Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000852257
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. Meal Termination Study.
Scientific title
Bioactivity of dairy-derived lipids:
Screening trials assessing postprandial satiety, energy intake and serum markers of appetite regulation in lean healthy male subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet & nutrition 243869 0
Condition category
Condition code
Diet and Nutrition 252042 252042 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 second of three parts and will investigate whether a commercially available lipid emulsion (OlibraTM) delivered as a single bolus “shot” or within a yoghurt has a differential effect on satiety, hunger and energy intake administered immediately prior to a meal.
Subjects will be requested to fast for 12 hours prior to the test day.

Participants will be randomized to receive each of 4 treatments 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 09:25am. Specifically, the trial will measure the participants’ thoughts of hunger and fullness throughout the morning of a single day, and measure food intake at an ad libitum buffet style breakfast meal given 5 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.

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 4 treatments detailed above over 4 study days. The treatments are matched for total weight (200g). The 2 shot treatments (A and B) are matched for energy (155.4 kJ). The yoghurts are 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 6 days to a couple of months if participants can only come in one day per week.
Intervention code [1] 241305 0
Treatment: Other
Comparator / control treatment
Control lipid = palm olein; a lipid with a fatty acid composition matched to OlibraTM emulsion. Control treatments = A and C.
Control group
Active

Outcomes
Primary outcome [1] 252944 0
Energy Intake at ad libitum breakfast meal. Breakfast 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] 252944 0
35 minutes post-test beverage
Secondary outcome [1] 257671 0
Secondary Outcome 1: Visual Analogue Scale (VAS) scores for hunger and fullness.
Timepoint [1] 257671 0
Time points: t= -5, 5, 35, 65, 95, 125 and 155 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] 257674 0
Secondary Outcome 2: Visual Analogue Scale (VAS) scores for thoughts of food and satisfaction.
Timepoint [2] 257674 0
Time points: t= -5, 5, 35, 65, 95, 125 and 155 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 18-65y
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, 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 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 4 treatments in this study. As this is a cross-over trial, each participant will complete all 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
30/03/2009
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] 2145 0
New Zealand
State/province [1] 2145 0
Auckland

Funding & Sponsors
Funding source category [1] 243759 0
Commercial sector/Industry
Name [1] 243759 0
Lactopharma
Country [1] 243759 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] 237115 0
University
Name [1] 237115 0
The University of Auckland
Address [1] 237115 0
Nutrition Unit, The University of Auckland, 18 Carrick Place, Mt Eden Auckland1024
Country [1] 237115 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243889 0
Northern X Regional Ethics Committee
Ethics committee address [1] 243889 0
Ethics committee country [1] 243889 0
New Zealand
Date submitted for ethics approval [1] 243889 0
Approval date [1] 243889 0
23/02/2009
Ethics approval number [1] 243889 0
NTX 08/04/036

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

Contacts
Principal investigator
Name 30303 0
Address 30303 0
Country 30303 0
Phone 30303 0
Fax 30303 0
Email 30303 0
Contact person for public queries
Name 13550 0
Dr Kai Chan
Address 13550 0
Human Nutrition Unit
University of Auckland
18 Carrick Place, Mt Eden
Auckland 1024
Country 13550 0
New Zealand
Phone 13550 0
+ 64 9 630 3744
Fax 13550 0
+ 64 9 630 5764
Email 13550 0
[email protected]
Contact person for scientific queries
Name 4478 0
Dr Sally Poppitt
Address 4478 0
Human Nutrition Unit
University of Auckland
18 Carrick Place, Mt Eden
Auckland 1024
Country 4478 0
New Zealand
Phone 4478 0
+64 9 630 5160
Fax 4478 0
+ 64 9 630 5764
Email 4478 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
EmbaseInvestigating acute satiation and meal termination effects of a commercial lipid emulsion: A breakfast meal study.2015https://dx.doi.org/10.1016/j.physbeh.2015.09.008
N.B. These documents automatically identified may not have been verified by the study sponsor.