Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000851268
Ethics application status
Approved
Date submitted
30/09/2009
Date registered
1/10/2009
Date last updated
10/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lipid emulsions and the control of body weight. Delivery Systems Study.
Scientific title
Bioactivity of dairy-derived lipids: Screening trials assessing postprandial satiety, energy intake and serum markers of appetite regulation in lean healthy males
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet & Nutrition 243822 0
Condition category
Condition code
Diet and Nutrition 239995 239995 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised, cross-over study in lean male participants (Body Mass Index (BMI) 18-25kg/m2). This study is the first of three parts and will investigate whether a commercially available lipid emulsion (OlibraTM) delivered as a single bolus “shot” or within different food components (a yoghurt or a muffin) has a differential effect on satiety, hunger and energy intake at the next meal (3.75 h later)

Subjects will be requested to fast for 12 hours prior to the test day.

Participants will be randomized to receive each of 6 treatments (200g) over the study period. A single treatment will be given on each study day. The treatments will be administered at the Human Nutrition Unit on the morning of the intervention at 09:00am. Specifically, the trial will measure the participants’ thoughts of hunger and fullness throughout a single day, and measure food intake at an ad libitum buffet style lunch meal given 225 minutes after the treatment. Study visits to be separated by a wash-out period of at least 1 day.

Treatments:

Shots:
A. 4.2g Control lipid + 10.8g water + 185g glass warm water
B. 15g OlibraTM + 185g glass of water.

Yoghurts:
C. 125g high fat yoghurt + 33.5g low fat yoghurt + 4g polycal (Nutricia) + 12.5g palm olein + 25g water.
D. 160g high fat yoghurt + 15g OlibraTM + 8g palm olein + 17g water.

Non-Dairy Foods:
E. Muffin + 4.2g palm olein + 81g water.
F. Muffin + 15g OlibraTM + 81g water.

Control lipid = palm olein; OlibraTM = commercially available ‘Slim Shot’; Polycal, Nutritia = a powdered, carbohydrate energy source, medical food containing maltodextrin.

Participants will be randomized to receive all 6 treatments detailed above over 6 study days. The 6 treatments are matched for total weight (200g). The 2 shot treatments (A and B) are matched for energy (155.4 kJ). The yoghurts and non-dairy foods are all matched for total energy (1165kJ), protein (6.8g), fat (15g) and carbohydrate (CHO) (28.8g). There must be at least 1 day between study visits. Participants are free to choose which days they come in to the unit so the study duration will be from 10 days to a couple of months if participants can only come in one day per week.
Intervention code [1] 241261 0
Treatment: Other
Comparator / control treatment
Control lipid = palm olein; a lipid with a fatty acid composition matched to OlibraTM emulsion. Control treatments = A, C and E.
Control group
Active

Outcomes
Primary outcome [1] 240898 0
Energy Intake at ad libitum lunch meal. Lunch items will be weighed by research staff pre- and post-meal, and energy, fat, CHO and protein intake calculated using the dietary program Foodworks.
Timepoint [1] 240898 0
Timepoint: 270 minutes post-treatment.
Secondary outcome [1] 257582 0
Secondary Outcome 1: Visual Analogue Scale (VAS) scores for hunger and fullness.
Timepoint [1] 257582 0
Time points: t= -10, 15, 30, 45, 60, 90, 120, 150, 180, 210, 270, 330 and 390 mins. These time points are set assuming t=0 is the time the treatment is administered. Therefore any negative time points refer to a VAS measurement taken that many minutes before the treatment. Positive time points are for VAS measurements at that number of minutes post-treatment.
Secondary outcome [2] 257583 0
Secondary Outcome 2: Visual Analogue Scale (VAS) scores for thoughts of food and satisfaction.
Timepoint [2] 257583 0
Time points: t= -10, 15, 30, 45, 60, 90, 120, 150, 180, 210, 270, 330 and 390 mins. These time points are set assuming t=0 is the time the treatment is administered. Therefore any negative time points refer to a VAS measurement taken that many minutes before the treatment. Positive time points are for VAS measurements at that number of minutes post-treatment.

Eligibility
Key inclusion criteria
Men, aged 18-65years.
Lean (BMI: Caucasian/Indian/Asian 17.5-25 kg/m2; Pacific Peoples 18.5-26 kg/m2).
No history of diabetes or heart disease.
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
Endocrine, cardiovascular, gastrointestinal (GI), metabolic disease or cancers, including history.
Weight change of +/-5 kg in the previous 6 months.
Medications that may affect weight/appetite.
Cigarette smoking within previous 6 months.
Unwilling unable to comply with protocol/participation in another clinical trial
Any current diagnosis or history of significant disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study is a randomised crossover study. Randomisation is carried out using a Latin square design, whereby next patient registered is allocated to the sequential randomisation code. The Latin square will be drawn prior to recruitment & as each participant is registered they will be assigned the next available registration number. The registration number is linked the Latin square & hence the order which each participant will receive the 6 treatments. Participants will be unaware of the order of which treatment they will be given at each visit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A Latin square will be used to randomise the subjects into the 6 treatments. As this is a cross-over trial, each participant will complete all 6 intervention arms.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2008
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] 2136 0
New Zealand
State/province [1] 2136 0
Auckland

Funding & Sponsors
Funding source category [1] 243723 0
Commercial sector/Industry
Name [1] 243723 0
Lactopharma
Country [1] 243723 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] 237087 0
University
Name [1] 237087 0
The University of Auckland
Address [1] 237087 0
Human Nutrition Unit, The University of Auckland, 18 Carrick Place, Mt Eden Auckland 1024
Country [1] 237087 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243852 0
Northern X Regional Ethics Committee
Ethics committee address [1] 243852 0
Ethics committee country [1] 243852 0
New Zealand
Date submitted for ethics approval [1] 243852 0
Approval date [1] 243852 0
30/06/2008
Ethics approval number [1] 243852 0
NTX 08/04/036

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

Contacts
Principal investigator
Name 30275 0
Address 30275 0
Country 30275 0
Phone 30275 0
Fax 30275 0
Email 30275 0
Contact person for public queries
Name 13522 0
Dr Kai Chan
Address 13522 0
Human Nutrition Unit
University of Auckland
18 Carrick Place, Mt Eden.
Auckland 1024.
Country 13522 0
New Zealand
Phone 13522 0
+64 9 630 3744
Fax 13522 0
+64 9 630 5764
Email 13522 0
[email protected]
Contact person for scientific queries
Name 4450 0
Dr Sally Poppitt
Address 4450 0
Human Nutrition Unit
University of Auckland
18 Carrick Place, Mt Eden.
Auckland 1024.
Country 4450 0
New Zealand
Phone 4450 0
+64 9 630 5160
Fax 4450 0
+64 9 630 5764
Email 4450 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
No additional documents have been identified.