ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001418763

Ethics application status

Approved

Date submitted

2/11/2022

Date registered

7/11/2022

Date last updated

16/10/2023

Date data sharing statement initially provided

7/11/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

PuDDing trial: Protein-augmented Dairy Dessert nutrient delivery and digestion in females

Scientific title

The impact of firm compared to soft coagulated protein-augmented bovine dairy gel on the appearance of amino acids in peripheral blood in healthy female adults.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1283-2349

Trial acronym

PuDDing Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dairy digestion

Condition category

Condition code

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Diet and Nutrition

Other diet and nutrition disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants who are female and are self-described as non-allergic to milk will be recruited from the general population. Following informed consent, participants will be randomised to consume on a single morning either 150g firm protein-augmented acid coagulated dairy gel (FIRM-G), produced by acid coagulation at pH 5.6, or 150g soft protein-augmented acid coagulated dairy gel (SOFT-G) within 10 minutes. Adherence will be monitored through ingestion under clinical monitoring. After a wash- out phase of minimum 3 days, the participants will cross over and receive the other treatment.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Comparator / control treatment

A SOFT dairy gel (150g), produced by acid coagulation at pH 6.5.

Control group

Active

Outcomes

Primary outcome [1]

To compare the plasma indispensable amino acid concentration area under the curve (AUC0-300 minutes) between FIRM-G and SOFT-G following ingestion in habitual dairy tolerant females following acute ingestion.

Timepoint [1]

Mean difference of blood response of peripheral amino acid appearance, as measured by HPLC, collected at 0, 30, 60, 90, 120, 180, 240, and 300 min after dairy gel ingestion at each visit

Secondary outcome [1]

To investigate the differences in individual and pooled peripheral amino acid appearance changes between FIRM-G and SOFT-G after ingestion.

Timepoint [1]

Mean difference of blood response of peripheral amino acid appearance, as measured by HPLC, collected at 0, 30, 60, 90, 120, 180, 240, and 300 min after dairy gel ingestion at each visit

Secondary outcome [2]

To investigate the differences in plasma glycaemic response to ingestion between FIRM-G and SOFT-G

Timepoint [2]

Mean difference of blood response of glucose and insulin, as measured by electrochemiluminescent and colorimetric assays, collected at 0, 30, 60, 90, 120, 180, 240, and 300 min after dairy gel ingestion at each visit

Secondary outcome [3]

To investigate the differences in peripheral calcium appearance c changes between FIRM-G and SOFT-G after ingestion

Timepoint [3]

Mean difference of blood response of peripheral calcium appearance, as measured by colorimetric assay, collected at 0, 30, 60, 90, 120, 180, 240, and 300 min after dairy gel ingestion at each visit

Secondary outcome [4]

To investigate the differences in physiological (body surface gastric mapping – BSGM) responses to FIRM-G and SOFT-G ingestion.

Timepoint [4]

Mean difference of BSGM activity (as assessed using high resolution electrogastrography by cutaneously applied electrode arrays) continuously for 5 hours after dairy gel ingestion at each visit.

Secondary outcome [5]

To investigate the differences in subjective appetite responses between FIRM-G and SOFT-G

Timepoint [5]

Mean difference in subjective appetite responses using visual analog scales at 0, 30, 60, 90, 120, 180, 240, and 300 min after dairy gel ingestion at each visit

Secondary outcome [6]

To investigate the differences in subjective digestive responses between FIRM-G and SOFT-G

Timepoint [6]

Mean difference in subjective digestive comfort responses using visual analog scales at 0, 30, 60, 90, 120, 180, 240, and 300 min after dairy gel ingestion at each visit

Secondary outcome [7]

To investigate the differences in plasma triacylglyceridaemic response to ingestion between FIRM-G and SOFT-G

Timepoint [7]

Mean difference of blood response of triacylglycerides, as measured by electrochemiluminescent and colorimetric assays, collected at 0, 30, 60, 90, 120, 180, 240, and 300 min after dairy gel ingestion at each visit

Eligibility

Key inclusion criteria

a) Female adult (18-40 years). Female participants will need to declare stage of menstrual cycle during the different study phases, if applicable.

b) A BMI between 18 and 30 kg/m2.

