Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000308998
Ethics application status
Approved
Date submitted
21/03/2011
Date registered
23/03/2011
Date last updated
5/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Novel Lipid Emulsions & the effect of particle size on satiety
Scientific title
Dairy Lipid Emulsion Particle Size and the Control of Body Weight. A trial of lean healthy men
Secondary ID [1] 253567 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appetite regulation 261125 0
Condition category
Condition code
Diet and Nutrition 259278 259278 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this trial is to assess the effect of the particle size of orally ingested dairy-derived lipid emulsions on hunger, satiety and energy intake at a single ad libitum meal in human volunteers.
This study involves 4 visits to the Human Nutrition Unit. The first will be a brief screening visit (~30 minutes) where subjects will give their consent & complete questionnaires concerning their medical history, weight loss history & food preferences. We will also gather demographic & anthropometrical data (age, gender, ethnicity, height, weight, body mass index (BMI) and waist & hip circumference). The trial design is a 3 treatment crossover, single day intervention study, comprising 20 lean male subjects (BMI = 18-25kg/m2) aged 18-65 years. At 9am on the morning of each visit subjects will be provided with a yoghurt breakfast containing of one of the 3 dairy treatments (10g emulsion or non-emulsion). Subjects must consume the breakfast meal in full. 3 hours later an ad libitum lunch meal will be provided. There will be a washout period of 3 days between study visit days. Each participant will complete all study arms of the study in a randomized order.

The 3 treatments are:
A = Small particle size dairy lipid/phospholipid emulsion
B = Large particle size dairy lipid/phospholipid emulsion
C = Non-emulsified dairy lipid/phospholipid

The breakfast meals will comprise 10g of the dairy lipid treatment mixed in to a 190g yoghurt (total weight = 200g)

The lunch meal will provide items served in moderate excess & participants will be instructed to eat as much or as little as they like until they feel comfortably full.
Intervention code [1] 264215 0
Treatment: Other
Comparator / control treatment
Non emulsified dairy lipid/phospholipid
Control group
Active

Outcomes
Primary outcome [1] 262324 0
Energy Intake at ad libitum lunch meal. Energy, fat, carbohydrate (CHO) and protein intake will be calculated using the dietary program Foodworks Copyright (c) 1998-2007 Xyris Software.
Timepoint [1] 262324 0
180 minutes post breakfast treatment
Secondary outcome [1] 273543 0
Visual Analogue Scale (VAS) scores for hunger and fullness.
Timepoint [1] 273543 0
t = 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270 and 330 minutes
Secondary outcome [2] 273544 0
Visual Analogue Scale (VAS) scores for thoughts of food and satisfaction.
Timepoint [2] 273544 0
t = 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270 and 330 minutes

Eligibility
Key inclusion criteria
1. male gender
2. aged 18-65y
3. lean (BMI:Causcasian/Indian/Asian 17.5-25kg/m2;Pacific peoples 18.5-26kg/m2)
4. healthy, as ascertained by self-report
5. desire to participate in clinical trial
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. medications that may affect weight/appetite
2. cigarette smoking within previous 6 months
3. unwilling or unable to comply with protocol/ participation in another clinical trial
4. 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 next patient registered is allocated to the sequential randomisation code. Participants are randomized to receive all 3 treatments.
Allocation was not concealed.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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
2/12/2010
Actual
24/01/2011
Date of last participant enrolment
Anticipated
Actual
15/12/2011
Date of last data collection
Anticipated
Actual
15/12/2011
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 3172 0
New Zealand
State/province [1] 3172 0
Auckland

Funding & Sponsors
Funding source category [1] 264662 0
Commercial sector/Industry
Name [1] 264662 0
LactoPharma
Country [1] 264662 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] 263800 0
None
Name [1] 263800 0
Address [1] 263800 0
Country [1] 263800 0
Other collaborator category [1] 251872 0
University
Name [1] 251872 0
The University of Auckland
Address [1] 251872 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024
Country [1] 251872 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266655 0
Northern X Regional Ethics Committee
Ethics committee address [1] 266655 0
3rd floor
Unisys Building
650 Great South Rd Penrose
Private Bag 92-522
Wellesley St Auckland
Ethics committee country [1] 266655 0
New Zealand
Date submitted for ethics approval [1] 266655 0
Approval date [1] 266655 0
22/11/2010
Ethics approval number [1] 266655 0
10/10/0108

Summary
Brief summary
The inability to maintain energy balance is rapidly leading to an epidemic of weight gain and obesity worldwide, as well as nationally within New Zealand (Crowley, Yeo et al. 2002). 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. There is some evidence that lipid emulsions may aid satiety & weight control. A lipid emulsion is a mixture of two or more immiscible liquids. In lipid emulsion products, the lipid component (=dispersed phase) is dispersed in water (=the continuous phase). It has been suggested that the mechanism of action lipid emulsions is the ‘ileal brake’. Nutrient absorption from the proximal intestine is inhibited by the emulsion which then passes unabsorbed through into the distal intestine. It has been hypothesized that this may result in the generation of a peripheral satiety signal (Zhao et al 2000).
Trial website
Trial related presentations / publications
Poppitt SD, Budgett SC, MacGibbon AK, Quek SY, Kindleysides S, Wiessing K. Effects of lipid emulsion particle size on satiety and energy intake. Eur J Clin Nutr 2018;72(3):349-357
Public notes

Contacts
Principal investigator
Name 32189 0
Prof Sally Poppitt
Address 32189 0
Human Nutrition Unit University of Auckland 18 Carrick Place My Eden Auckland 1024
Country 32189 0
New Zealand
Phone 32189 0
+64 9 630 5160
Fax 32189 0
Email 32189 0
[email protected]
Contact person for public queries
Name 15436 0
Miss Katy Wiessing
Address 15436 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
My Eden
Auckland 1024
Country 15436 0
New Zealand
Phone 15436 0
+64 9 630 3744
Fax 15436 0
+64 9 630 5764
Email 15436 0
[email protected]
Contact person for scientific queries
Name 6364 0
Prof Sally Poppitt
Address 6364 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
My Eden
Auckland 1024
Country 6364 0
New Zealand
Phone 6364 0
+64 9 630 5160
Fax 6364 0
+64 9 630 5764
Email 6364 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
EmbaseEffects of lipid emulsion particle size on satiety and energy intake: A randomised cross-over trial.2018https://dx.doi.org/10.1038/s41430-017-0016-7
N.B. These documents automatically identified may not have been verified by the study sponsor.