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Trial registered on ANZCTR
Registration number
ACTRN12615001108505
Ethics application status
Approved
Date submitted
9/06/2015
Date registered
21/10/2015
Date last updated
6/10/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of a high protein high glycaemic index meal on metabolic health markers in post-menopausal women aged between 55-70 years old.
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Scientific title
The effect of high protein high glycaemic index meal on metabolic health markers in post-menopausal women age between 55-70 years old.
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Secondary ID [1]
286875
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Nil
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Universal Trial Number (UTN)
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Trial acronym
HiProM: High Protein Meals
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome
295277
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Condition category
Condition code
Metabolic and Endocrine
295526
295526
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0
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Diabetes
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Metabolic and Endocrine
295614
295614
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0
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Iso-energetic meals of high protein with high glycaemic index carbohydrates or high protein with low glycaemic index carbohydrates. The meal will be consumed for breakfast after an overnight fast (7pm-7am) and followed by a one week wash out period between study meals. The meals will consist of 30% protein, 20% fats and 50% carbohydrates. The glycaemic index of the low glycemic meal will be approximately 30 and the High glycaemic meal will be approximately 75. The two meals have an energy content of 590 kcal or 2470kJ.
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Intervention code [1]
292053
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Lifestyle
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Intervention code [2]
292112
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Treatment: Other
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Comparator / control treatment
A single meal of high protein low glycaemic index will be used as the control meal
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Control group
Active
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Outcomes
Primary outcome [1]
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Identification of metabolites through the use of mass spectrometry seperation and detection to chemically characterise in breath and blood. There is no metabolites being specifically analysed as this an discovery study. The aim is to see a difference between healthy and Metabolic Syndrome women.
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Assessment method [1]
295265
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Timepoint [1]
295265
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Blood samples will be taken at baseline and every 30 minutes for 5 hours post meal at each visit.
Breath samples will be collected by expiring gas for 20 minutes at baseline, 2 hours post meal consumption and 4 hours post meal consumption.
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Secondary outcome [1]
315209
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Hormone status including sex steroids (estrogen, testosterone, cortisol), metabolic hormones (insulin) and bone markers (C-telopeptide of type I collagen (CTX-1), vitamin D, Parathyroid hormone) will be measure to accurately profile metabolic health and response to meals. This a composite secondary outcome as each outcome will be brought together to give a full metabolic profile.
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Assessment method [1]
315209
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Timepoint [1]
315209
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Blood samples will be taken at baseline and every 30 minutes for 5 hours post meal at each visit.
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Eligibility
Key inclusion criteria
Female, postmenopausal, BMI 18-34
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Minimum age
55
Years
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Maximum age
70
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
BMI outside of the range 18-34. History of cancer or heart disease or exisiting diagnosis of diabetes
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited by public notices and advertisements placed in community newpapers. Telephone screening will first identify participants within the required ranges and exclude those likely to be experiencing factors (family history of heart disease and cancer). Participants meeting this screening will be forwarded the Participant Information sheet and consent form. The participants will be invited to a face to face meeting with the researchers to ensure the Participants information sheet has been read and understood. At this meeting, participants will undergo a DEXA to verify inclusion criteria (BMI 18-34). Participants meeting the inclusion requirements will be invited to undertake the study and a date provided for the first breakfast meal. Allocation will be concealed by the use of sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e computerised sequence generation).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/09/2015
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Date of last participant enrolment
Anticipated
20/11/2015
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Actual
20/11/2015
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Date of last data collection
Anticipated
22/12/2017
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Actual
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment outside Australia
Country [1]
6963
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New Zealand
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State/province [1]
6963
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Funding & Sponsors
Funding source category [1]
291687
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Commercial sector/Industry
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Name [1]
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Auckland Uniservices Ltd
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Address [1]
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Auckland Uniservices Ltd
70 Symonds Street
Auckland 1142
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Country [1]
291687
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New Zealand
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Primary sponsor type
Commercial sector/Industry
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Name
Auckland Uniservices
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Address
Auckland Uniservices Ltd
70 Symonds Street
Auckland 1142
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Country
New Zealand
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Secondary sponsor category [1]
290111
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None
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Name [1]
290111
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Address [1]
290111
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Country [1]
290111
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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UAHPEC- University of Auckland Human Participants Ethics committee
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Ethics committee address [1]
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Level 10, 49 Symonds Street, Auckland, 1010
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Ethics committee country [1]
292985
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New Zealand
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Date submitted for ethics approval [1]
292985
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Approval date [1]
292985
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06/06/2015
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Ethics approval number [1]
292985
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Summary
Brief summary
Diabetes and cardiovascular diseases remain the major cause of preventable ill health and premature death in developed nations. This burden is shared across both genders, although there is far less known in women than men. Following menopause, women experience a rapid increase in metabolic health risk, yet predictive detection is lacking. Diabetes and cardiovascular (heart) diseases have a metabolic basis, in that metabolic processes are altered. Current research suggests that these metabolic alterations are not present under fasting conditions, but may become evident in response to a stimuli (or challenge). In this study we aim to recruit women and following a meal either rich in rapidly digested (high glycaemic) or slowly digested (low glycaemic) carbohydrates take blood samples. These blood samples will be analysed for metabolites (or chemical signatures) that identify metabolic pathway differences. This research can provide new insights into detecting early risks or metabolic abnormalities that place some women at increased risk of ill-health.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof David Cameron-Smith
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Address
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Liggins Institute University of Auckland 2-6 Park Avenue, Grafton, Auckland Private bag 92019, Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 923 1336
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Brenan Durainayagam
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Address
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Liggins Institute University of Auckland 2-6 Park Avenue, Grafton, Auckland Private bag 92019, Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 923 1336
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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David Cameron-Smith
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Address
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Liggins Institute University of Auckland 2-6 Park Avenue, Grafton, Auckland Private bag 92019, Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 923 1336
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Fax
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Circulatory miRNA biomarkers of metabolic syndrome.
2020
https://dx.doi.org/10.1007/s00592-019-01406-6
Embase
Inflexibility of the plasma miRNA response following a high-carbohydrate meal in overweight insulin-resistant women.
2020
https://dx.doi.org/10.1186/s12263-020-0660-8
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Plasma metabolomic response to high-carbohydrate meals of differing glycaemic load in overweight women.
2023
https://dx.doi.org/10.1007/s00394-023-03151-7
N.B. These documents automatically identified may not have been verified by the study sponsor.
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