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Trial registered on ANZCTR


Registration number
ACTRN12617000294358
Ethics application status
Approved
Date submitted
21/02/2017
Date registered
24/02/2017
Date last updated
12/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a high protein low carbohydrate meal compared with a control meal on morning and evening glucose responses in healthy adults.
Scientific title
The effect of a high protein low carbohydrate meal compared with a control meal on morning and evening glucose responses in healthy adults: a cross-over study
Secondary ID [1] 290944 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial glucose 301675 0
Type 2 Diabetes 301676 0
Shift work 302029 0
Condition category
Condition code
Diet and Nutrition 301383 301383 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 301805 301805 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME
High protein low carbohydrate (HP/LC) test meal.
WHY
Postprandial glucose responses are elevated in the evening compared with the morning. This may be a risk factor for Type 2 diabetes for those who frequently eat at night, e.g shift workers. The purpose of this study is to determine if a high protein low carbohydrate meal is an effective strategy for lowering evening glucose responses compared with a control meal.
WHAT
Materials:
All participants will be provided with a standardised test meal to consume (vegetarian pasta with sauce and a milkshake) at the study session, which is pre-prepared by the researchers. The total energy content for the HP/LC test meal per serve is 3.26MJ, with 41% of energy from protein, 28% from fat, and 29% from carbohydrates. During the intervention a paper based 100mm Visual Analogue Scale will also be administered to participants asking them to rate their hunger and fullness.
All participants are provided with a standardised pre-study session meal which is to be consumed at least 10 hours prior to attendance at the research facility, i.e. last meal before commencing 10 hour fast. This pre-study session meal consists of the following store bought items; vegetarian frozen meal, low fat yoghurt, and packet of nuts.
Materials used to collect anthropometric measurements include; scales, stadiometer, Medical Body Composition analyser SECA, and automated blood pressure monitor.
The researchers will use an automated clinical chemical analyser to measure the plasma glucose concentrations of blood samples. The plasma insulin concentrations will be analysed using a human insulin ELISA kit and measured on a microplate reader.
Procedures:
Upon arriving at the research facility, after a 10 hour fast, participants will have their anthropometric measurements taken including weight, height, body composition and blood pressure. A trained phlebotomist will fit an intravenous cannula in the arm and one baseline blood sample will be taken at time 0 minutes. Participants will then be given the test meal (either the HP/LC or an isocaloric control) to consume within 15 minutes at either 8:00am in the morning session or 8:00pm in the evening session. Blood samples will be collected at subsequent time points: 15, 30, 45, 60, 90, 120 and 180 mins after participants commenced eating the meal. At each time point participants will also be asked to mark a 100mm Visual Analogue Scale rating their hunger and fullness.
WHO PROVIDED
The cannulation of participants and blood collection will be carried out by a trained phlebotomist or nurse who has experience with cannulation.
HOW
The study sessions will be carried out face to face, in groups of no more than 3 participants.
WHERE
The study sessions will be carried out in the Be Active Sleep and Eat (BASE) Facility laboratory located in Notting Hill, Victoria.
WHEN and HOW MUCH
Each participant will attend 4 study sessions in total (2 testing the HP/LC meal and 2 testing a control meal), each session will run for approximately 3.5 hours. Study sessions are scheduled based on convenience and there will be a minimum wash out period of at least 7 days between sessions. The ordering of sessions will be determined based on the availablility of the phlebotomist and the participants’ schedule.
Intervention code [1] 296890 0
Lifestyle
Comparator / control treatment
Each participant will complete two study sessions (one in the morning at 8am and one in the evening at 8pm) where they will consume a control meal which is isocaloric to the HP/LC test meal. The control meal consists of a vegetarian pasta dish and milkshake containing 3.26MJ of energy, of which 15% is from protein, 34% from fat and 46% from carbohydrate. Apart from the different meal, all other procedures are as described for the intervention condition.
Control group
Active

Outcomes
Primary outcome [1] 300781 0
Postprandial plasma glucose iAUC, measured with an automated clinical chemical analyser (Indiko).
Timepoint [1] 300781 0
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 beginning consumption of the test meal.
Secondary outcome [1] 330840 0
Postprandial total area under the curve of self-rated hunger and fullness scores, measured on a 100mm visual analogue scale.
Timepoint [1] 330840 0
Three hour self-rated hunger and fullness AUC will be calculated from 100mm visual analogue scales administered at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.
Secondary outcome [2] 331698 0
Postprandial plasma insulin iAUC, analysed with a human insulin ELISA kit and measured on a microplate reader.
Timepoint [2] 331698 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 beginning consumption of the test meal.

