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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.
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.
Secondary ID [1] 286875 0
Nil
Universal Trial Number (UTN)
Trial acronym
HiProM: High Protein Meals
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 295277 0
Condition category
Condition code
Metabolic and Endocrine 295526 295526 0 0
Diabetes
Metabolic and Endocrine 295614 295614 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 292053 0
Lifestyle
Intervention code [2] 292112 0
Treatment: Other
Comparator / control treatment
A single meal of high protein low glycaemic index will be used as the control meal
Control group
Active

Outcomes
Primary outcome [1] 295265 0
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.
Timepoint [1] 295265 0
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.
Secondary outcome [1] 315209 0
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.
Timepoint [1] 315209 0
Blood samples will be taken at baseline and every 30 minutes for 5 hours post meal at each visit.

Eligibility
Key inclusion criteria
Female, postmenopausal, BMI 18-34
Minimum age
55 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
BMI outside of the range 18-34. History of cancer or heart disease or exisiting diagnosis of diabetes

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)
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.
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).
Masking / blinding
Open (masking not 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
Active, not recruiting
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] 6963 0
New Zealand
State/province [1] 6963 0

Funding & Sponsors
Funding source category [1] 291687 0
Commercial sector/Industry
Name [1] 291687 0
Auckland Uniservices Ltd
Address [1] 291687 0
Auckland Uniservices Ltd
70 Symonds Street
Auckland 1142
Country [1] 291687 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Auckland Uniservices
Address
Auckland Uniservices Ltd
70 Symonds Street
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 290111 0
None
Name [1] 290111 0
Address [1] 290111 0
Country [1] 290111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292985 0
UAHPEC- University of Auckland Human Participants Ethics committee
Ethics committee address [1] 292985 0
Level 10, 49 Symonds Street, Auckland, 1010
Ethics committee country [1] 292985 0
New Zealand
Date submitted for ethics approval [1] 292985 0
Approval date [1] 292985 0
06/06/2015
Ethics approval number [1] 292985 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57914 0
Prof David Cameron-Smith
Address 57914 0
Liggins Institute University of Auckland 2-6 Park Avenue, Grafton, Auckland Private bag 92019, Auckland 1142
Country 57914 0
New Zealand
Phone 57914 0
+64 9 923 1336
Fax 57914 0
Email 57914 0
d.cameron-smith@auckland.ac.nz
Contact person for public queries
Name 57915 0
Mr Brenan Durainayagam
Address 57915 0
Liggins Institute University of Auckland 2-6 Park Avenue, Grafton, Auckland Private bag 92019, Auckland 1142
Country 57915 0
New Zealand
Phone 57915 0
+64 9 923 1336
Fax 57915 0
Email 57915 0
b.durainayagam@auckland.ac.nz
Contact person for scientific queries
Name 57916 0
Prof David Cameron-Smith
Address 57916 0
Liggins Institute University of Auckland 2-6 Park Avenue, Grafton, Auckland Private bag 92019, Auckland 1142
Country 57916 0
New Zealand
Phone 57916 0
+64 9 923 1336
Fax 57916 0
Email 57916 0
d.cameron-smith@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