Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000723280
Ethics application status
Approved
Date submitted
9/03/2009
Date registered
24/08/2009
Date last updated
21/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Whey proteins and satiety: the effects of beverages supplemented with dairy whey proteins on hunger, satiety and energy intake in a group of overweight women
Scientific title
Dairy fractions and satiety: the effects of dairy beverages on post-ingestive hunger, satiety and energy intake in a group of overweight women
Secondary ID [1] 287505 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/Obesity 4437 0
Condition category
Condition code
Diet and Nutrition 4705 4705 0 0
Other diet and nutrition disorders
Diet and Nutrition 239821 239821 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, randomised, cross-over study in overweight/obese women (Body Mass Index (BMI) 25-32kg/m2). This study is in two parts and will investigate (i) the effect of dairy beverages compared with zero energy water beverages, using a dose-escalating 4 treatment design, and (ii) the effect of dairy beverages compared with carbohydrate (CHO) -containing beverages, using a dose-escalating 6 treatment design. Both studies will be carried out using identical protocols and participant groups. A single test beverage (500ml) will be given on each study day. The trial beverages will be administered after a standardised evening meal and a standardised breakfast meal. The evening meal to be consumed the night before each treatment day (between 6-9pm) and the breakfast meal provided on the morning of the treatment are given in an attempt to minimise any carry-over effects of foods consumed prior to the intervention. The evening meals are given to the participants at their screen visit or study visit with clear instructions on how to store the meal and also how to prepare it. The breakfast meal is provided at the Human Nutrition Unit on the morning of the intervention at 9am. 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 120 minutes after the test beverage. Study visits to be separated by a wash-out period of at least 3 days.

Test Beverages:

Study 1 Dairy Beverage Dose Escalation Study:
Control zero energy water beverage (0g dairy whey protein).
Low dose (1%, 5g dairy whey protein)
Medium dose (2%, 10g dairy protein), and
High dose (4%. 20g dairy whey protein)dairy beverages.
Participants will be ramdomized to recieve all 4 beverages detailed above over 4 study days. There must be at least 3 days between study visits. Participants are free to choose which days they come in to the unit so the study duration will be from 2 weeks to a couple of months if participants can only come in one day per week.

Study 2 Dairy Beverage vs CHO Study: Control zero energy water beverage (0g dairy whey protein; 0g CHO)
Medium (2%, 10g dairy protein), and
High dose (4%, 20g dairy protein) dairy beverages.
Low (2%, 10g CHO)
Medium (4%, 20g CHO), and
High dose (10%, 50g CHO) carbohydrate beverages.

Participants will be ramdomized to recieve all 6 beverages detailed above over 6 study days. There must be at least 3 days between study visits. Participants are free to choose which days they come in to the unit so the study duration will be from 3 weeks to a few months if participants can only come in one day per week.
The protein component will consist of a whey protein and the carbohydrate will be
sucrose (=table sugar).

Participants may take part in both study 1 and study 2. Participants may also just partcipate in either study 1 or study 2.

If participants do wish to take part in both studies the minimum washout period between the studys is 3 days.
Intervention code [1] 4183 0
Treatment: Other
Comparator / control treatment
Control Beverage: Zero energy, artificially sweetened, flavoured water
Control group
Placebo

Outcomes
Primary outcome [1] 5573 0
Primary Outcome 1: 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] 5573 0
Timepoint: 120 minutes post-test beverage
Secondary outcome [1] 9384 0
Secondary Outcome 1: Visual Analogue Scale (VAS) scores for hunger and fullness
Timepoint [1] 9384 0
Timepoints: t= -125, -105, -5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 mins.

These time points are set assuming t=0 is the time beverage comsumption commences. Therefore any negative timepoints refer to a VAS measurement taken that many minutes beftore the beverage is consumed. Positive timepoints are for VAS measurements at that number of minutes after the beverage consumption commences.
Secondary outcome [2] 9385 0
Secondary Outcome 2: Visual Analogue Scale (VAS) scores for satisfaction and thoughts of food
Timepoint [2] 9385 0
Timepoints: t= -125, -105, -5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 mins

These time points are set assuming t=0 is the time beverage comsumption commences. Therefore any negative timepoints refer to a VAS measurement taken that many minutes beftore the beverage is consumed. Positive timepoints are for VAS measurements at that number of minutes after the beverage consumption commences.

