Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000164493
Ethics application status
Approved
Date submitted
11/01/2016
Date registered
10/02/2016
Date last updated
10/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of meal timing on postprandial glucose in healthy volunteers
Scientific title
The effect of meal timing on postprandial glucose in healthy volunteers
Secondary ID [1] 288278 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postprandial glucose 297235 0
Type 2 Diabetes 297236 0
Condition category
Condition code
Diet and Nutrition 297441 297441 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part one – OGTT
After a ten hour fast participants will report to the BASE facility at either 0730h (morning) or 1930h (evening). Anthropometric measures (height, weight, blood pressure, waist circumference and blood pressure) will be obtained by a researcher and two blood samples for fasting glucose (finger prick) will be taken at time -15 mins and time 0 mins. A glucose solution made from pure glucose powder (75g in 400 ml water) will be provided at 0800h or 2000 hrs and participants asked to consume this within five minutes. Blood sampling (finger prick) for glucose assessment will be collected at the following time points over a two hour period (15, 30, 45, 60, 90, 120 mins). Washout between study days is a minimum of three days.

Part two – Low GI meal
Part two replicates part one except an Intravenous cannula will be inserted by an experienced nurse or phlebotomist thirty minutes before the start of the trial. One baseline blood sample will be taken at time 0 mins followed by a low GI meal at 0800h or 2000h which participants will be asked to consume within 15 minutes. Blood sampling will be collected at 15, 30, 45, 60, 9, 120 and 180 mins for glucose and insulin. Participants are able to opt in to a third time point where they will consume the same GI meal at midnight. The washout period between each of the meal occasions is a minimum of three days.
The low glycaemic index meal is a vegetarian pasta dish which consists of of 3.28MJ, with 47% Energy (E) from carbohydrate, 40%E from fat and 11%E from protein.
Intervention code [1] 293572 0
Lifestyle
Comparator / control treatment
Comparator is the OGTT/meal in the evening compared to the morning
Control group
Active

Outcomes
Primary outcome [1] 296997 0
Glucose (incremental area under the curve) is assessed from blood samples (finger prick in part one and venous blood in study two)
Timepoint [1] 296997 0
Two hour glucose iAUC will be calculated from finger prick blood samples at seven time points (-10, 0, 15, 30, 45, 60, 90 and 120 mins) after the OGTT (part one). Please note the -10 sample and 0 min sample will be averaged.
Three hour glucose iAUC will be calculated from venous blood samples at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after the low GI meal (part two)
Secondary outcome [1] 319820 0

Insulin (incremental area under the curve) is assessed from blood samples (finger prick in part one and venous blood in study two)
Timepoint [1] 319820 0
Three hour insulin iAUC will be calculated from venous blood samples at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after the low GI meal (part two)

Samples were not collected for insulin in part one (OGTT)

Eligibility
Key inclusion criteria
Healthy adults (18-50 years) who do not currently engage in shift work and have regular sleeping patterns
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently shift workers or night workers
Age: > 50 years
Body mass index: <18.5 and > 30
Diagnosed with type 2 diabetes or taking anti-diabetic medication (oral hypoglycaemic agents)
Impaired fasting glucose
Taking lipid-lowering medication

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
Crossover
Other design features
The study is divided into two parts both of which involve undergoing an OGTT (part one) or consuming a low GI meal (part two) at two time points (8am and 8pm).
Part one is completed before part two
After completing part two (low GI meal), participants are given the opportunity to complete an additional time point at midnight. If this option is taken up it would mean that there are three timepoints in the low GI meal part (8am, 8pm and 1200 midnight)

Part two has an opt in to undertaking a third postprandial meal challenge at midnight
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Incremental area under the curve for glucose response will be the primary outcome measure for both parts of the study but data will not be compared between parts one and two as the starting carbohydrate load is not equivalent. Glucose response over the postprandial period will be estimated using incremental area under the response curve (iAUC). The iAUC will be calculated by the trapezoid rule, which ignores the area beneath the fasting level.. Insulin response (secondary outcome) will be assessed as iAUC as per glucose but only in part two if the study (not collected in part one).
Due to the small sample size required for this study, all data will be reported as median (interquartile range), except for the postprandial glucose and insulin time course graphs which will be presented as mean +/- SEM. Wilcoxon signed-rank test will be used used to determine the difference in 1) iAUC, 2) concentration at the end of postprandial period occasion and 3) fasting level, between morning and night occasions. Statistical significance was considered at p<0.05. Statistical analyses were conducted using Statistical Package for Social Sciences (SPSS) (version 21.0, IBM Corp., New York).

Nine participants were required, to provide 80% power and detect a mean difference of 15% in glucose concentration (total area under response curve) at an alpha value of 0.05. Sample size calculations were based on data from a study (Al-Naimi et al, 2004) that administered meals at 1300h (day time point) and at 0100h (night time point).
Al-Naimi S, Hampton SM, Richard P, Tzung C, Morgan LM. Postprandial metabolic profiles following meals and snacks eaten during simulated night and day shift work. Chronobiol. Int. 2004;21:937-947
To allow for drop outs, we plan to recruit 12 participants

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/07/2015
Date of last participant enrolment
Anticipated
29/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292657 0
University
Name [1] 292657 0
Monash University
Country [1] 292657 0
Australia
Primary sponsor type
Individual
Name
Dr Maxine Bonham
Address
Department of Nutrition and Dietetics,
Monash University
Level 1
264 Ferntree Gully Road
Notting Hill
VIC
3168
Country
Australia
Secondary sponsor category [1] 291375 0
None
Name [1] 291375 0
none
Address [1] 291375 0
none
Country [1] 291375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294130 0
Monash University HREC
Ethics committee address [1] 294130 0
Ethics committee country [1] 294130 0
Australia
Date submitted for ethics approval [1] 294130 0
24/04/2015
Approval date [1] 294130 0
29/04/2015
Ethics approval number [1] 294130 0
CF15/1301 - 2015000620

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

Contacts
Principal investigator
Name 62610 0
A/Prof Maxine Bonham
Address 62610 0
Monash University
Department of Nutrition and Dietetics
Level 1
264 Ferntree Gully Road
Notting Hill
Victoria
3168
Country 62610 0
Australia
Phone 62610 0
+61 3 99024272
Fax 62610 0
Email 62610 0
[email protected]
Contact person for public queries
Name 62611 0
Maxine Bonham
Address 62611 0
Monash University
Department of Nutrition and Dietetics
Level 1
264 Ferntree Gully Road
Notting Hill
Victoria
3168
Country 62611 0
Australia
Phone 62611 0
+61 3 99024272
Fax 62611 0
Email 62611 0
[email protected]
Contact person for scientific queries
Name 62612 0
Maxine Bonham
Address 62612 0
Monash University
Department of Nutrition and Dietetics
Level 1
264 Ferntree Gully Road
Notting Hill
Victoria
3168
Country 62612 0
Australia
Phone 62612 0
+61 3 99024272
Fax 62612 0
Email 62612 0
[email protected]

No information has been provided regarding IPD availability


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 meal timing on postprandial glucose responses to a low glycemic index meal: A crossover trial in healthy volunteers.2019https://dx.doi.org/10.1016/j.clnu.2017.11.010
N.B. These documents automatically identified may not have been verified by the study sponsor.