Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000689572p
Ethics application status
Submitted, not yet approved
Date submitted
15/05/2024
Date registered
30/05/2024
Date last updated
30/05/2024
Date data sharing statement initially provided
30/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Nut consumption patterns and 24-hour blood glucose regulation
Scientific title
Effects of nut consumption patterns on the 24-hour glucose homeostasis of adults with type 2 diabetes mellitus (T2DM): A pilot study
Secondary ID [1] 312153 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 333800 0
Condition category
Condition code
Metabolic and Endocrine 330471 330471 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a cross-over study and the study will last for 7 days in total as described below
Day 1 (research facility): Placement of CGM and accelerometer
Day 2 (free-living environment): Study Diet 1 (randomised)
Day 3 (free-living environment): Washout (habitual diet)
Day 4 (free-living environment): Study Diet 2 (randomised)
Day 5 (free-living environment): Washout (habitual diet)
Day 6 (free-living environment): Study Diet 3 (randomised)
Day 7 (research facility): Removal of CGM and accelerometer

This trial consists of 3 Study Diets, which includes a control (no nut) and two intervention diets, which are 1) ONE (1 preload of 42g whole almonds consumed with the first meal i.e. breakfast, and 2) PRE-M (14g whole almonds (total 42g) consumed with each of 3 main meals). Each Study Diet will last for 1 day (on Day 2, 4 and 6), with washout between Study Diets on Day 3 and 5.

As part of the study design and to enhance compliance, participants will be provided with all meals on Study Diet days (Day 2, 4 & 6), where meals and intervention foods (weighed whole almonds) will be packed and clearly labelled, so that the participants know when to consume these meals and almonds.
Intervention code [1] 328595 0
Treatment: Other
Comparator / control treatment
the control diet control (CTRL) will be usual diet without any nuts
Control group
Active

Outcomes
Primary outcome [1] 338244 0
Blood glucose levels
Timepoint [1] 338244 0
Continuously for 7 days, which include CGM placement (Day 1) and removal (Day 7) days, 3 test diets (Control, ONE and PRE-M, 1 day each on Day 2, 4 & 6), and washout between diets (Day 3 & 5).
Secondary outcome [1] 435118 0
Weight
Timepoint [1] 435118 0
Baseline and Day-7 post-baseline
Secondary outcome [2] 435119 0
Height
Timepoint [2] 435119 0
Baseline and Day-7 post-baseline
Secondary outcome [3] 435120 0
Body mass index
Timepoint [3] 435120 0
Baseline and Day-7 post-baseline
Secondary outcome [4] 435121 0
Body composition
Timepoint [4] 435121 0
Baseline and Day-7 post-baseline
Secondary outcome [5] 435122 0
Waist circumference
Timepoint [5] 435122 0
Baseline and Day-7 post-baseline
Secondary outcome [6] 435123 0
Blood pressure
Timepoint [6] 435123 0
Baseline and Day-7 post-baseline
Secondary outcome [7] 435124 0
Physical activity level
Timepoint [7] 435124 0
Continuously for 7 days, which include accelerometer placement (Day 1) and removal (Day 7) days, 3 test diets (Control, ONE and PRE-M, 1 day each on Day 2, 4 & 6), and washout between diets (Day 3 & 5).

Eligibility
Key inclusion criteria
1) age 18 years and over, 2) normal or overweight, 3) diagnosed with T2DM and managed via diet or diabetes medication (but not insulin), 4) no nut allergy, 5) non-regular-nut-consumers (intake <2 times/week)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients using insulin to control blood sugar levels, and 2) the presence of other illness that affects dietary intake and blood glucose levels, e.g. gastrointestinal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316518 0
University
Name [1] 316518 0
Deakin University
Country [1] 316518 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318696 0
None
Name [1] 318696 0
Address [1] 318696 0
Country [1] 318696 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315311 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 315311 0
Ethics committee country [1] 315311 0
Australia
Date submitted for ethics approval [1] 315311 0
17/04/2024
Approval date [1] 315311 0
Ethics approval number [1] 315311 0

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

Contacts
Principal investigator
Name 134298 0
Dr Sze-Yen Tan
Address 134298 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 134298 0
Australia
Phone 134298 0
+61 392468977
Fax 134298 0
Email 134298 0
[email protected]
Contact person for public queries
Name 134299 0
Sze-Yen Tan
Address 134299 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 134299 0
Australia
Phone 134299 0
+61 392468977
Fax 134299 0
Email 134299 0
[email protected]
Contact person for scientific queries
Name 134300 0
Sze-Yen Tan
Address 134300 0
Deakin University, 221 Burwood Highway, Burwood VIC 3125
Country 134300 0
Australia
Phone 134300 0
+61 392468977
Fax 134300 0
Email 134300 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
Data at a group level will be shared only


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.