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Trial registered on ANZCTR


Registration number
ACTRN12615001359527
Ethics application status
Approved
Date submitted
21/09/2015
Date registered
15/12/2015
Date last updated
20/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Digestive and nutrient-bioavailability benefits of goat-milk formula
Scientific title
In young adults, does the ingestion of a goat's milk infant formula or hydrolysed cow's milk infant formula, compared to a whole protein cow's milk formula, result in better digestibility and nutrient bioavailability?
Secondary ID [1] 287504 0
Nil
Universal Trial Number (UTN)
U1111-1174-2954
Trial acronym
DiNGo Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired digestion 296263 0
Condition category
Condition code
Diet and Nutrition 296533 296533 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 296606 296606 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Protein quantity matched beverages, consisting of infant formula, to provide 0.23g/kg of body weight protein (total 350-600ml formula) to be consumed only once on three different occasions separated by at least one week washout period between beverages. Beverages will be consumed in full in the presence of the researchers to confirm compliance. Intervention infant formulas:
1. Whole protein goat growing-up milk formula
2. Hydrolysed protein cow growing-up formula
Each formula, including the whole protein cow's milk control formula, contain the following active ingredients within the range listed, per 100ml of prepared formula:
-minerals
--calcium (94-122 mg)
--phosphorus (68-77 mg)
--magnesium (6.7-32 mg)
--iron (1.0-1.3 mg)
--zinc (0.50-0.60 mg)
--iodine (9-14 mcg)
-marine fish oil
-vitamins
--vitamin A (RE) (41-63 mcg)
--vitamin D3 (1.0 mcg)
--vitamin E (TE) (1.4-1.6 mg)
--vitamin C (9 mg)
--thiamine (62-116 mcg)
--riboflavin (120-193 mcg)
--niacin (0.6-0.8 mg)
--folic acid (12-21 mcg)
-probiotic cultures (lactobaccillus and bifidobacterium: 40-45 million cfu)
Intervention code [1] 292892 0
Lifestyle
Intervention code [2] 292893 0
Treatment: Other
Comparator / control treatment
Control infant formula: Whole protein cow growing-up formula
Control group
Active

Outcomes
Primary outcome [1] 296159 0
Differences in plasma amino acid concentrations measured by UPLC after formula ingestion relative to control formula plasma amino acid concentrations
Timepoint [1] 296159 0
Baseline and hourly for 5 hours post-meal at each visit
Primary outcome [2] 296224 0
Differences in amino acid concentrations measured by UPLC in plasma after each formula ingestion relative relative to formula amino acid concentrations
Timepoint [2] 296224 0
Baseline and hourly for 5 hours post-meal at each visit
Secondary outcome [1] 317650 0
Differences in plasma glucose concentrations measured by enzymatic colorimetric assay after formula ingestion relative to control formula
Timepoint [1] 317650 0
Baseline and hourly for 5 hours post-meal at each visit
Secondary outcome [2] 317651 0
Differences in chylomicron TAG composition measured by lipidomic analysis (GC-FID) after formula ingestion relative to control formula
Timepoint [2] 317651 0
Baseline and hourly for 5 hours post-meal at each visit
Secondary outcome [3] 317652 0
Differences in plasma mineral concentrations measured by ICP-MS after formula ingestion relative to control formula
Timepoint [3] 317652 0
Baseline and hourly for 5 hours post-meal at each visit
Secondary outcome [4] 317653 0
Differences in plasma vitamin concentrations as measured by HPLC, ID-LC-MS/MS, and LC-MS after formula ingestion relative to control formula
Timepoint [4] 317653 0
Baseline and hourly for 5 hours post-meal at each visit
Secondary outcome [5] 317654 0
Differences in gastric emptying measured by recovered plasma paracetamol by enzymatic colorimetric assay after formula ingestion relative to control formula
Timepoint [5] 317654 0
Baseline and every 15 minute for 90 minutes, every 30 minutes until 2 hours, and hourly until 5 hours post-meal at each visit
Secondary outcome [6] 317655 0
Differences in appetite scores as measured by a visual analog scale before and following formula ingestion relative to control formula
Timepoint [6] 317655 0
Appetite measures taken once upon arrival, and once immediately prior to drink ingestion (two baseline assessments to account for individual variation), immediately following ingestion, and then at 15 min intervals for the first 90 minutes, then hourly starting at 2 hours for 5 hours. Taken at each visit.
Secondary outcome [7] 317868 0
Differences in plasma insulin concentrations measured by radio-immunoassay array after formula ingestion relative to control formula
Timepoint [7] 317868 0
Baseline and hourly for 5 hours post-meal at each visit
Secondary outcome [8] 317869 0
Differences in plasma appetite hormone concentrations measured by flow cytometric multiplex array after formula ingestion relative to control formula
Timepoint [8] 317869 0
Baseline and hourly for 5 hours post-meal at each visit
Secondary outcome [9] 317870 0
Differences in liking scores as measured by a visual analog scale following formula ingestion relative to control formula
Timepoint [9] 317870 0
Hedonic liking scores will be completed immediately following drink ingestion, and prior to paracetamol ingestion. Taken at each visit.
Secondary outcome [10] 319550 0
Differences in carbohydrate malabsorption measured by breath hydrogen concentrations after formula ingestion relative to control formula
Timepoint [10] 319550 0
Baseline and hourly for 3 hours post-meal at each visit

Eligibility
Key inclusion criteria
18 - 28 years old
BMI 18-25kg/m2
Healthy (no current or past history of gastric reflux, irritable bowel syndrome, Crohn's disease, anosmia, diabetes, heart disease, hypertension, hyper(dys)lipidemia)
Dairy, lactose, and paracetamol tolerant
Minimum age
18 Years
Maximum age
28 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy or intolerance to dairy, lactose, or paracetamol
Current or past history of gastric reflux, irritable bowel syndrome, Crohn's disease, anosmia, diabetes, cardiovascular disease (myocardial infarction, angina, stroke), hypertension, hyper(dys)lipidemia
Self reported alcohol intake exceeding a moderate intake (>28 unites/week)
Abnormal liver function or haematology

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 newspapers. Telephone screening will firstly identify participants within the required age ranges and exclude those likely to be experiencing exclusion factors (family history of diabetes and heart disease). 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 Participant Information Sheet has been read and understood. Participants meeting the inclusion requirement will be invited to undertake the study and a date provided for the first beverage consumption. Allocation will be concealed by use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7176 0
New Zealand
State/province [1] 7176 0

Funding & Sponsors
Funding source category [1] 292080 0
Commercial sector/Industry
Name [1] 292080 0
AgResearch Ltd.
Address [1] 292080 0
5th Floor, Tower Block
Ruakura Research Centre
Bisley Road
Private Bag 3115
Hamilton 3240
Country [1] 292080 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AgResearch Ltd.
Address
5th Floor, Tower Block
Ruakura Research Centre
Bisley Road
Private Bag 3115
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 290756 0
Commercial sector/Industry
Name [1] 290756 0
Auckland UniServices Ltd.
Address [1] 290756 0
Level 10, UniServices House,
70 Symonds Street, Auckland
Private Bag 92019, Victoria Street West,
Auckland 1142, New Zealand
Country [1] 290756 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293562 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 293562 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293562 0
New Zealand
Date submitted for ethics approval [1] 293562 0
16/09/2015
Approval date [1] 293562 0
27/11/2015
Ethics approval number [1] 293562 0
15/STH/167

Summary
Brief summary
Goat’s milk is increasingly used as an alternative to cow’s milk for infant formula. This study aims to determine how goat’s milk digestion differs from cow’s milk digestion, and in particular look at the digestibility of proteins, fats, vitamins and minerals in goat or cow’s milk infant formula preparations. The study will use infant formula designed for infants after 12 months of age, who consume a mixed diet including solid foods, making a comparison of digestive capacity comparable to young adults, allowing for an intervention in young adults rather than in infants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60470 0
Prof David Cameron-Smith
Address 60470 0
Liggins Institute
University of Auckland
2-6 Park Avenue
Grafton, Auckland
Private Bag 92019
Auckland 1142
Country 60470 0
New Zealand
Phone 60470 0
+6499231336
Fax 60470 0
Email 60470 0
d.cameron-smith@auckland.ac.nz
Contact person for public queries
Name 60471 0
Prof David Cameron-Smith
Address 60471 0
Liggins Institute
University of Auckland
2-6 Park Avenue
Grafton, Auckland
Private Bag 92019
Auckland 1142
Country 60471 0
New Zealand
Phone 60471 0
+6499231336
Fax 60471 0
Email 60471 0
d.cameron-smith@auckland.ac.nz
Contact person for scientific queries
Name 60472 0
Prof David Cameron-Smith
Address 60472 0
Liggins Institute
University of Auckland
2-6 Park Avenue
Grafton, Auckland
Private Bag 92019
Auckland 1142
Country 60472 0
New Zealand
Phone 60472 0
+6499231336
Fax 60472 0
Email 60472 0
d.cameron-smith@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary