ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12609000178246

Ethics application status

Approved

Date submitted

23/03/2009

Date registered

17/04/2009

Date last updated

14/11/2018

Date data sharing statement initially provided

14/11/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

The acute effects of whey protein isolate on metabolic syndrome risk factors in overweight and obese individuals

Scientific title

The acute effects of whey protein isolate on metabolic syndrome risk factors in overweight and obese individuals

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Metabolic syndrome risk factors in overweight or obese individuals

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Randomised, single-blind, cross-over design study which invesigates the postprandial response to the acute ingestion of either a liquid preload of 50g of whey protein isolate, casein protein or glucose (control) mixed in 400 mls of water, over 3 visits, one day a week for 3 consecutive weeks.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Placebo - 50g glucose powder (same dose as whey & casein) mixed with 400ml water

Control group

Placebo

Outcomes

Primary outcome [1]

Improved blood lipid and lipoprotein status as well as improved glucose and insulin sensitivity after the ingestion of the whey protein isolate

Timepoint [1]

Fasting blood samples taken before liquid preload and then taken post meal (in minutes) - +15, 30, 60, 90, 120, 180, 240, 360.

Primary outcome [2]

Improved blood pressure after ingestion of the whey protein isolate.Systolic blood pressure (SBP), diastolic blood pressure (DBP) and resting heart rate were measured on the left arm of participants with an automated sphygmomanometer (Dinamap ProCare). Subjects rested in a supine position before and during measurements.

Timepoint [2]

Blood pressure taken before test meal & liquid preload, and then taken post meal (in minutes) - +30, 60, 90, 120, 180, 240, 360.

Primary outcome [3]

Improved vascular endothelial function via Sphygmocor pulse wave analysis (PWA) after the ingestion of the whey protein isolate

Timepoint [3]

PWA readings before test meal & liquid preload, then post meal (in minutes) - 30, 60, 90, 120, 180, 240, 360.

Secondary outcome [1]

Greater satiety after ingesting the whey protein isolate relative to control.

Timepoint [1]

Visual analogue scale (VAS) completed by subjects before test meal & liquid preload, and then post meal (in minutes) - 30, 60, 90, 120, 180, 240, 360.

Eligibility

Key inclusion criteria

Post-menopausal
Non-smoker
Body mass Index (BMI) between 25-35 kg/m2
Not taking regular medication
Not taking supplements, vitamins or herbal remedies
Weight stable
Less than 1-2 serves dairy per day
No major diseases/illness

Minimum age

45 Years

Maximum age

65 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Smokers
Regular medications, especially those affecting blood lipids, blood pressure or thyroid
Premenopausal or perimenopausal
On a weight loss regime

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)

Numbered containers

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Three-way crossover design

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/03/2009

Actual

5/03/2009

Date of last participant enrolment

Anticipated

Actual

7/07/2009

Date of last data collection

Anticipated

Actual

21/07/2009

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Dairy Australia

Address [1]

Locked Bag 104
Flinders Lane
Victoria 8009

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Dairy Australia

Address

Locked Bag 104
Flinders Lane
Victoria 8009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Ethics Commitee

Ethics committee address [1]

GPO BOX U1987
Perth WA 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/11/2007

Approval date [1]

11/12/2007

Ethics approval number [1]

HR 131/2007

Summary

Brief summary

The prevalence of overweight/obesity is currently exploding with over 60% of Australian adults in this category, leading to a rapid increase in diabetes, hypertension, and cardiovascular disease (CVD). Increased dairy consumption has been demonstrated to significantly benefit weight loss. Initially, it was thought that diary calcium was the reason for these health benefits, but recent studies have shown that this is not the case. Attention is now focused to other dairy components, such as dairy proteins. Although there is no clinical evidence in humans to support this, exciting new research from animal studies have shown that dairy whey-protein isolate (WPI) can reduce body weight, lower plasma lipids, improve, blood pressure and insulin action. There is an urgent need to provide the scientific evidence to clarify whether the protein component is responsible for the observed association between dairy consumption and body weight. Therefore the aim of this study was to investigate whether acute ingestion of WPI affects postprandial lipemia, insulin sensitivity and endothelial function in overweight/obese adults.

Trial website

Trial related presentations / publications

Pal S, Ellis V, Ho S. Acute effects of whey protein isolate on cardiovascular risk factors in overweight, post-menopausal women. Atherosclerosis. 2010;212(1):339-44

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Assoc Prof Sebely Pal

Address

Curtin University
GPO Box U1987
Perth WA 6845

Country

Australia

Phone

+61 8 9266 4755

Fax

[email protected]

Contact person for scientific queries

Name

Assoc Prof Sebely Pal

Address

Curtin University
GPO Box U1987
Perth WA 6845

Country

Australia

Phone

+61 8 9266 4755

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Dimensions AI	Acute effects of whey protein isolate on blood pressure, vascular function and inflammatory markers in overweight postmenopausal women	2011	https://doi.org/10.1017/s0007114510005313

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically