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Trial registered on ANZCTR


Registration number
ACTRN12611000312943
Ethics application status
Approved
Date submitted
23/03/2011
Date registered
24/03/2011
Date last updated
10/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Milk fractions and metabolic syndrome markers
Scientific title
Milk Fractions for the Treatment of Metabolic Dysregulation in Obesity
Secondary ID [1] 252316 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 252354 0
Condition category
Condition code
Diet and Nutrition 256543 256543 0 0
Obesity
Metabolic and Endocrine 257993 257993 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the potential of two dairy derived extracts to improve symptoms of the Metabolic Syndrome, including fatty liver, serum lipid and glucose profiles & markers of inflammation, in individuals with the Metabolic Syndrome. The target population would be individuals identified as overweight with central adiposity, metabolic syndrome, abnormal liver function and fatty liver as shown by an ultrasound scan.

Participants will be randomised to recieve one of the 2 dairy fractions or a control for a period of 3 weeks, followed by a minimum 3 weeks wash out period between active treatments or control. All participants will complete the three treatment arms.

The dairy fractions differ from each other in that one is a high-carbohydrate fraction while the other is a high-lipid (fat) fraction. The dose of the carbohydrate fraction is 10g/day (138kJ) while the dose of the lipid fraction is 4g/day (138kJ). The doses were selected so as to match treatments for total energy (kJ). The dose of the control treatment is 6.5g/day (138kJ).

The administration vehicle for this study will be a chocolate dairy dessert. All treatments will be incorporated into 150g fresh dessert and consumed daily.
Intervention code [1] 255668 0
Treatment: Other
Comparator / control treatment
The control in this study is commercial whole milk powder (WMP). The dose of the control treatment is 6.5g/day (138kJ).
Control group
Active

Outcomes
Primary outcome [1] 253428 0
Changes in blood markers of obesity-induced metabolic dysregulation: Fasting lipids [triacylglyceride (TAG), total cholesterol, low density lipoprotein cholecterol (LDL-C) & high density lipoprotein cholesterol (HDL-C)]. Blood samples will be collected via phlebotomy for analyses
Timepoint [1] 253428 0
At the end of each 3 week treatment period (day 21)
Secondary outcome [1] 262551 0
Changes in blood markers of liver function including Aspartate transaminase (AST), Alanine transaminase (ALT) & Gamma glutamyl transpeptidase (GGT). Blood samples will be collected via phlebotomy for analyses
Timepoint [1] 262551 0
At the end of each 3 week treatment period (day 21)
Secondary outcome [2] 262552 0
Fasting blood glucose & fasting insulin. Blood samples will be collected via phlebotomy for analyses
Timepoint [2] 262552 0
At the end of each 3 week treatment period (day 21)

Eligibility
Key inclusion criteria
1. Male gender
2. Age 18-70 years
3. BMI: >25 kg/m2
4. Central obesity (waist circumference >94 cm for Europeans or >90cm for Indian & Asian Ethnic groups).
5. Abnormal liver function tests as indicated by raised liver enzyme above normal range [normal range: AST 0-45 IU/L, ALT 0-45 IU/L, GGT 0-60 IU/L]
6. Plus any one of the following adverse metabolic syndrome markers [Triglyceride >1.7mmol/L; HDL- Cholesterol <1.03mmol/L; Glucose >5.4mmol/L;
Blood Pressure >130/85mmHg]
7. Fatty liver as determined by an ultrasound scan
8. Change in body weight of <10 kg within the past 6 months, as per self report.
9. Willingness to participate in a clinical trial
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Allergy to milk or dairy products
2. Endocrine, cardiovascular, gastrointestinal (including liver), metabolic disease or cancer/s including prior history
3. Known hepatitis or other liver disease
4. Significant renal impairment based on serum creatinine >120umol/L, estimated Glomerular Filtration Rate (eGFR) < 60ml/min/1.73m2 , and raised microalbuminurea
5. Current treatment for metabolic disease including hypertension, hyperlipidemia, Type 2 Diabetes Mellitus and gout.
6. Alcohol intake exceeding >30g a day or >210g weekly (ie. >3 standard drinks a day or >21 standard drinks a week) indicative of alcoholic fatty liver disease
7. Unwilling/unable to comply with study protocol
8. Participation 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 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 is 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?



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
29/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2356 0
New Zealand
State/province [1] 2356 0
Auckland

Funding & Sponsors
Funding source category [1] 256146 0
Commercial sector/Industry
Name [1] 256146 0
LactoPharma
Country [1] 256146 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] 251489 0
None
Name [1] 251489 0
Address [1] 251489 0
Country [1] 251489 0
Other collaborator category [1] 992 0
University
Name [1] 992 0
University of Auckland
Address [1] 992 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024
Country [1] 992 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258240 0
Northern X Regional Ethics Committee
Ethics committee address [1] 258240 0
3rd floor
Unisys Building
650 Great South Rd Penrose 1061
Private Bag 92-522
Wellesley St Auckland
Ethics committee country [1] 258240 0
New Zealand
Date submitted for ethics approval [1] 258240 0
Approval date [1] 258240 0
11/02/2010
Ethics approval number [1] 258240 0

Summary
Brief summary
Metabolic syndrome (Met Syn) is the combination of metabolic disorders that increase the risk of developing CVD and Type 2 Diabetes Mellitus. The MetSyn cluster is characterized by central adiposity, adverse lipid and glucose profiles and hypertension (Alberti KG et al 2009). Other metabolic abnormalities that may be drivers of the events or develop in parallel include increases in pro-inflammatory profile, disordered blood clotting and lipid ‘overspill’ from adipose into critical organs such as liver, heart and muscle. Nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) are highly prevalent diseases that accompany obesity and the MetSyn (McKimmie RL et al 2008).
A battery of in vitro investigations and preclinical rodent studies investigating the effect of bovine milk fractions on metabolic syndrome outcomes has led to the selection of 2 milk fractions to be taken forwards into clinical investigation for the treatment of obesity-related metabolic dysregulation. The in vitro and preclinical studies have been conducted by a collaborative group of researchers working within the LactoPharma NZ consortium, a joint venture between the NZ Foundation of Research Science & Technology (FRST) and dairy company Fonterra Co-Operative Group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30592 0
Address 30592 0
Country 30592 0
Phone 30592 0
Fax 30592 0
Email 30592 0
Contact person for public queries
Name 13839 0
Katy Wiessing
Address 13839 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
My Eden
Auckland 1024
Country 13839 0
New Zealand
Phone 13839 0
+ 64 9 630 3744
Fax 13839 0
+ 64 9 630 5764
Email 13839 0
[email protected]
Contact person for scientific queries
Name 4767 0
Dr Sally Poppitt
Address 4767 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
My Eden
Auckland 1024
Country 4767 0
New Zealand
Phone 4767 0
+ 64 9 630 5160
Fax 4767 0
+ 64 9 630 5764
Email 4767 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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