Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12615000164594 |
Date of registration:
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19/02/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Acute effects of red meat and dairy on glucose metabolism
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Scientific title:
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The acute effect of a high red meat diet and a high dairy diet on glucose metabolism in overweight and obese adults with normal and with impaired glucose tolerance as measured by meal tolerance tests. |
Date of first enrolment:
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01/12/2014 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12615000164594.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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A/Prof Jennifer Keogh
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Address:
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University of South Australia
PO BOX 2471
Adelaide SA 5000
Australia |
Telephone:
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+61 8 8302 2579 |
Email:
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jennifer.keogh@unisa.edu.au |
Affiliation:
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Name:
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A/Prof Jennifer Keogh
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Address:
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University of South Australia
PO BOX 2471
Adelaide SA 5000
Australia |
Telephone:
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+61 8 8302 2579 |
Email:
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jennifer.keogh@unisa.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Men and women with a BMI >25, with normal glucose tolerance or with impaired fasting glucose or impaired glucose tolerance.
Exclusion criteria: Major metabolic illness such as kidney or liver disease; type 2 diabetes; anyone on drugs influencing glucose metabolism (eg Metformin).
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Metabolic and Endocrine - Diabetes
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Insulin sensitivity; Insulin sensitivity
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Diet and Nutrition - Obesity
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Intervention(s)
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A crossover meal study will be performed to evaluate the acute effects of red meat and dairy on glucose and insulin levels. Two isoenergetic test meals, equal in protein, carbohydrate and fat content, with one meal containing red meat and the other containing dairy products will be consumed by each participant on two separate occasions, one week apart. The red meat meal is made up of 90g beef, 59g bread, 13g butter and 250g of orange juice. The dairy meal is made up of 260g milk, 75g yoghurt, 36g cheese, 62g bread and 11g margarine. Overweight and obese adults (BMI >25) over the age of 20 will be recruited for this study. They will be separated into two groups; normal glucose tolerance and impaired glucose tolerance, as established by a 75g OGTT performed at the baseline visit, or from a previous medical diagnosis of impaired glucose tolerance. Participants will attend on three occasions following an overnight fast. The first visit is a screening visit and participants will have their fasting blood glucose concentrations determined from capillary whole blood. A 75g OGTT will be conducted, with a second glucose concentration measured 120 minutes after consumption of the drink. The glucometer readings will determine which group the participants are assigned to. Body mass will be measured by dual-energy x-ray absorptiometry (DEXA). Height will be measured at the first visit and weight at each visit. Venous blood samples will be taken at baseline, then 30, 60, 90, 120, 150 and 180 minutes after consumption of each test meal for measurement of glucose, insulin, C-peptide and triglycerides.
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Primary Outcome(s)
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Insulin sensitivity as assessed by meal tolerance tests. Plasma glucose will be measured using an automated spectrophotometric analyzer and serum insulin will be measured by commercial ELISA kits[Blood samples are taken fasting, and then 30, 60, 90, 120, 150 and 180 minutes after consumption of each test meal.]
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Secondary Outcome(s)
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C-peptide concentrations as assessed by meal tolerance tests. C-peptide will be measured by commercial ELISA kits.[Blood samples are taken fasting, and then 30, 60, 90, 120, 150 and 180 minutes after consumption of each test meal.]
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Triglyceride concentrations as assessed by meal tolerance tests. Triglycerides will be measured using an automated spectrophotometric analyser.[Blood samples are taken fasting, and then 30, 60, 90, 120, 150 and 180 minutes after consumption of each test meal.]
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Source(s) of Monetary Support
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University of South Australia
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Ethics review
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Status: Approved
Approval date:
Contact:
University of South Australia
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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