Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000193077
Ethics application status
Approved
Date submitted
16/02/2010
Date registered
4/03/2010
Date last updated
10/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Differential effects of saturated & unsaturated fats on satiety and energy intake
Scientific title
Effect of fatty acid saturation on satiety & energy intake in healthy male adults
Secondary ID [1] 1440 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 256669 0
Condition category
Condition code
Diet and Nutrition 256826 256826 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised, 3 treatment cross-over trial designed to measure the differential effects of saturated & unsaturated fats on satiety & energy intake when delivered as part of a high fat breakfast test meal. The high-fat test breakfasts (2.0 MJ) containing 26g lipid are given to 18 healthy, lean Body Mass Index (BMI) 18-25 kg/m2) men, each treatment separated by a washout period of at least 3 days. The washout period was not to be greater than 28 days. Participants scheduled their visits as per their availability taking into account the washout period. The breakfasts are high in saturated (SFA, 65% of total fat), polyunsaturated (PUFA, 76%) or monounsaturated (MUFA, 76%) fatty acids, and comprise 2 savoury muffins. Participants rate appetite sensations using visual analogue scales (VAS) to assess palatability immediately following the meals, and hunger and fullness throughout the day.
A venous cannula is inserted for sequential collection of blood samples throughout the morning to measure a number of factors thought to be associated with weight control. The test breakfast is served at 0830h and participants are asked to consume the test-meal in full but at their own pace within a 15 minute period. No further foods are allowed throughout the morning until an ad lib lunch meal is served 215 minutes later, at 1205h, to assess energy and macronutrient intake.

High-fat test breakfasts:
The 3 breakfast treatments are High Fat (HF) (50 en% fat) and isoenergetic (2.0 MJ), comprising 2 savoury muffins (ingredients: flour, skimmed milk powder, eggs, tomato, ham, test lipid). The lipids are included as an integral part of the recipe and baked into the muffins. The test breakfast is served at 0830h, co-presented with 300ml water. The treatments differ in fatty acid composition and are (i) high-SFA (from butter fat), (ii) high-PUFA (from safflower oil) or (iii) high-MUFA (from olive oil).
Intervention code [1] 255973 0
Treatment: Other
Intervention code [2] 256080 0
Prevention
Comparator / control treatment
Not applicable
Control group
Active

Outcomes
Primary outcome [1] 257787 0
Energy Intake at ad libitum lunch meal. Lunch items are weighed pre- and post-meal, and energy, fat, carbohydrate (CHO) and protein intake calculated using the dietary program Foodworks.
Timepoint [1] 257787 0
t=215mins
Secondary outcome [1] 263188 0
Visual Analogue Scale (VAS) scores for hunger and fullness.
Timepoint [1] 263188 0
Time points: t= -15, 15, 30, 45, 60, 90,120, 150, 180, 210, 270, 330, 390 mins
Secondary outcome [2] 263190 0
Blood analyses:
Response of circulating hormones and other factors associated with appetite regulation.
Timepoint [2] 263190 0
Time points: t= -15, 15, 30, 45, 60, 90,120, 150, 180, 210, 270, 330, 390 mins

Eligibility
Key inclusion criteria
- men, aged 18-65y
- lean (BMI<25kg/m2)
- healthy, as ascertained by self-report
- desire to participate in clinical trial
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- type I or II diabetes mellitus
- other endocrine, cardiovascular or metabolic disease
- smoking
- overweight/obesity

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)
This is a randomised, cross-over trial. Randomisation is carried out using a Latin square design, whereby the next patient registered is allocated to the sequential randomisation code. The Latin square that determines the order of treatments is made prior to any participant being enrolled into the study. The order by which participants are enrolled into the study determines the order by which they will complete the arms of the study. Allocation is not concealed to research staff
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A Latin square will be used to randomise the subjects to each of the 3 intervention arms. Each participant is randomized to complete all 3 intervention arms. The order by which treatments are recieved is determined by the order in which participants are enrolled into the study. The first person enrolled will complete the treatments in the order of the first line of the Latin square, the second subject enrolled will complete the treatments as per the order on the second line etc
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 2436 0
New Zealand
State/province [1] 2436 0
Auckland

Funding & Sponsors
Funding source category [1] 256473 0
Commercial sector/Industry
Name [1] 256473 0
Lactopharma
Country [1] 256473 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Lactopharma
Address
Fonterra Centre, 9 Princes Street, Private Bag 92032, Auckland
Country
New Zealand
Secondary sponsor category [1] 255781 0
None
Name [1] 255781 0
Address [1] 255781 0
Country [1] 255781 0
Other collaborator category [1] 1112 0
University
Name [1] 1112 0
University of Auckland
Address [1] 1112 0
Human Nutrition Unit, The University of Auckland, 18 Carrick Place, Mt Eden 1024
Country [1] 1112 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258524 0
Northern X Regional Ethics Committee
Ethics committee address [1] 258524 0
Ethics committee country [1] 258524 0
New Zealand
Date submitted for ethics approval [1] 258524 0
20/06/2005
Approval date [1] 258524 0
09/09/2005
Ethics approval number [1] 258524 0
NTX/05/07/090

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

Contacts
Principal investigator
Name 30763 0
Address 30763 0
Country 30763 0
Phone 30763 0
Fax 30763 0
Email 30763 0
Contact person for public queries
Name 14010 0
Dr Sally Poppitt
Address 14010 0
Human Nutrition Unit, the University of Auckland, 18 Carrick Place, Mt Eden 1024
New Zealand
Country 14010 0
New Zealand
Phone 14010 0
+64 9 630 5160
Fax 14010 0
+64 9 630 5764
Email 14010 0
[email protected]
Contact person for scientific queries
Name 4938 0
Dr Sally Poppitt
Address 4938 0
Human Nutrition Unit, the University of Auckland, 18 Carrick Place, Mt Eden 1024
New Zealand
Country 4938 0
New Zealand
Phone 4938 0
+64 9 630 5160
Fax 4938 0
+64 9 630 5764
Email 4938 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
Dimensions AINo evidence of differential effects of SFA, MUFA or PUFA on post-ingestive satiety and energy intake: a randomised trial of fatty acid saturation2010https://doi.org/10.1186/1475-2891-9-24
N.B. These documents automatically identified may not have been verified by the study sponsor.