ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

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

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Metabolic and Endocrine

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]

Lifestyle

Intervention code [2]

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]

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]

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]

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]

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

Sex

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

1/09/2015

Date of last participant enrolment

Anticipated

20/11/2015

Actual

20/11/2015

Date of last data collection

Anticipated

22/12/2017

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Auckland Uniservices Ltd

Address [1]

Auckland Uniservices Ltd
70 Symonds Street
Auckland 1142

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UAHPEC- University of Auckland Human Participants Ethics committee

Ethics committee address [1]

Level 10, 49 Symonds Street, Auckland, 1010

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

06/06/2015

Ethics approval number [1]

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

Prof David Cameron-Smith

Address

Liggins Institute University of Auckland 2-6 Park Avenue, Grafton, Auckland Private bag 92019, Auckland 1142

Country

New Zealand

Phone

+64 9 923 1336

Fax

d.cameron-smith@auckland.ac.nz

Contact person for public queries

Name

Brenan Durainayagam

Address

Liggins Institute University of Auckland 2-6 Park Avenue, Grafton, Auckland Private bag 92019, Auckland 1142

Country

New Zealand

Phone

+64 9 923 1336

Fax

b.durainayagam@auckland.ac.nz

Contact person for scientific queries

Name

David Cameron-Smith

Address

Liggins Institute University of Auckland 2-6 Park Avenue, Grafton, Auckland Private bag 92019, Auckland 1142

Country

New Zealand

Phone

+64 9 923 1336

Fax

d.cameron-smith@auckland.ac.nz

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
Embase	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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically