Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000172909
Ethics application status
Approved
Date submitted
3/02/2020
Date registered
17/02/2020
Date last updated
14/03/2022
Date data sharing statement initially provided
17/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
TuMMI Trial: Temperature treatment of Milk impacts on MRI digestion rates and nutrient delivery
Scientific title
The impact of ultra-high temperature (UHT) treatment of milk compared to pasteurisation on the rate of digestion and nutrient appearance in healthy young women.
Secondary ID [1] 300185 0
None
Universal Trial Number (UTN)
U1111-1244-4996
Trial acronym
TuMMI Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dairy intolerance 316170 0
Digestive disorders 316171 0
Condition category
Condition code
Oral and Gastrointestinal 314019 314019 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 314028 314028 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who habitually consume dairy and are self-described as dairy tolerant will be recruited from the general population. Following informed consent, participants will be randomised to consume on a single morning either 500 mL ultra-high temperature (UHT) bovine milk, or 500 mL pasteurised bovine milk (PAST) within 5 minutes. After a wash- out phase of minimum 3 days, the participants will cross over and receive the other treatment.
Intervention code [1] 316462 0
Treatment: Other
Intervention code [2] 316463 0
Lifestyle
Comparator / control treatment
pasteurised liquid bovine milk, 500 ml (PAST)
Control group
Active

Outcomes
Primary outcome [1] 322425 0
Half gastric emptying time (T1/2) between UHT and PAST bovine milk ingestion as assessed by MRI.,
Timepoint [1] 322425 0
Gastric emptying T1/2 which will be determined from volumes captured at regular intervals after milk ingestion. At 5 minutes after milk ingestion, an MRI will be taken and from 10 minutes, every 10 minutes for half an hour. At 30 minutes after milk ingestion. MRI will be taken every 30 minutes till the T120 mark. Final scan will be conducted at T180.
Secondary outcome [1] 378487 0
To investigate the difference in gastric emptying parameters between UHT and PAST, including TMAX, AUC, and CMAX
Timepoint [1] 378487 0
Mean difference between MRI scans, will be taken every 10 minutes for half an hour. At 30 minutes after milk ingestion. MRI will be taken every 30 minutes till the T120 mark. Final scan will be conducted at T180.
Secondary outcome [2] 378488 0
To investigate the differences in peripheral amino acid appearance changes between UHT and PAST milk after ingestion
Timepoint [2] 378488 0
Mean difference of blood response of peripheral amino acid appearance, as measured by HPLC, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [3] 378490 0
To investigate the differences in peripheral fatty acid appearance changes between UHT and PAST milk after ingestion
Timepoint [3] 378490 0
Mean difference of blood response of peripheral fatty acid appearance, as measured by GC-FID / GC-MS, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [4] 378492 0
To investigate the differences in peripheral lipidome composition changes between UHT and PAST milk after ingestion
Timepoint [4] 378492 0
Mean difference of blood response of peripheral lipidome composition (including triglyceride responses), as measured by LC-MS/MS, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [5] 378493 0
To investigate the differences in peripheral B vitamin and vitamer appearance changes between UHT and PAST milk after ingestion
Timepoint [5] 378493 0
Mean difference of blood response of peripheral B vitamin and vitamer appearance, as measured by UPLC-MS/MS collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [6] 379111 0
To investigate the differences in peripheral fat soluble vitamin changes between UHT and PAST milk after ingestion
Timepoint [6] 379111 0
Mean difference of blood response of peripheral fat soluble vitamin, as measured by LC-MS/MS, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [7] 379112 0
To investigate the differences in peripheral mineral appearance c changes between UHT and PAST milk after ingestion
Timepoint [7] 379112 0
Mean difference of blood response of peripheral mineral appearance, as measured by ICP-MS, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [8] 379113 0
To investigate the differences in exploratory plasma metabolite changes between UHT and PAST milk after ingestion
Timepoint [8] 379113 0
Mean difference of blood response of plasma metabolites, as measured by HILIC / LC-MS/MS / GC-MS / NMR, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [9] 379116 0
To investigate the differences in plasma glycaemic response to ingestion between UHT and PAST
Timepoint [9] 379116 0
Mean difference of blood response of glucose and insulin, as measured by electrochemiluminescent and colorimetric assays, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [10] 379117 0
To investigate the differences in plasma appetite hormone response to ingestion between UHT and PAST
Timepoint [10] 379117 0
Mean difference of blood responses of appetite hormones (including CCK, PYY, GLP-1, and ghrelin), by immunoassays, collected at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [11] 379118 0
To investigate the differences in subjective appetite responses between UHT and PAST.
Timepoint [11] 379118 0
Mean difference in appetite responses and digestive comfort using visual analog scales at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [12] 379119 0
To investigate the differences in subjective digestive responses between UHT and PAST.
Timepoint [12] 379119 0
Mean difference in subjective digestive comfort responses using visual analog scales at 0, 20, 30, 40, 60, 90, 120, 180, 240, and 300 min at each visit
Secondary outcome [13] 379120 0
To investigate the differences in physiological (body surface gastric mapping – BSGM) in response to UHT and PAST ingestion.
Timepoint [13] 379120 0
Mean difference of BSGM activity (as assessed using high resolution electrogastrography by cutaneously applied electrode arrays) continuously (aside from MRI scanning times) at each visit.
Secondary outcome [14] 379121 0
To investigate the differences in physiological (plethysmography; abdominal distension) in response to UHT and PAST ingestion.
Timepoint [14] 379121 0
Mean difference of plethysmography (abdominal distension), as measured by stretch sensors and/or waist circumference, continuously (aside from MRI scanning times) 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.
c) Self-described habitual dairy consumer as assessed by average weekly liquid milk consumption of 3x 250 mL (1 glass). Can be consumed as a drink or as fluid milk in other forms (e.g. milk with tea, coffee, cereal, etc.)
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 or lactose intolerance
• Self-described dairy intolerant based on previous screening tools for lactose intolerance (score >70/500)
• Known significant gastrointestinal disorder (i.e. celiac, IBD, etc.)
• Irritable bowel syndrome and/or gastroesophageal dysfunction, based on the Rome IV criteria
• 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
• Conditions precluding MRI scans, including contraindicated medical devices or implants, body piercings or tattoos, eye injuries involving metal, etc.