Eligibility
Key inclusion criteria
Female
Age 18-45 years
Overweight/mild obesity, as defined by BMI 25-32 kg/m2
Unrestrained eater as defined by the 3 Factor Eating Questionnaire (Stunkard & Messick, 1985)
Healthy, as ascertained by self-report
Signed consent given
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Endocrine, cardiovascular, gastrointestinal, metabolic disease or cancer/s including a history of these diseases as determined by the study physician.
Pregnant or breast-feeding.
Smoker or ex-smoker who quit within the last 6 months.
Weight loss/gain of > 10% body weight within the last 6 months, as per self report.
Actively taking part in a diet programme such as Jenny Craig, Weight Watchers, Slim Sure, Atkins Diet, South Beach Diet.
Taking any medications for weight loss or other medications known to affect appetite regulation.
Any medical conditions known to affect appetite related research parameters.
Depression or any other anxiety disorder known to affect appetite.
Hypersensitivities or allergies to any foods or ingredients included in the study.
Restrained eater, as assessed from 3 Factor Eating Questionnaire (Stunkard & Messick, 1985).
Dislike or can not eat any of the foods offered as part of the within the evening meal, breakfast or buffet.
Unwilling/unable to comply with study protocol.
Participating in another clinical intervention trial.

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 double-blind, randomised, cross-over trial. The test beverages are labelled using code numbers, as supplied by the sponsor. Randomisation is carried out using a latin square design, whereby next patient registered is allocated to the sequential randomisation code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A latin square will be used to (i) randomise the subjects into 4 treatments in Study 1 and (ii) randomise the subjects into 6 treatments in Study 2. As this is a cross-over trial, each participant will complete all intervention arms in each study.
Masking / blinding
Blinded (masking 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
23/09/2008
Actual
27/08/2008
Date of last participant enrolment
Anticipated
Actual
30/03/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
110
Recruitment outside Australia
Country [1] 1658 0
New Zealand
State/province [1] 1658 0
Auckland

Funding & Sponsors
Funding source category [1] 4630 0
Commercial sector/Industry
Name [1] 4630 0
Fonterra Co-operative Group Ltd
Country [1] 4630 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra Co-operative Group Ltd
Address
Dairy Farm Road, Private Bag 11 029
Palmerston North, New Zealand
Country
New Zealand
Secondary sponsor category [1] 4174 0
University
Name [1] 4174 0
The University of Auckland
Address [1] 4174 0
Human Nutrition Unit
The University of Auckland
18 Carrick Place, Mt Eden 1024
Country [1] 4174 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6669 0
Northern X Regional Ethics Committee
Ethics committee address [1] 6669 0
Ethics committee country [1] 6669 0
New Zealand
Date submitted for ethics approval [1] 6669 0
Approval date [1] 6669 0
21/08/2008
Ethics approval number [1] 6669 0
NTX08/07/065

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

Contacts
Principal investigator
Name 29365 0
Prof Sally Poppitt
Address 29365 0
University of Auckland Human Nutrition Unit
18 Carrick Place
Mt Eden
Auckland 1024
Country 29365 0
New Zealand
Phone 29365 0
+6496303744
Fax 29365 0
Email 29365 0
[email protected]
Contact person for public queries
Name 12612 0
Kai Chan
Address 12612 0
Human Nutrition Unit, The University of Auckland,
18 Carrick Pl, Mt Eden,
Auckland 1024
Country 12612 0
New Zealand
Phone 12612 0
+64 9 6303744
Fax 12612 0
+64 9 6305764
Email 12612 0
[email protected]
Contact person for scientific queries
Name 3540 0
Sally Poppitt
Address 3540 0
Human Nutrition Unit, The University of Auckland,
18 Carrick Pl, Mt Eden,
Auckland 1024
Country 3540 0
New Zealand
Phone 3540 0
+64 9 6305160
Fax 3540 0
+64 9 6305764
Email 3540 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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