Trial Review

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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
Date results information initially provided
16/10/2023
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] 308326 0
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 328112 0
Condition category
Condition code
Oral and Gastrointestinal 325169 325169 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 325170 325170 0 0
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] 324774 0
Treatment: Other
Intervention code [2] 324775 0
Lifestyle
Comparator / control treatment
A SOFT dairy gel (150g), produced by acid coagulation at pH 6.5.
Control group
Active

Outcomes
Primary outcome [1] 332988 0
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] 332988 0
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] 415446 0
To investigate the differences in individual and pooled peripheral amino acid appearance changes between FIRM-G and SOFT-G after ingestion.
Timepoint [1] 415446 0
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] 415447 0
To investigate the differences in plasma glycaemic response to ingestion between FIRM-G and SOFT-G
Timepoint [2] 415447 0
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] 415448 0
To investigate the differences in peripheral calcium appearance c changes between FIRM-G and SOFT-G after ingestion
Timepoint [3] 415448 0
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] 415449 0
To investigate the differences in physiological (body surface gastric mapping – BSGM) responses to FIRM-G and SOFT-G ingestion.
Timepoint [4] 415449 0
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] 415450 0
To investigate the differences in subjective appetite responses between FIRM-G and SOFT-G
Timepoint [5] 415450 0
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] 415451 0
To investigate the differences in subjective digestive responses between FIRM-G and SOFT-G
Timepoint [6] 415451 0
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] 415591 0
To investigate the differences in plasma triacylglyceridaemic response to ingestion between FIRM-G and SOFT-G
Timepoint [7] 415591 0
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
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 25100 0
New Zealand
State/province [1] 25100 0

Funding & Sponsors
Funding source category [1] 312569 0
Government body
Name [1] 312569 0
Ministry of Business Innovation and Employment
Country [1] 312569 0
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] 314177 0
University
Name [1] 314177 0
Liggins Institute, University of Auckland
Address [1] 314177 0
85 Park Road,
Grafton, Auckland 1023
Country [1] 314177 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311896 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 311896 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 311896 0
New Zealand
Date submitted for ethics approval [1] 311896 0
12/10/2022
Approval date [1] 311896 0
21/10/2022
Ethics approval number [1] 311896 0
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 122758 0
Dr Amber Milan
Address 122758 0
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 122758 0
New Zealand
Phone 122758 0
+64 9 923 4785
Fax 122758 0
Email 122758 0
a.milan@auckland.ac.nz
Contact person for public queries
Name 122759 0
Dr Amber Milan
Address 122759 0
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 122759 0
New Zealand
Phone 122759 0
+64 9 923 4785
Fax 122759 0
Email 122759 0
a.milan@auckland.ac.nz
Contact person for scientific queries
Name 122760 0
Dr Amber Milan
Address 122760 0
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 122760 0
New Zealand
Phone 122760 0
+64 9 923 4785
Fax 122760 0
Email 122760 0
a.milan@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data (including data dictionaries) collected during the trial will be available after de-identification, along with the study protocol.
When will data be available (start and end dates)?
Data will be available beginning 3 months following the first publication of study results and ending 36 months following publication.
Available to whom?
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.
Available for what types of analyses?
For use to achieve the aims in an approved proposal.
How or where can data be obtained?
Proposals should be directed to the principle investigator (a.milan@auckland.ac.nz). To gain access, requests will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17517Study protocol  a.milan@auckland.ac.nz



Results publications and other study-related documents

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