Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000450314
Ethics application status
Approved
Date submitted
9/09/2008
Date registered
15/09/2008
Date last updated
15/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Protein StudyThe effect of protein intake on circulating inflammatory markers in women with obesity
Scientific title
The effect of protein intake on circulating inflammatory markers in women with obesity
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory markers and insulin secretion in obese women after ingestion of protein, protein and carbohydrate meals, or carbohydrate only meals 3009 0
Condition category
Condition code
Metabolic and Endocrine 3160 3160 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants consume 2 protein meals consisting of 19.5gms of dairy protein per meal. The meals are consumed on 2 different occasions with an interval of at least 1 week between the meals.
Intervention code [1] 2749 0
Lifestyle
Comparator / control treatment
All participants consume 1 no protein meal. This meal is carbohydrate only and is consumed on 1 occasion, with at least a 1 week interval between the other meals (protein meals)
Control group
Active

Outcomes
Primary outcome [1] 4723 0
Whether ingestion of protein and especially dairy protein, increases the secretion of insulin and thus it's anti-inflammatory activity. The plasma insulin secretion will be measured using a commercial kit (Roche) on a Hitachi E170 autoanalyser.
Timepoint [1] 4723 0
The insulin levels will be measured at baseline, 1 hour and 4 hour intervals after consuming the meals.
Primary outcome [2] 4724 0
Markers of inflammation-Plasma levels of IL-6, will be measured by Enzyme-Linked ImmunoSorbent Assay (ELISA) using a commercial kit (R&D Systems) Plasma Free fatty acid levels will be measured using a commercial kit from Roche Diagnostics.
Timepoint [2] 4724 0
All these blood samples will be taken at baseline, 1 hour and 4 hours after the meal.
Secondary outcome [1] 7971 0
Plasma Glucose will be measured by a routine method in the hospital diagnostic laboratory.
Timepoint [1] 7971 0
All these blood samples will be taken at baseline, 1 hour and 4 hours after the meal.

Eligibility
Key inclusion criteria
25 abdominally obese women Body Mass Index (BMI) > 30 and waist circumference > 88cm)
Minimum age
30 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Cigarette smoking, cardiovascular disease, infections or other serious medical problems and use of some medications

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)
Subjects will be recruited by advertising, then if eligible, enrolled in the study and randomly allocated to treatment. The treatment allocation schedule will be held by an independant person
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each subject who meets the selection criteria after screening will be randomised to one of 6 sequences of the 3 meals in in a Latin square design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Comparison of 3 different meals
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 861 0
New Zealand
State/province [1] 861 0
Otago

Funding & Sponsors
Funding source category [1] 3837 0
Charities/Societies/Foundations
Name [1] 3837 0
Novo Nordisk New Zealand Diabetes Grant Scheme
Country [1] 3837 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Medicine
9th floor
Dunedin Hospital
201 Great King Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 3448 0
None
Name [1] 3448 0
Address [1] 3448 0
Country [1] 3448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5891 0
Lower South Regional Ethics Committee
Ethics committee address [1] 5891 0
229 Moray Place
Dunedin 9016
Ethics committee country [1] 5891 0
New Zealand
Date submitted for ethics approval [1] 5891 0
Approval date [1] 5891 0
27/05/2008
Ethics approval number [1] 5891 0
LRS/08/03/006

Summary
Brief summary
Pro-inflammatory cytokines concentrations are elevated in the fasting and postprandial state and are thought to contribute to the high risk of insulin resistance and type 2 diabetes in obesity. Ingestion of protein and especially dairy protein, increases the secretion of insulin that has anti-inflammatory activity. The study aims to determine whether ingestion of dairy protein with or without carbohydrate decreases postprandial levels of pro-inflammatory cytokines in obese women. The findings will be highly relevant to the use of high -protein diets in the management of obesity and type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28500 0
Address 28500 0
Country 28500 0
Phone 28500 0
Fax 28500 0
Email 28500 0
Contact person for public queries
Name 11657 0
Associate Clinical Professor Patrick Manning
Address 11657 0
Department of Medical and Surgical Sciences
Dunedin School of Medicine
PO BOX 913
Dunedin 9054
Country 11657 0
New Zealand
Phone 11657 0
+64 3 4740999
Fax 11657 0
+64 3 4709500
Email 11657 0
[email protected]
Contact person for scientific queries
Name 2585 0
Dr Wayne Sutherland
Address 2585 0
Medicine Section
Department of Medical and Surgical Sciences
Dunedin School of Medicine
PO BOX 913
Dunedin 9054
Country 2585 0
New Zealand
Phone 2585 0
+64 3 4640999
Fax 2585 0
+64 3 4747641
Email 2585 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.