Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001066875
Ethics application status
Approved
Date submitted
9/08/2012
Date registered
5/10/2012
Date last updated
8/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
SNAC Study- Satiety,
Nutrition and Appetite in Children
Scientific title
In obese children, will a blunted appetite profile and shortened period of satiety be exhibited compared to healthy Body Mass Index (BMI) controls after a macronutrient specific meal?
Secondary ID [1] 280895 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
SNAC (Satiety, Nutrition and Appetite in Children)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 286967 0
Condition category
Condition code
Diet and Nutrition 287309 287309 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Macronutrient specific meal- High carbohydrate or high protein in obese children.

The breakfast meals will be a milkshake. The energy content of the milkshake will be 25% of the participant's estimated energy requirements. The high carbohydrate will consist of 6%protein, 16% fat, 75% carbohydrate. The high protein will consist of 55% protein, 15% fat and 28% carbohydrate.

There will be two study mornings. On the first morning they will receive either one of two study breakfasts (high carbohydrate or high protein). They will then be asked to come back on a second morning after a minimum of 1 week washout to cross over and receive the alternate study meal.
Intervention code [1] 285326 0
Lifestyle
Comparator / control treatment
Macronutrient specific meal (High carbohydrate or high protein) in healthy weight children.

The breakfast meals will be a milkshake. The energy content of the milkshake will be 25% of the participant's estimated energy requirements. The high carbohydrate will consist of 6%protein, 16% fat, 75% carbohydrate. The high protein will consist of 55% protein, 15% fat and 28% carbohydrate.

There will be two study mornings. On the first morning they will receive either one of two study breakfasts (high carbohydrate or high protein). They will then be asked to come back on a second morning after a minimum of 1 week washout to cross over and receive the alternate study meal.
Control group
Active

Outcomes
Primary outcome [1] 287580 0
Postprandial changes in satiety and appetite gut hormones: ghrelin, PYY, GLP-1, CCK.
These will be measured using blood tests. We will collect blood samples, centrifuge the blood to obtain plasma and serum and analyse these using a Multiplex.
Timepoint [1] 287580 0
At baseline just prior to the test meal and during the postprandial period, i.e. up to 4 hours after the meal has been eaten.

So in summary, we will take blood before breakfast, and at 15mins, 30 mins, 60mins, 120 mins, 180 mins and 240 mins after breakfast is eaten.
Primary outcome [2] 287581 0
Energy intake (kj) at the subsequent meal and energy intake from everything consumed post lunch until lunch the next day.

We will assess the kj consumed at lunch by weighing out the amount of lunch supplied minus the amount that is left over.
We will assess the amount eaten post lunch until lunch the next day by asking participants to complete a food record. We will analyse the food record using a program called FoodWorks.
Timepoint [2] 287581 0
Four hours after the test meal (high carbohydrate or high protein breakfast), and up until lunch the next day.

We will assess this by measuring how much is eaten at lunch (as described above), and also by asking the participants to complete a food record of what they eat for the remainder of the day and up to before lunch on the next day. We will analyse the food record using a program called FoodWorks.
Primary outcome [3] 287585 0
VAS (Visual Analogue Scale) to measure hunger and fullness
Timepoint [3] 287585 0
At baseline just prior to the test meal and during the postprandial period, i.e. up to 4 hours after the meal has been eaten.

So in summary, the timepoints of the VAS scales will be before breakfast, and at 15mins, 30 mins, 60mins, 120 mins, 180 mins and 240 mins after breakfast is eaten.
Secondary outcome [1] 298457 0
Changes in energy expenditure after consuming the two different macronutrient meals in both obese and healthy weight children. Energy expenditure will be measured using indirect calorimetry.
Timepoint [1] 298457 0
Energy expenditure will be measured using indirect calorimetry at baseline and 30 minutes of every hour for four hours after the breakfast meal.

Eligibility
Key inclusion criteria
*Healthy weight - body mass index (BMI) within the 15th – 85th percentile for age and sex.
*Healthy obese - BMI > or = to 95th percentile for age and sex.
*Non smoking
*NOT taking medications or drugs known to alter body composition or metabolism, including insulin sensitisers, glucocorticoids, thyroxin
*NOT have obesity due to secondary causes relating to genetic disorders (e.g Prader-Willi syndrome, Down’s syndrome) or endocrinology-related disorders (e.g. hypothyroidism or growth hormone deficiency)
*NOT have lactose intolerance or follow any severely restricted diets or have complex food allergies
Minimum age
11 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Taking medications or drugs know to alter body composition or metabolism, including insulin sensitisers, glucocorticoids, thyroxin. Obesity due to secondary causes relating to genetic disorders (e.g Prader-Willi syndrome, Down’s syndrome) or endocrinology-related disorders (e.g. hypothyroidism or growth hormone deficiency) Those following severely restricted diets, such as those for complex allergies.

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)
Referral from paediatrician at Southern Health (paediatric endocrinology nutrition unit), for the obese group.

Healthy weight participants will be recruited from local advertisements displayed in Monash Medical Centre, Monash University, and the local community.

Randomisation will occur by using opaque, consecutively numbered, sealed envelopes with the group allocation
written on a piece of paper inside. The allocation sequence will be constructed using a computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur by using opaque, consecutively numbered, sealed envelopes with the group allocation
written on a piece of paper inside. The allocation sequence will be constructed using a computer program.
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
31/10/2012
Actual
19/06/2013
Date of last participant enrolment
Anticipated
Actual
11/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285685 0
University
Name [1] 285685 0
Monash University
Country [1] 285685 0
Australia
Primary sponsor type
Individual
Name
Dr Kate Huggins
Address
Monash University
Department of Nutrition and Dietetics
Faculty of Medicine, Nursing and Health Sciences

Level 1 264 Ferntree Gully Rd
Notting Hill VIC 3168, Australia
Country
Australia
Secondary sponsor category [1] 284513 0
Individual
Name [1] 284513 0
Maxine Bonham
Address [1] 284513 0
Monash University
Department of Nutrition and Dietetics
Faculty of Medicine, Nursing and Health Sciences

Level 1 264 Ferntree Gully Rd
Notting Hill VIC 3168, Australia
Country [1] 284513 0
Australia
Secondary sponsor category [2] 284514 0
Individual
Name [2] 284514 0
Professor Helen Truby
Address [2] 284514 0
Monash University
Department of Nutrition and Dietetics
Faculty of Medicine, Nursing and Health Sciences

Level 1 264 Ferntree Gully Rd
Notting Hill VIC 3168, Australia
Country [2] 284514 0
Australia
Other collaborator category [1] 276965 0
Individual
Name [1] 276965 0
Kay Nguo
Address [1] 276965 0
Monash University
Department of Nutrition and Dietetics
Faculty of Medicine, Nursing and Health Sciences

Level 1 264 Ferntree Gully Rd
Notting Hill VIC 3168, Australia
Country [1] 276965 0
Australia
Other collaborator category [2] 276966 0
Individual
Name [2] 276966 0
Dr Elizabeth Manickham
Address [2] 276966 0
Monash University
Department of Nutrition and Dietetics
Faculty of Medicine, Nursing and Health Sciences

Level 1 264 Ferntree Gully Rd
Notting Hill VIC 3168, Australia
Country [2] 276966 0
Australia
Other collaborator category [3] 276967 0
Individual
Name [3] 276967 0
A/Prof Terry Haines
Address [3] 276967 0
Monash University
Clayton campus
Wellington Road
Clayton
Victoria 3800
Australia
Department of Physiotherapy, Faculty of Medicine, Nursing and Health Sciences
Country [3] 276967 0
Australia
Other collaborator category [4] 276968 0
Individual
Name [4] 276968 0
Dr Justin Brown
Address [4] 276968 0
Monash University
Clayton campus
Wellington Road
Clayton
Victoria 3800
Australia
Department of Paediatrics, Faculty of Medicine, Nursing and Health Sciences


Southern Health- Monash Medical Centre
Monash Children's Paediatric Endocrinology Unit
246 Clayton Road
Clayton VIC 3168
Country [4] 276968 0
Australia
Other collaborator category [5] 276969 0
Individual
Name [5] 276969 0
Dr Jeff Kung-Ting Kao
Address [5] 276969 0
Southern Health- Monash Medical Centre
Monash Children's Paediatric Endocrinology Unit
246 Clayton Road
Clayton VIC 3168
Country [5] 276969 0
Australia
Other collaborator category [6] 276970 0
Individual
Name [6] 276970 0
Dr Zane Andrews
Address [6] 276970 0
Monash University
Clayton campus
Wellington Road
Clayton
Victoria 3800
Australia
Department of Physiology, Faculty of Medicine, Nursing and Health Sciences
Country [6] 276970 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287671 0
Southern Health HREC B
Ethics committee address [1] 287671 0
Ethics committee country [1] 287671 0
Australia
Date submitted for ethics approval [1] 287671 0
Approval date [1] 287671 0
29/06/2012
Ethics approval number [1] 287671 0
12104B
Ethics committee name [2] 287793 0
Monash University Human Research Ethics Commitee (MUHREC)
Ethics committee address [2] 287793 0
Ethics committee country [2] 287793 0
Australia
Date submitted for ethics approval [2] 287793 0
Approval date [2] 287793 0
12/07/2012
Ethics approval number [2] 287793 0
CF12/1987-2012001086

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

Contacts
Principal investigator
Name 34473 0
Dr Kate Huggins
Address 34473 0
Department of Nutrition and Dietetics,
Monash University, Faculty of Medicine, Nursing and Health Sciences
Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168, Australia
Country 34473 0
Australia
Phone 34473 0
+61 3 9902 4269
Fax 34473 0
Email 34473 0
[email protected]
Contact person for public queries
Name 17720 0
Kay Nguo
Address 17720 0
Department of Nutrition and Dietetics
Monash University, Faculty of Medicine, Nursing and Health Sciences
264 Ferntree Gully Roa, Notting Hill
VIC 3168, Australia
Country 17720 0
Australia
Phone 17720 0
+61 3 9902 4199
Fax 17720 0
Email 17720 0
[email protected]
Contact person for scientific queries
Name 8648 0
Dr Catherine Huggins
Address 8648 0
Department of Nutrition and Dietetics
Monash University, Faculty of Medicine, Nursing and Health Sciences
264 Ferntree Gully Road, Notting Hill
VIC 3168, Australia
Country 8648 0
Australia
Phone 8648 0
+61 3 9902 4269
Fax 8648 0
Email 8648 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 macronutrient composition on meal-induced thermogenesis in adolescents with obesity.2019https://dx.doi.org/10.1007/s00394-018-1783-1
N.B. These documents automatically identified may not have been verified by the study sponsor.