Minimum age

18 Years

Maximum age

40 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

• Inability to give informed consent
• Known bovine milk allergy
• Known significant gastrointestinal disorder (i.e. celiac, IBD, etc.)
• Known chronic disease such as diabetes, cardiovascular, cancer, renal failure, previous gastrointestinal surgery other than cholecystectomy or appendectomy, neurological conditions such as multiple sclerosis, spinal cord injury, or stroke, self-reported alcohol intake exceeding a moderate intake (>28 units per week)
• Current medication use expected to interfere with normal digestive or metabolic processes including proton pump inhibitors, laxatives, antibiotics etc.
• Pregnancy, breastfeeding
• Unwillingness to comply with the study procedures

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 randomised to receive the intervention or the positive control as the first in a crossover sequence using computer generated sequences.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Allocation sequence will be set up as though a web-based secure database. Sequences will be administered by the independent data management team and will not be accessible to the research team prior to allocation.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Pharmacokinetics / pharmacodynamics

Statistical methods / analysis

Interventions will be compared for the primary outcome using Student's paired t-test.

Categorical variables: Chi-squared tests (or Fisher’s Exact tests for small samples). Continuous variables will be applied to (parametric) t-tests or multi-factorial mixed models and (non-parametric) Mann-Whitney tests for symmetrically and asymmetrically distributed data, respectively.

Relationships between biological, subjective, and physiological measures, as well as agreement between clinical measures and pre-clinical/in vitro measures (concurrent separate investigations) by regression, correlation, and multivariate analysis.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

21/11/2022

Actual

13/01/2023

Date of last participant enrolment

Anticipated

31/03/2023

Actual

5/05/2023

Date of last data collection

Anticipated

28/04/2023

Actual

19/06/2023

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Ministry of Business Innovation and Employment

Address [1]

15 Stout Street, Wellington 6011 PO Box 1473, Wellington 6140

Country [1]

New Zealand

Primary sponsor type

University

Name

Massey University

Address

Riddet Institute, Massey University
Private Bag 11 222
Palmerston North 4442

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

Liggins Institute, University of Auckland

Address [1]

85 Park Road, Grafton, Auckland 1023

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committees

Ethics committee address [1]

Health and Disability Ethics Committees 
Ministry of Health 
133 Molesworth Street 
PO Box 5013 
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

12/10/2022

Approval date [1]

21/10/2022

Ethics approval number [1]

2022 EXP 13438

Summary

Brief summary

The structure of ruminant milks is an important factor influencing their health and nutritional properties. Although food processing techniques change the structure of milks, not much is known about how these changes affect digestion, and the resulting health effects. 

This study aims to compare the digestive responses to two structurally different processed dairies with the same composition, to better understand the influence of processing on digestion and nutrient delivery. To do this, acute responses to two dairy desserts that have been created using food-grade acidification under different pH levels to coagulate dairy proteins to different extents, in women. These will be compared in a randomised, cross-over, single blinded active control trial. Physiological measures will be used to non-invasively assess the digestive process, alongside biological responses, tracking nutrient appearance, and subjective measures of digestion. 

Hypothesis:  That differences in the structural assemblies present in firm and soft bovine dairy gels (FIRM-G and SOFT-G) arising from the different food processing methods will result in differences in digestion and nutrient delivery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Amber Milan

Address

Liggins Institute University of Auckland 85 Park Road Grafton Auckland 1023

Country

New Zealand

Phone

+64 9 923 4785

Fax

[email protected]

Contact person for public queries

Name

Amber Milan

Address

Liggins Institute University of Auckland 85 Park Road Grafton Auckland 1023

Country

New Zealand

Phone

+64 9 923 4785

Fax

[email protected]

Contact person for scientific queries

Name

Amber Milan

Address

Liggins Institute University of Auckland 85 Park Road Grafton Auckland 1023

Country

New Zealand

Phone

+64 9 923 4785

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Data will be available to investigators who provide a methodologically sound proposal approved by the study Steering Committee, for use to achieve the aims in the approved proposal. Proposals should be directed to the principle investigator. To gain access, requests will need to sign a data access agreement.

Conditions for requesting access:
• -

What individual participant data might be shared?

• Individual participant data (including data dictionaries) collected during the trial will be available after de-identification, along with the study protocol.

What types of analyses could be done with individual participant data?

• For use to achieve the aims in an approved proposal.

When can requests for individual participant data be made (start and end dates)?

From:
Data will be available beginning 3 months following the first publication of study results and ending 36 months following publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Proposals should be directed to the principle investigator ([email protected]). To gain access, requests will need to sign a data access agreement.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17517	Study protocol			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically