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Trial registered on ANZCTR


Registration number
ACTRN12620000353998
Ethics application status
Approved
Date submitted
26/02/2020
Date registered
12/03/2020
Date last updated
12/03/2020
Date data sharing statement initially provided
12/03/2020
Date results provided
12/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of lupin enriched biscuits as substitute mid-meal snacks on post-prandial interstitial glucose excursions in post-surgical hospital patients with type 2 diabetes
Scientific title
Continuous Glucose Monitoring to assess glycaemic excursions following mid-meal consumption of standard care hospital biscuits or Lupin-enriched biscuits: A pilot study in surgical patients with type 2 diabetes.
Secondary ID [1] 300660 0
Nill
Universal Trial Number (UTN)
Nill
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 316455 0
type 2 diabetes mellitus 316536 0
Condition category
Condition code
Metabolic and Endocrine 314780 314780 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Controlled cross-over intervention study that examined the effect of three different mid-meal snacks (i.e. biscuits) on glycaemic response in type 2 diabetes post-surgical patients.

Description of intervention: A controlled cross-over study design was followed, whereby all subjects received 3 different treatments on 3 consecutive days at morning and afternoon tea, approximately 10 am and 2 pm, respectively.
Recruitment commenced May 2018 and concluded December 2018. Post-surgery T2DM patients were asked to consume two biscuits at each morning tea and afternoon tea, in addition to a provided 45g carbohydrate-controlled meal at breakfast, lunch and dinner, for three consecutive days. The rationale for the 45 g quantity of carbohydrates in the main meals was that the hospital did not want to over-restrict patient food choices and it also wanted to be in line with the moderate carbohydrate intake recommended by the Agency for Clinical Innovation (New South Wales, Australia) for hospital patients with diabetes. On the first day, study participants were provided with four lupin biscuits (Skinnybik™ Lupin, Murrumbeena, Victoria, Australia) containing 20% lupin flour (equivalent to 1 tablespoon of lupin flour), on the second day with four wholemeal spelt biscuits (Skinnybik™ Spelt, Murrumbeena, Victoria, Australia) and on the third day with four hospital standard plain sweet biscuits (Arnott’s Marie Biscuits™, NSW, Australia). The lupin biscuit was provided first since it was expected to have the lowest impact on post-prandial glucose levels, therefore, less potential for carry-over effect of raised glucose levels. The pilot study was reviewed and approved by the Human Research Ethics Committee of La Trobe University (approval number HEC17-073), and permission to run the pilot study at Warringal Private Hospital was provided by the Director of Clinical Services. All participants involved provided informed written consent to participate. Continuous glucose monitoring (CGM) devices were fitted to each patient in the evening before commencing the 3-day diet intervention. Participants were instructed to refrain from consuming any extra snacks during the day and to not add sugar to tea or coffee.
In order to asses adherence, the Dietitian visited participants at meal and mid-meal times. For the three study days the amount of food and biscuits consumed by study participants in the main and mid-meals was estimated by the Dietitian through visual inspection. The amount of biscuits consumed, and plate wastage was taken into account when calculating the amount of carbohydrate consumed by study participants.
Intervention code [1] 316989 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323043 0
Interstitial glucose levels were assessed using Continuous Glucose Monitoring (CGM) technology as well as finger prick testing to calibrate CGM.
Timepoint [1] 323043 0
30 minutes before meal (baseline) and then 30 minutes, 45 minutes, 60 minutes, 75 minutes and 90 minutes postprandially.
Secondary outcome [1] 380609 0
Composite secondary outcomes were Satiety and palatability and were measured using a validated Likert scale tool.
Timepoint [1] 380609 0
On admission/pre-operative (baseline) and postoperative at day 1, day 2 and day, i.e. when each type of the three mid-meal snacks/biscuits were consumed.
Secondary outcome [2] 380610 0
Bowel motions (based on Bristol stool chart)
Timepoint [2] 380610 0
On admission/pre-operative (baseline) and postoperative at day 1, day 2 and day, i.e. when each type of the three mid-meal snacks/biscuits were consumed.

Eligibility
Key inclusion criteria
Twenty-five post-surgical hospital patients with type 2 diabetes mellitus (T2DM )were recruited for the study. The study participants were selected based on the following inclusion criteria: English speaking patients aged >50 years were eligible for study inclusion if they were diagnosed with T2DM, managing T2DM via oral hypoglycaemic agents and admitted for surgery.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded from the study if they had known allergies to wheat, eggs, nuts, legumes, corn and /or dairy, diagnosed Irritable Bowel Syndrome (IBS) or followed a low Fermentable Oligosaccharide Disaccharide Monosaccharide and Polyol (FODMAP) diet, diagnosed dementia or mental illness, non-English speaking or currently taking prescribed steroidal or insulin medications.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed, because it was not necessary based on the study design. In this regard, randomisation was not applied as each subject consumed identical treatment on each consecutive day.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable (see above)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Controlled cross-over study, whereby all subjects received 3 different treatments on 3 consecutive days at morning and afternoon tea, approximately 10 am and 2 pm, respectively.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data are reported as mean (standard deviation: SD or standard error: SE) or as frequencies and percentages (%). The chi-square test was used to assess the differences observed in hunger, fullness, palatability and bowel function scores among the three groups of participants. The Kolmogorov-Smirnov test was used to determine normality of distribution of the examined continuous variables. Differences with regards to the amount of biscuits consumed at each mid-meal were examined with the use of the non-parametric Kruskal-Wallis test. In addition, repeated measures analysis of variance (RM-ANOVA) was used to evaluate the significance of the differences between groups at pre-prandial and at 30, 45, 60, 75 and 90 minutes post-prandial (treatment effect), the significance of the changes observed within each group time effect) and the effect of Treatment x Time interaction. All statistical analyses were controlled for the amount of carbohydrates consumed at each meal, in order to compensate for the confounding effect that could be caused by the imbalance of carbohydrates intake on CGM levels. All P-values reported are two-tailed. Statistical analysis was conducted with the SPSS (version 24.0). The level of statistical significance was set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2018
Date of last participant enrolment
Anticipated
Actual
30/10/2018
Date of last data collection
Anticipated
Actual
2/11/2018
Sample size
Target
25
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16002 0
Warringal Private Hospital - Heidelberg
Recruitment postcode(s) [1] 29500 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 305083 0
University
Name [1] 305083 0
La Trobe University
Country [1] 305083 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Bundoora, VIC, 3086
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 305457 0
None
Name [1] 305457 0
Address [1] 305457 0
Country [1] 305457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305474 0
Human Research Ethics Committee of La Trobe University
Ethics committee address [1] 305474 0
Ethics committee country [1] 305474 0
Australia
Date submitted for ethics approval [1] 305474 0
05/06/2017
Approval date [1] 305474 0
01/09/2017
Ethics approval number [1] 305474 0
HEC17-073

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

Contacts
Principal investigator
Name 100494 0
A/Prof George Moschonis
Address 100494 0
Department of Dietetics, Nutrition and Sport
La Trobe University
Bundoora, VIC, 3086
AUSTRALIA
Country 100494 0
Australia
Phone 100494 0
+61 3 9479 9482
Fax 100494 0
Email 100494 0
g.moschonis@latrobe.edu.au
Contact person for public queries
Name 100495 0
Sophie Skalkos
Address 100495 0
Department of Dietetics, Nutrition and Sport
La Trobe University
Bundoora, VIC, 3086
AUSTRALIA
Country 100495 0
Australia
Phone 100495 0
+61 3 9479 9482
Fax 100495 0
Email 100495 0
foodwiseapd@optusnet.com.au
Contact person for scientific queries
Name 100496 0
Antigone Kouris-Blazos
Address 100496 0
Department of Dietetics, Nutrition and Sport
La Trobe University
Bundoora, VIC, 3086
AUSTRALIA
Country 100496 0
Australia
Phone 100496 0
+61 0408551702
Fax 100496 0
Email 100496 0
akouris@optusnet.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data
When will data be available (start and end dates)?
Start date: 01 February 2018; No end date determined
Available to whom?
Available to anyone upon request
Available for what types of analyses?
Any relevant analyses.
How or where can data be obtained?
by emailing the principal investigator (g.moschonis@latrobe.edu.au)


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
EmbaseEffect of lupin-enriched biscuits as substitute mid-meal snacks on post-prandial interstitial glucose excursions in post-surgical hospital patients with type 2 diabetes.2020https://dx.doi.org/10.3390/nu12051239
N.B. These documents automatically identified may not have been verified by the study sponsor.