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Trial registered on ANZCTR


Registration number
ACTRN12608000510347
Ethics application status
Approved
Date submitted
4/09/2008
Date registered
30/09/2008
Date last updated
23/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of skim milk in comparison to a fruit juice beverage on satiety and energy intake in overweight men and women
Scientific title
Effects of skim milk in comparison to a fruit juice beverage on satiety and energy intake in overweight men and women
Secondary ID [1] 283442 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight men and women 3643 0
Condition category
Condition code
Diet and Nutrition 3807 3807 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a randomised, controlled, cross-over trial investigating the acute effects of skim milk on post-meal satiety and energy intake. Each participant will undertake 2 visits in random order, 1 week apart on the same day at the same time of day. Participants will be fasting at each visit. They will consume either 600 mL of skim milk (1122 kJ; 27 g protein), or 600 mL of a sugar-based fruit juice beverage (1122 kJ; <1 g protein) with a fixed energy breakfast (1000 kJ). Participants will consume the beverage over a 15 minute period. Four hours after breakfast, they will be provided with an ad libitum lunch consisting of previously selected sandwiches. They will be asked to eat the sandwiches, which will be available in excess, until they are comfortably full. They will be permitted to consume one cup of coffee, tea, or a glass of water 2 h after breakfast and with the lunch meal. 45 minutes will be allowed for lunch. At the completion of lunch, energy intake will be assessed.
Intervention code [1] 3357 0
Other interventions
Comparator / control treatment
Sugar-based fruit juice beverage
Control group
Active

Outcomes
Primary outcome [1] 4706 0
4 hour Post-breakfast energy intake at lunch.
Timepoint [1] 4706 0
Energy intake will be measured by weighing foods prior to lunch and following completion of the lunch meal.
Primary outcome [2] 4783 0
Satiety measured by questionnaire using visual analogue scales as described by Flint et al (International Journal of Obesity 2000;24:38-48).
Timepoint [2] 4783 0
Questionnaires administered at baseline (time=0) and at 30, 60, 120, 180, 210 and 240 minutes post-breakfast, as well as immediately after lunch.
Secondary outcome [1] 7946 0
Palatibility of beverage by questionnaire using visual analogue scales as described by Flint et al (International Journal of Obesity 2000;24:38-48).
Timepoint [1] 7946 0
Questionnaire administered at baseline (time=0).

Eligibility
Key inclusion criteria
Overweight /obese, but otherwise healthy, men and women.
Minimum age
25 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current or recent (<12 months) smoking; body mass index < 27 or > 37 kg/m2; history of cardiovascular or peripheral vascular disease; diagnosed diabetes, and non-diabetic individuals with fasting plasma glucose concentrations greater than or equal to 5.5 mmol/L; psychiatric illness; other major illnesses such as cancer; current or recent (< 6 months) significant weight loss or gain (> 6% of body weight);
alcohol intake > 210 g per week for women and > 280 g per week for men; inability or unwillingness to consume beverages provided.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation by a statistician not involved with the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3820 0
Commercial sector/Industry
Name [1] 3820 0
Fonterra Brands Ltd, New Zealand
Address [1] 3820 0
Private Bag 11029
Palmerston North
Country [1] 3820 0
New Zealand
Primary sponsor type
Individual
Name
Professor Trevor A Mori
Address
School of Medicine and Pharmacology
GP Box X2213
Perth WA 6847
Country
Australia
Secondary sponsor category [1] 3433 0
Individual
Name [1] 3433 0
Dr Jonathan Hodgson
Address [1] 3433 0
School of Medicine and Pharmacology
GP Box X2213
Perth WA 6847
Country [1] 3433 0
Australia
Other collaborator category [1] 400 0
Individual
Name [1] 400 0
Professor Ian Puddey
Address [1] 400 0
School of Medicine and Pharmacology
GP Box X2213
Perth WA 6847
Country [1] 400 0
Australia
Other collaborator category [2] 401 0
Individual
Name [2] 401 0
Professor Lawrence Beilin
Address [2] 401 0
School of Medicine and Pharmacology
GP Box X2213
Perth WA 6847
Country [2] 401 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5879 0
University of Western Australia
Ethics committee address [1] 5879 0
Ethics committee country [1] 5879 0
Australia
Date submitted for ethics approval [1] 5879 0
Approval date [1] 5879 0
28/03/2008
Ethics approval number [1] 5879 0
RA/4/1/1200

Summary
Brief summary
Overweight and obesity impact on the risk of diabetes, hypertension and cardiovascular disease. Emerging data suggest that nutrient composition of the diet is an important factor controlling satiety and energy intake, and that dietary protein is the most satiating nutrient. Skim milk is an excellent source of protein. Sweetened drinks rich in sucrose and/or glucose and fructose have become increasingly popular, and evidence suggests they may contribute to positive energy balance and the development of obesity. Skim milk has similar energy density to many sweetened drinks, but almost half the energy is present as protein. Indirect evidence suggests that skim milk (high in protein) relative to a sugar beverage, should reduce energy intake acutely.
The study aims to investigate the effects of drinking skim milk in comparison to a fruit juice beverage, at breakfast on self-reported post-meal satiety and energy intake at lunch, in overweight individuals.
Trial website
Trial related presentations / publications
Dove ER, Hodgson JM, Puddey IB, Beilin LJ, Lee YP, Mori TA. Skim milk compared to a fruit drink reduces appetite and energy intake acutely in overweight men and women. The American Journal of Clinical Nutrition 2009; 90: 70–5.

Effects of skim milk in comparison to a fruit juice beverage on satiety and energy intake in overweight men and women.
Dove ER, Hodgson JM, Puddey IB, Beilin LJ, Mori TA.
2008 Obesity Society Annual Scientific Meeting, Brisbane, 20-22 November 2008.
Public notes

Contacts
Principal investigator
Name 28899 0
Prof Trevor Mori
Address 28899 0
School of Medicine and Pharmacology, Royal Perth Hospital, GPO Box X2213 Perth WA 6847
Country 28899 0
Australia
Phone 28899 0
+61892240273
Fax 28899 0
Email 28899 0
trevor.mori@uwa.edu.au
Contact person for public queries
Name 12056 0
Prof Professor Trevor A Mori
Address 12056 0
School of Medicine and Pharmacology
GP Box X2213
Perth WA 6847
Country 12056 0
Australia
Phone 12056 0
61-8-9224 0273
Fax 12056 0
61-8-9224 0246
Email 12056 0
trevor.mori@uwa.edu.au
Contact person for scientific queries
Name 2984 0
Prof Professor Trevor A Mori
Address 2984 0
School of Medicine and Pharmacology
GP Box X2213
Perth WA 6847
Country 2984 0
Australia
Phone 2984 0
61-8-9224 0273
Fax 2984 0
61-8-9224 0246
Email 2984 0
trevor.mori@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary