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Trial registered on ANZCTR


Registration number
ACTRN12611001013954
Ethics application status
Approved
Date submitted
21/09/2011
Date registered
21/09/2011
Date last updated
10/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of dairy-derived proteins on circulating lipids and related cardiovascular risk factors in mildly hypercholesterolaemic individuals
Scientific title
A placebo controlled, cross-over trial investigating the effect of dairy-derived proteins on circulating lipids and related cardiovascular risk factors in mildly hypercholesterolaemic individuals
Secondary ID [1] 263058 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypercholesterolaemia 270792 0
Condition category
Condition code
Diet and Nutrition 270980 270980 0 0
Other diet and nutrition disorders
Cardiovascular 270981 270981 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a double blind, randomised, placebo controlled, cross-over, out-patient trial in a group of 25 mildly hypercholesterolaemic male volunteers aged 18 - 70 years. Participants were randomised to receive either the active treatment or placebo for a period of 3 weeks, followed by a minimum washout period of 3 weeks, and were then crossed-over onto the second 3 week period of active treatment or placebo.
Participants came to the Human Nutrition Unit (HNU) on 7 occasions. At the first visit (visit 1) they gave their informed consent and were registered to the study. At this visit the participant’s height, weight and blood pressure were measured and fasting blood and urine samples were taken for analyses. Information concerning medications and their medical history was recorded.
Both treatment arms followed the same protocol. At visits 2 and 3 (days 0, 1; baseline) weight and blood pressure were measured and baseline fasting blood and urine samples were collected. Adverse events and changes in medications were recorded if applicable. Participants were given a week’s supply of treatment or placebo at visit 2 (depending on the randomization) to be taken daily.
At visits 4 - 7 (days 7, 14, 21, 22) compliance to the treatment/placebo was checked, weight and blood pressure were measured, a fasting blood sample was collected and adverse events and changed in medications were recorded. At visit 22 a fasting urine sample was also collected.


Treatments:
The active treatment was a dairy-derived peptic casein hydrolysate, at a dose of 10g/day (=0.42MJ)
The placebo was a dairy-derived whey protein control, at a matched dose of 10g/day (=0.42MJ)
The treatments were administered as 1000mg capsules. 10 capsules were to be taken orally daily with breakfast.
Intervention code [1] 269407 0
Treatment: Other
Comparator / control treatment
The placebo was a dairy-derived whey protein control, at a matched dose of 10g/day (=0.42MJ)
Control group
Placebo

Outcomes
Primary outcome [1] 279650 0
Changes in fasting circulating low density lipoprotein (LDL) cholesterol concentration. Blood samples will be collected via phlebotomy for analyses
Timepoint [1] 279650 0
At the end of each 3 week treatment (day 21/22)
Secondary outcome [1] 294123 0
Changes in cardiovascular related markers including urine uric acid, blood pressure, total cholesterol, high density lipoprotein (HDL) cholesterol, triacylglyceride (TAG), glucose and insulin. Blood samples will be collected via phlebotomy for analyses.
Timepoint [1] 294123 0
At the end of each 3 week treatment (day 21/22)

Eligibility
Key inclusion criteria
1. mild hypercholesterolaemia; fasted LDL-C > 3.0 mmol/L
2. no clinical intervention or drug treatment for hyperlipidaemia
3. no previous cardiovascular events
4. no evidence of end organ damage
5. willingness to participate in a clinical trial
Minimum age
18 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. allergy to milk or dairy products
2. treatment for lipid disorders
3. treatment for hypertension
4. significant metabolic disorders, including diabetes mellitus, significant renal impairment (serum creatinine>130mmol/L; EGFR<60) or other disease
5. gout
6. 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 both the active treatment and placebo. 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 2 intervention arms. Each participant is randomized to complete both 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)
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 outside Australia
Country [1] 3847 0
New Zealand
State/province [1] 3847 0
Auckland

Funding & Sponsors
Funding source category [1] 269880 0
Commercial sector/Industry
Name [1] 269880 0
LactoPharma
Address [1] 269880 0
Fonterra Centre
9 Princes Street
Private Bag 92032
Auckland 1010
Country [1] 269880 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
LactoPharma
Address
Fonterra Centre
9 Princes Street
Private Bag 92032
Auckland1010
Country
New Zealand
Secondary sponsor category [1] 268896 0
University
Name [1] 268896 0
University of Auckland
Address [1] 268896 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024
Country [1] 268896 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271849 0
Northern X Regional Ethics Committee
Ethics committee address [1] 271849 0
3rd floor
Unisys Building
650 Great South Rd Penrose 1061
Private Bag 92-522
Wellesley St Auckland
Ethics committee country [1] 271849 0
New Zealand
Date submitted for ethics approval [1] 271849 0
Approval date [1] 271849 0
09/07/2007
Ethics approval number [1] 271849 0
NTX/07/03/027

Summary
Brief summary
Cardiovascular disease (CVD) is one of the leading causes of mortality in developed countries accounting for as many as 12 million deaths per year. Many risk factors contribute to the development of CVD, a number of which are modifiable such as obesity, blood pressure and lipid profile (Expert Panel on Detection 1993; Grundy 2002).
A number of dietary components have been shown to improve serum cholesterol levels in both animal and human studies. The most consistent and positive relationship is between intake of lipids and CVD risk, where intake of dietary saturated fats is closely associated with adverse serum cholesterol levels and increased CVD mortality (Hegsted, McGandy et al. 1965; Keys 1970; McGee, Reed et al. 1984; Kushi, Lew et al. 1985; Grundy and Vega 1988; Posner, Cobb et al. 1991; Caggiula and Mustad 1997; Poppitt, Keogh et al. 2002).
Less is known of cholesterol-lowering effects of protein or protein fractions. Animal studies carried out by our research team have identified a number of milk proteins which may have significant cholesterol-lowering effects in humans. In particular, the dairy protein fraction casein hydrolysed using a peptic hydrolysate was shown to improve total cholesterol in a study of Apo E deficient mice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33169 0
Address 33169 0
Country 33169 0
Phone 33169 0
Fax 33169 0
Email 33169 0
Contact person for public queries
Name 16416 0
Katy Wiessing
Address 16416 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024
Country 16416 0
New Zealand
Phone 16416 0
+ 64 9 630 3744
Fax 16416 0
+ 64 9 630 5764
Email 16416 0
k.wiessing@uniservices.auckland.ac.nz
Contact person for scientific queries
Name 7344 0
Dr Sally Poppitt
Address 7344 0
Human Nutrition Unit
University of Auckland
18 Carrick Place
Mt Eden
Auckland 1024
Country 7344 0
New Zealand
Phone 7344 0
+ 64 9 630 5160
Fax 7344 0
+ 64 9 630 5764
Email 7344 0
s.poppitt@auckland.ac.nz

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