Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001030268
Ethics application status
Approved
Date submitted
15/06/2018
Date registered
19/06/2018
Date last updated
11/03/2019
Date data sharing statement initially provided
11/03/2019
Date results information initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sheep milk nutrient bioavailability and digestive comfort in females who avoid dairy
Scientific title
In young female habitual dairy avoiders, does the ingestion of sheep milk compared to cow milk, result in better digestibility and nutrient bioavailability?
Secondary ID [1] 295176 0
Nil
Universal Trial Number (UTN)
U1111-1209-7768
Trial acronym
ShinDig Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired Digestion 308302 0
Digestive discomfort 308303 0
Malabsorption 308387 0
Condition category
Condition code
Diet and Nutrition 307307 307307 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 307326 307326 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volume matched whole milk (650ml), to be consumed only once on two different occasions separated by at least one week washout period between beverages. Beverages will be consumed within 15 minutes in full in the presence of the researchers to confirm compliance. Milk will be consumed after a overnight fast (8 hours, water allowed), with no other food or beverage consumed for the duration 4 hour intervention. Milks::
1. Whole sheep milk
2. Whole cow milk
Intervention code [1] 301514 0
Lifestyle
Intervention code [2] 301530 0
Treatment: Other
Comparator / control treatment
Whole cow milk
Control group
Active

Outcomes
Primary outcome [1] 306278 0
The difference in peak branched-chain amino acid concentration in plasma measured by UPLC between two interventions
Timepoint [1] 306278 0
At 60 minutes post milk ingestion at each visit.
Secondary outcome [1] 348062 0
Mean differences in postprandial plasma amino acid measured by UPLC between two interventions
Timepoint [1] 348062 0
Change from fasting and every 60 minutes for 4 hours post milk ingestion compared between the two interventions.
Secondary outcome [2] 348063 0
Mean differences in plasma lipidomic profile measured using GC-FID.
Timepoint [2] 348063 0
Change from fasting and every 60 minutes for 4 hours post milk ingestion at each visit.
Secondary outcome [3] 348064 0
Mean differences in plasma lipid response (plasma triglycerides, cholesterol, LDL, HDL) measured using enzymatic colorimetric assays,
Timepoint [3] 348064 0
Change from fasting and every 60 minutes for 4 hours post milk ingestion at each visit.
Secondary outcome [4] 348065 0
Mean differences in breath hydrogen excretion measured by a breath H2 analyser between the two interventions.
Timepoint [4] 348065 0
Change from fasting and every 60 minutes for 4 hours post milk ingestion at each visit.
Secondary outcome [5] 348066 0
Mean differences in plasma glucose concentrations measured by enzymatic colorimetric assay between the two interventions.
Timepoint [5] 348066 0
Change from fasting and every 15 minutes for 90 minutes, then hourly from 120 minutes post milk ingestion for 4 hours at each visit.
Secondary outcome [6] 348067 0
Mean differences in subjective appetite responses measured by visual analog scale between the two interventions.
Timepoint [6] 348067 0
Change from fasting and every 30 minutes for 90 minutes then hourly from 120 minutes post milk ingestion for 4 hours at each visit.
Secondary outcome [7] 348069 0
Mean differences in subjective digestive responses measured by visual analog scale between the two interventions.
Timepoint [7] 348069 0
Change from fasting and every 30 minutes for 90 minutes then hourly from 120 minutes post milk ingestion for 4 hours at each visit.
Secondary outcome [8] 348070 0
Mean differences in subjective liking will be measured by using visual analog scale between the two interventions.
Timepoint [8] 348070 0
Immediately post milk ingestion at each visit.
Secondary outcome [9] 348081 0
Mean differences in serum minerals measured by ICP-MS (Ca, Mg, Na, K, Fe, Cu, Zn, Rb, Se, Sr, Sb, Li, Cs, Ba, Cr, Al, Ni, Pb, Co, Cd, As, Nd, Y, Mo, Ce, B, I) between the two interventions.
Timepoint [9] 348081 0
Change from fasting and every 60 minutes for 4 hours post milk ingestion at each visit.
Secondary outcome [10] 348082 0
Mean differences in plasma vitamins measured by LC-MS/MS (B1, B2, B3, B5, B6, B9, B12, H and related vitamer intermediates, vitamin A, D, K) between the two interventions.
Timepoint [10] 348082 0
Change from fasting and every 60 minutes for 4 hours post milk ingestion at each visit.
Secondary outcome [11] 348083 0
Mean differences in exploratory plasma metabolites measured by LC-MS and Nuclear Magnetic Resonance spectroscopy between the two interventions.
Timepoint [11] 348083 0
Change from fasting and every 60 minutes for 4 hours post milk ingestion at each visit.
Secondary outcome [12] 348084 0
Mean differences in exploratory plasma peptide measured by LC-MS and/or Nuclear Magnetic Resonance spectroscopy between the two interventions.
Timepoint [12] 348084 0
Change from fasting and every 60 minutes for 4 hours post milk ingestion at each visit.
Secondary outcome [13] 348085 0
Prevalence of lactase non-persistence genotype measured by genotyping of whole blood
Timepoint [13] 348085 0
Fasting samples at the baseline visit.
Secondary outcome [14] 348261 0
Mean differences in plasma insulin concentrations measured by electrochemiluminescence immunoassay assay between the two interventions.
Timepoint [14] 348261 0
Change from fasting and every 15 minutes for 90 minutes, then hourly from 120 minutes post milk ingestion for 4 hours at each visit.

Eligibility
Key inclusion criteria
Female
20-40 years
BMI 18-28 kg/m2
Self-described dairy intolerant
No history of gastrointestinal disease or metabolic disease
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Have an allergy to milk.
Are diagnosed with gastrointestinal disease (i.e. celiac, Crohn’s, colitis, etc.) or pre-existing metabolic disease.
Are currently taking medications expected to interfere with normal digestive or metabolic processes including proton pump inhibitors, laxatives, antibiotics (within last 3 months), prebiotics etc.
Have a medical history precluding a healthy state: history of myocardial infarction, angina, stroke, cancer or pre-existing diabetes, self-reported alcohol intake exceeding a moderate intake (>28 units per week).

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)
Allocation to the intervention sequence will be concealed through the use of sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequences will be computer-generated.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Study outcomes will be analysed on a per protocol basis. Primary outcomes will be analysed using repeated factor generalised linear regression adjusted for multiple comparisons. Secondary outcomes will be analysed with repression models appropriate for their distributions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/07/2018
Actual
10/07/2018
Date of last participant enrolment
Anticipated
Actual
6/11/2018
Date of last data collection
Anticipated
Actual
14/11/2018
Sample size
Target
30
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 10558 0
New Zealand
State/province [1] 10558 0
Auckland

Funding & Sponsors
Funding source category [1] 299763 0
Commercial sector/Industry
Name [1] 299763 0
AgResearch Ltd.
Country [1] 299763 0
New Zealand
Funding source category [2] 299775 0
Commercial sector/Industry
Name [2] 299775 0
Blue River Dairy
Country [2] 299775 0
New Zealand
Funding source category [3] 299776 0
Commercial sector/Industry
Name [3] 299776 0
Spring Sheep Milk Co
Country [3] 299776 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
Level 10, Building 620
49 Symonds Street
Aucklnad 1010
Country
New Zealand
Secondary sponsor category [1] 299103 0
Commercial sector/Industry
Name [1] 299103 0
AgResearch Ltd.
Address [1] 299103 0
Grasslands Research Centre
Tennet Drive
Palmerston North 4442
Country [1] 299103 0
New Zealand
Secondary sponsor category [2] 299120 0
Commercial sector/Industry
Name [2] 299120 0
Blue River Dairy
Address [2] 299120 0
PO Box 1547
111 Nith Street
Invercargill 9812
Country [2] 299120 0
New Zealand
Secondary sponsor category [3] 299122 0
Commercial sector/Industry
Name [3] 299122 0
Spring Sheep Milk Co
Address [3] 299122 0
PO Box 91129
Victoria Street West
Auckland 1142
Country [3] 299122 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300654 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 300654 0
Ministry of Health
Ethics Department
133 Molesworth Street
Wellington 6011
New Zealand
Ethics committee country [1] 300654 0
New Zealand
Date submitted for ethics approval [1] 300654 0
22/05/2018
Approval date [1] 300654 0
20/06/2018
Ethics approval number [1] 300654 0
18/NTB/92

Summary
Brief summary
Many people report digestive problems with dairy products. This may be due to the sugar in milk, lactose, which causes intolerance in many people. However, the proteins and fats in milk also affect how it is digested, and how well people can tolerate dairy products. Sheep milk has different protein, fat, and micronutrient content than cow milk, and behaves differently during food processing. The different proteins and fats in sheep milk may be easier to tolerate for some people. For example the A1 version beta-casein is thought to cause digestive discomfort; this is found in typical cow milk but not sheep milk. Similarly, the medium chain fatty acids rich in sheep milk are easily digested and absorbed. Although these differences mean that sheep milk is likely to be digested differently, so far this hasn’t yet been studied.
Women will be recruited who self-report digestive issues with cow milk and will be provided, in a double blind manner, cow and sheep milk on separate occasions. The digestive response, tolerance to lactose, and appearance of digested products in the blood will be measured to assess the characteristics of digestion and metabolism between sheep and cow milk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84354 0
Prof David Cameron-Smith
Address 84354 0
The Liggins Institute
University of Auckland
Building 505
Grafton, Auckland 1023
Country 84354 0
New Zealand
Phone 84354 0
+6499231336
Fax 84354 0
+649 3738763
Email 84354 0
d.cameron-smith@auckland.ac.nz
Contact person for public queries
Name 84355 0
Prof David Cameron-Smith
Address 84355 0
The Liggins Institute
University of Auckland
Building 505
Grafton, Auckland 1023
Country 84355 0
New Zealand
Phone 84355 0
+6499231336
Fax 84355 0
+649 3738763
Email 84355 0
d.cameron-smith@auckland.ac.nz
Contact person for scientific queries
Name 84356 0
Prof David Cameron-Smith
Address 84356 0
The Liggins Institute
University of Auckland
Building 505
Grafton, Auckland 1023
Country 84356 0
New Zealand
Phone 84356 0
+6499231336
Fax 84356 0
+649 3738763
Email 84356 0
d..cameron-smith@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD were not consented to be shared


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
No additional documents have been identified.