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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Double blinded, positive controlled, randomised, cross-over study.
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
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
24/02/2020
Actual
3/03/2020
Date of last participant enrolment
Anticipated
31/03/2021
Actual
11/05/2021
Date of last data collection
Anticipated
30/04/2021
Actual
6/07/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 22204 0
New Zealand
State/province [1] 22204 0
Auckland

Funding & Sponsors
Funding source category [1] 304618 0
Government body
Name [1] 304618 0
New Zealand Ministry of Business Innovation and Employment
Country [1] 304618 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Riddet Institute, Massey University
Private Bag 11 222
Palmerston North 4442, New Zealand
+64 6 356 9099 x84742
Country
New Zealand
Secondary sponsor category [1] 305099 0
University
Name [1] 305099 0
Liggins Institute, University of Auckland
Address [1] 305099 0
85 Park Road,
Grafton, Auckland 1023
New Zealand
Country [1] 305099 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305039 0
Health and Disability Ethics Committees
Ethics committee address [1] 305039 0
Ethics committee country [1] 305039 0
New Zealand
Date submitted for ethics approval [1] 305039 0
27/11/2019
Approval date [1] 305039 0
13/12/2019
Ethics approval number [1] 305039 0
19/CEN/205

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99066 0
Dr Amber Milan
Address 99066 0
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 99066 0
New Zealand
Phone 99066 0
+64 9 923 4785
Fax 99066 0
Email 99066 0
[email protected]
Contact person for public queries
Name 99067 0
Amber Milan
Address 99067 0
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 99067 0
New Zealand
Phone 99067 0
+64 9 923 4785
Fax 99067 0
Email 99067 0
[email protected]
Contact person for scientific queries
Name 99068 0
Richard Mithen
Address 99068 0
Liggins Institute
University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 99068 0
New Zealand
Phone 99068 0
+64 9 923 1336
Fax 99068 0
Email 99068 0
[email protected]

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 ([email protected]). To gain access, requests will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6518Study protocol  [email protected]



Results publications and other study-related documents

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