Eligibility
Key inclusion criteria
Healthy adult male and females that do not work shift work, have regular sleeping patterns and have a BMI between 18.5 kg/m2 and 30 kg/m2.
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: <18.5kg/m2 and > 30kg/m2
Diagnosed with type 2 diabetes or taking anti-diabetic medication (oral hypoglycaemic agents)
Impaired fasting glucose (>6mmol/L)
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
All participants complete a total of 4 study sessions, consuming each test meal (either the high protein / low carbohydrate or control meal) on two separate occasions (in the morning at 8:00am or in the evening at 8:00pm). The order of scheduling of the sessions will not be randomised.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined from referencing a similar postprandial meal challenge that had previously been conducted at the BASE Facility. A power calculation indicated that the sample size would allow for detection of a difference in postprandial glucose iAUC with 90% power and an alpha of 0.05, and also allow for attrition. Wilcoxon signed rank test between matching pairs will be used to assess if there is a difference in glucose response between the HP/LC test meal and control meal within subjects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/07/2016
Date of last participant enrolment
Anticipated
17/03/2017
Actual
10/05/2017
Date of last data collection
Anticipated
14/04/2017
Actual
15/06/2017
Sample size
Target
30
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295369 0
University
Name [1] 295369 0
Monash University
Country [1] 295369 0
Australia
Primary sponsor type
Individual
Name
Dr Catherine Huggins
Address
Department of Nutrition and Dietetics,
Monash University
Level 1
264 Ferntree Gully Road
Notting Hill
VIC
3168
Country
Australia
Secondary sponsor category [1] 294192 0
None
Name [1] 294192 0
None
Address [1] 294192 0
None
Country [1] 294192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296703 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 296703 0
Ethics committee country [1] 296703 0
Australia
Date submitted for ethics approval [1] 296703 0
24/04/2015
Approval date [1] 296703 0
29/04/2015
Ethics approval number [1] 296703 0
CF15/1301 – 2015000620

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

Contacts
Principal investigator
Name 71802 0
Dr Catherine Huggins
Address 71802 0
Monash University
Department of Nutrition and Dietetics
Level 1
264 Ferntree Gully Road
Notting Hill
Victoria
3168
Country 71802 0
Australia
Phone 71802 0
+61 (3) 9902 4277
Fax 71802 0
Email 71802 0
kate.huggins@monash.edu
Contact person for public queries
Name 71803 0
Catherine Huggins
Address 71803 0
Monash University
Department of Nutrition and Dietetics
Level 1
264 Ferntree Gully Road
Notting Hill
Victoria
3168
Country 71803 0
Australia
Phone 71803 0
+61 (3) 9902 4277
Fax 71803 0
Email 71803 0
kate.huggins@monash.edu
Contact person for scientific queries
Name 71804 0
Catherine Huggins
Address 71804 0
Monash University
Department of Nutrition and Dietetics
Level 1
264 Ferntree Gully Road
Notting Hill
Victoria
3168
Country 71804 0
Australia
Phone 71804 0
+61 (3) 9902 4277
Fax 71804 0
Email 71804 0
kate.huggins@monash.edu

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
EmbaseGlycaemic response at night is improved after eating a high protein meal compared with a standard meal: A cross-over study.2020https://dx.doi.org/10.1016/j.clnu.2019.06.014
EmbaseDiurnal variation in gene expression of human peripheral blood mononuclear cells after eating a standard meal compared with a high protein meal: A cross-over study.2021https://dx.doi.org/10.1016/j.clnu.2021.01.011
N.B. These documents automatically identified may not have been verified by the study sponsor.