recruited at 2 study sites from the wider Auckland and Wellington regions. Eligible participants will be randomized either to a) higher protein/ high fat (good fat) bar or b) lower protein/ low fat bar, The bars are matched for energy content. Participants will be instructed to consume their food prescription (1 bar/day) for 5 days/wk as a meal or snack replacement, not as a dietary addition. Participants will attend 5 clinical investigation days (CIDs) at baseline (week 0), and weeks 2, 4, 8, and 12 of the study. The primary outcomes will be fasting plasma glucose both; acutely (2h post meal) and over the 12 week period. Secondary outcomes will be body composition (fat distribution); fasting insulin; homeostatic model of insulin resistance (HOMA-IR; glycated haemoglobin (HbA1c); 2h glucose and insulin during an oral glucose tolerance test (OGTT) and metabolomics profile. Other outcomes will include microbiome community, energy and macronutrient intake, body weight and body mass index (BMI), lipid profile, appetite hormones (GLP-1, PYY, CCK) and markers of inflammation (C reactive protein - CRP -, TNF-alpha and IL-6).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80494 0
Prof Sally Poppitt
Address 80494 0
Human Nutrition Unit
18 Carrick Place, Mount Eden
1024 Auckland
Country 80494 0
New Zealand
Phone 80494 0
+64 (0)96301162
Fax 80494 0
Email 80494 0
[email protected]
Contact person for public queries
Name 80495 0
Dr Louise Lu
Address 80495 0
Human Nutrition Unit
18 Carrick Place, Mount Eden
1024 Auckland
Country 80495 0
New Zealand
Phone 80495 0
+64 (0)9 6305160
Fax 80495 0
Email 80495 0
[email protected]
Contact person for scientific queries
Name 80496 0
Dr Marta Silvestre
Address 80496 0
Human Nutrition Unit
18 Carrick Place, Mount Eden
1024 Auckland
Country 80496 0
New Zealand
Phone 80496 0
+64 (0)96301162
Fax 80496 0
Email 80496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Results from the acute and long term study
When will data be available (start and end dates)?
data will be available from December 2019 (estimated date for starting to publish the outputs). No end date determined
Available to whom?
To participants, individually, and to the science community through published articles sharing the trial results
Available for what types of analyses?
Available for consultation and citation only
How or where can data be obtained?
Through online scientific databases. Participants will receive a summary of their own results


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
EmbaseGut microbiota profiles in two New Zealand cohorts with overweight and prediabetes: a Tu Ora/PREVIEW comparative study.2023https://dx.doi.org/10.3389/fmicb.2023.1244179
N.B. These documents automatically identified may not have been verified by the study sponsor.