Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000466640
Ethics application status
Approved
Date submitted
28/04/2014
Date registered
5/05/2014
Date last updated
29/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of dietary fats on appetite and metabolism
Scientific title
The effect of dietary fats on the postprandial appetite and metabolism response in overweight healthy men aged 18-40 years old.
Secondary ID [1] 284475 0
Nil Known
Universal Trial Number (UTN)
U1111-1155-9783
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 291715 0
Obesity 291716 0
Condition category
Condition code
Diet and Nutrition 292093 292093 0 0
Obesity
Diet and Nutrition 292108 292108 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be two high saturated fat muffins (40% total fat of which 50% is saturated fat) differing in saturated fatty acid chain lengths.

One muffin will be higher in long chain saturated fatty acids (99% long chain and 1% short chain) and one will be lower in long chain saturated fatty acids (70% long chain and 30% short chain). The total grams of fat will be approximately 46grams.



Intervention code [1] 289238 0
Lifestyle
Comparator / control treatment
The control/comparator muffin will be a high fat monounsaturated fat muffin (40% total fat of which 70% is monounsaturated). The total grams of fat will be approximately 46 grams.

All of the three test muffins will be isocaloric (~3500kj) and have similar macronutrient content (40% fat, 15% protein and 45% CHO). The total grams of fat will be approximately 46 grams in each muffin serve.

There will be three study mornings. On the first two mornings the participants will randomly receive one of the two saturated fat muffins They will then be asked to come back on a third morning to receive the monounsaturated fat muffin. There will be a minimum of a 1 week washout period between each visit.
Control group
Active

Outcomes
Primary outcome [1] 291983 0
Energy expenditure as assessed by indirect calorimetry
Timepoint [1] 291983 0
Baseline and at 1,2,3,4,5 and 6 hours after the muffin breakfast
Primary outcome [2] 291984 0
Hunger and Fullness as assessed by visual analogue scale (VAS)
Timepoint [2] 291984 0
Baseline and at 1,2,3,4,5 and 6 hours after the muffin breakfast
Primary outcome [3] 291985 0
Blood lipid response including triglyceride and cholesterol, as well as insulin and glucose as assessed by blood sampling
Timepoint [3] 291985 0
Baseline and at 1,2,3,4,5 and 6 hours after the muffin breakfast
Secondary outcome [1] 307960 0
Appetite hormones including ghrelin, PYY, GLP-1, CCK as assessed by blood sampling
Timepoint [1] 307960 0
Baseline and at 1,2,3,4,5 and 6 hours after the muffin breakfast

Eligibility
Key inclusion criteria
Male aged 18-40 years old
BMI 27kg/m2 - 35kg/m2 if you are Caucasian; or BMI 25kg/m2 to 30kg/m2 if you are Asian/Indian
Waist Circumference more than 102 cm if you are Caucasian, or more than 92 cm if you are Asian/Indian
Weight stable (within +/-2kg in the last 6 months)
Non-smoker

Fasting blood glucose levels less than 6.0mmol/L
Fasting triglyceride levels less than 3.0 mmol/L
Fasting cholesterol less than 6.0mmol/L
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Taking any medications known to alter body composition or metabolism e.g. thyroxin, glucocorticoids
Obesity due to secondary causes relating to genetic or endocrinology related disorders
Lactose intolerant or vegetarian
Diagnosed with, and or on drug therapy for diabetes, high blood pressure, high cholesterol or cardiovascular disease

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)
Participants will be recruited through voluntary response from advertisements placed in the community, social media or by personal approach.
1. Volunteers will express their interest to participate by sending an email or making a telephone call to the researcher listed on the advertisement. The interested volunteer will then be sent an explanatory statement and consent form
2. Initial screening will be conducted by telephone call or email and will involve answering questions relating to the inclusion criteria
3. If volunteers meet all the inclusion criteria, they will be asked to make an appointment to have a site visit to complete the screening and consent process.
4. The volunteer will have the opportunity to ask any further questions before agreeing to complete the screening procedures and participate in the study by signing the consent form. This screening visit will take approximately 30 minutes. The participants will be required to fast for at least 10 hours the night before to facilitate the fasting blood glucose and lipid screening tests. At this visit the volunteer will have their waist, height and weight measured and fasting finger prick blood samples collected to confirm all eligibility criteria have been met. Given these measurements meet all inclusion criteria; this will complete the screening process and the participant will be invited to enrol into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence was generated using a computerised random number generator to allocate the meal sequence for the first and second day of the study. This sequence was concealed in a password protected folder until interventions were assigned.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
The design of this study was a 'parallel randomised single blinded three-way cross over study'.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Thirteen healthy male overweight and obese volunteers aged 18-40 years old will be required to complete the study. This number is based on energy expenditure levels reported in the literature, to detect a 25% difference in energy expenditure after an isocaloric SFA and MUFA breakfast meal at a power of 80%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/05/2014
Actual
14/05/2014
Date of last participant enrolment
Anticipated
Actual
3/12/2014
Date of last data collection
Anticipated
Actual
28/02/2015
Sample size
Target
13
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289134 0
University
Name [1] 289134 0
Monash University
Country [1] 289134 0
Australia
Primary sponsor type
Individual
Name
Dr Maxine Bonham
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
Country
Australia
Secondary sponsor category [1] 287798 0
Individual
Name [1] 287798 0
Dr Kate Huggins
Address [1] 287798 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
Country [1] 287798 0
Australia
Secondary sponsor category [2] 287799 0
Individual
Name [2] 287799 0
Kay Nguo
Address [2] 287799 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
Country [2] 287799 0
Australia
Secondary sponsor category [3] 287800 0
Individual
Name [3] 287800 0
Professor Helen Truby
Address [3] 287800 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
Country [3] 287800 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290912 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 290912 0
Ethics committee country [1] 290912 0
Australia
Date submitted for ethics approval [1] 290912 0
09/12/2013
Approval date [1] 290912 0
19/12/2013
Ethics approval number [1] 290912 0
CF13/3165 - 2013001679

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

Contacts
Principal investigator
Name 47902 0
Dr Maxine Bonham
Address 47902 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
Country 47902 0
Australia
Phone 47902 0
+61 3 9902 4272
Fax 47902 0
Email 47902 0
[email protected]
Contact person for public queries
Name 47903 0
Kay Nguo
Address 47903 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
Country 47903 0
Australia
Phone 47903 0
+61 3 9902 4199
Fax 47903 0
Email 47903 0
[email protected]
Contact person for scientific queries
Name 47904 0
Maxine Bonham
Address 47904 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
Country 47904 0
Australia
Phone 47904 0
+61 3 9902 4272
Fax 47904 0
Email 47904 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
EmbaseNo effect of saturated fatty acid chain length on meal-induced thermogenesis in overweight men.2018https://dx.doi.org/10.1016/j.nutres.2018.01.003
N.B. These documents automatically identified may not have been verified by the study sponsor.