Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000853246
Ethics application status
Approved
Date submitted
30/09/2009
Date registered
1/10/2009
Date last updated
21/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Lipid emulsions and the control of body weight. Main 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
Secondary ID [1] 287508 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet and Nutrition 243871 0
Condition category
Condition code
Diet and Nutrition 252044 252044 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 third of three parts and will investigate the potential bioactive properties of orally administered dairy lipids on satiety, hunger, energy intake and circulating hormones and other factors associated with appetite regulation, as compared with the commercially available lipid emulsion.
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 yoghurt) 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 08:30am. This study is assessing the response of circulating hormones and other factors associated with appetite regulation including glucose, insulin, lipids including cholesterol, triacylglycerol & free fatty acids (FFA), Cholecystokinin (CCK), leptin, ghrelin, adiponectin, Glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). A cannula will be inserted in the participants arm upon arrival to the Human Nutrition Unit on the morning of the intervention (~08:00am). 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 as well as the levels of circulating hormones and other factors associated with appetite regulation. Study visits to be separated by a wash-out period of at least 7 days.

Treatments:
The treatments described below are for delivery of a single bolus lipid emulsion ‘shot’ (10g) incorporated into a dairy-yoghurt (190g).
The composition of the 6 shots are:
A. Control lipid + phospholipid emulsion with fatty acid composition matched to Olibra

B. Dairy lipid + phospholipid emulsion with fatty acid composition not matched to Olibra

C. Non-emulsified control lipid + phospholipid with fatty acid composition matched to Olibra

D. Non-emulsified dairy lipid + phospholipid with fatty acid composition not matched to Olibra

E. Dairy lipid + soy lecithin emulsion with fatty acid composition not matched to Olibra

F. OlibraTM emulsion

The composition of the 760 kJ fixed load yoghurt that the shots will be mixed into:
5.7g fat, 28 en% fat
6.5g protein, 14 en% protein
27.4g Carbohydrate (CHO), 58 en% CHO


Participants will be randomized to receive all 6 beverages detailed above over 6 study days. The treatments are matched for weight (200g) and macronutrient composition. Treatments A, C and F will have similar fatty acid composition (matched to that of Olibra – the commercially available lipid emulsion). Treatments B, D and E containing the dairy lipid will have a different fatty acid composition to treatments A, C and F. There must be at least 7 days between study visits in this study. Participants are free to choose which days they come in to the unit so the study duration will be from 6 weeks to a few months.
Intervention code [1] 241307 0
Treatment: Other
Comparator / control treatment
Comparator lipid = OlibraTM emulsion. Comparator treatment = F; Control lipid = palm olein. Control treatments = A and C.
Control group
Active

Outcomes
Primary outcome [1] 252946 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] 252946 0
Timepoint: 270 minutes post-treatment.
Secondary outcome [1] 257675 0
Secondary Outcome 1: Visual Analogue Scale (VAS) scores for hunger and fullness.
Timepoint [1] 257675 0
Time points: t= -15, 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] 257676 0
Secondary Outcome 2: Visual Analogue Scale (VAS) scores for thoughts of food and satisfaction.
Timepoint [2] 257676 0
Time points: t= -15, 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 [3] 257677 0
Secondary Outcome 3: Blood analyses.
Response of circulating hormones and other factors associated with appetite regulation including glucose, insulin, lipids including cholesterol, triacylglycerol & FFA's, CCK, leptin, ghrelin, adiponectin, GLP-1 and PYY.
Timepoint [3] 257677 0
Time points: t= -15, 15, 30, 45, 60, 90, 120, 150, 180, 210, 270, 330 and 390 mins. Blood samples will drawn immediately after completion of the VAS at each timepoint. These time points are set assuming t=0 is the time the treatment is administered. Therefore any negative time points refer to a blood sample taken that many minutes before the treatment. Positive time points are for blood samples taken 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)
Normal glucose control (<5.5 mmol/L); liver function; iron studies; lipids; Full blood count (FBC)
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 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 recieve 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 6 treatments in this study. As this is a cross-over trial, each participant will complete all intervention arms in each study.
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
15/10/2009
Actual
15/10/2009
Date of last participant enrolment
Anticipated
Actual
10/03/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 2146 0
New Zealand
State/province [1] 2146 0
Auckland

Funding & Sponsors
Funding source category [1] 243760 0
Commercial sector/Industry
Name [1] 243760 0
Lactopharma
Country [1] 243760 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] 237117 0
University
Name [1] 237117 0
The University of Auckland
Address [1] 237117 0
Human Nutrition Unit, The University of Auckland, 18 Carrick Place, Mt Eden 1024
Country [1] 237117 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243890 0
Northern X Regional Ethics Committee
Ethics committee address [1] 243890 0
3rd floor, Unisys Building 650 Great South Rd Penrose Private Bag 92-522, Wellesley St Auckland
Ethics committee country [1] 243890 0
New Zealand
Date submitted for ethics approval [1] 243890 0
Approval date [1] 243890 0
21/09/2009
Ethics approval number [1] 243890 0
NTX 08/04/036

Summary
Brief summary
A critical factor in the regulation of energy balance is the control of energy intake. Long-term reduction in intake is likely to result in parallel reduction in body weight and adiposity. Long-term maintenance of such a regime however is notoriously difficult to achieve through conscious dieting. Increased consumption of high satiety foods may lead to the subconscious reduction in energy intake and loss of body weight in a large portion of the population unable to consciously restrict their intake to levels matching their expenditure.
Whilst lipids are commonly associated with poor satiety and weight gain relative to other dietary macronutrients, specifically carbohydrate and protein, there is some evidence from investigations into both macro- and micro-lipid components of a hierarchy within the lipid group itself and that specific lipid groups or lipid components may provide useful tools through which higher satiety food products may be developed
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 30304 0
Prof Sally Poppitt
Address 30304 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 30304 0
New Zealand
Phone 30304 0
+6496303744
Fax 30304 0
Email 30304 0
[email protected]
Contact person for public queries
Name 13551 0
Dr Dr Kai Chan
Address 13551 0
Human Nutrition Unit
The University of Auckland,
18 Carrick Place, Mt Eden 1024
Country 13551 0
New Zealand
Phone 13551 0
+ 64 9 630 3744
Fax 13551 0
+ 64 9 630 5764
Email 13551 0
[email protected]
Contact person for scientific queries
Name 4479 0
Prof Sally Poppitt
Address 4479 0
Human Nutrition Unit
The University of Auckland,
18 Carrick Place, Mt Eden 1024
Country 4479 0
New Zealand
Phone 4479 0
+ 64 9 630 5160
Fax 4479 0
+ 64 9 630 5764
Email 4479 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

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