HealthyNCT03038854
Growing Up Milk (GUM) Intake and Nutrient Status of Toddlers
A study testing Test GUM, Standard GUM and Cows' milk in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial summary
The purpose of this study is to determine the nutritional and cognitive effects of consuming Growing Up Milks (GUMs) and cow's milk. Read more about this study
- Who is it for?
- Ages 17 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test GUM, Standard GUM and Cows' milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2017to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
- Age 17 - 18 months at enrolment.
- Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg
- Toddler's parent(s)/guardian is of legal age of consent, has sufficient command of English language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol
- Toddler's parent(s)/guardian can be contacted directly by telephone or email throughout the study
Who cannot join
- Toddlers who exhibit one or more of the following criteria are excluded from enrollment in the study:
- Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures
- Known or suspected cows' milk protein intolerance / allergy or severe food allergies that impact diet
- Toddlers fed vegan, vegetarian, or vegetarian plus fish diets
- Cognitive or developmental disorders
- Breast milk used exclusively in place of all other milk, and/or milk alternatives at 17-18 months (GUM \& cows' milk group exclusion only, eligible for population group)
- Consuming supplement(s) of relevance to the study outcome relating diet to status, docosahexaenoic acid (DHA), lutein, and/or choline in amounts >%10 requirements
- Toddlers or toddlers' family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Children and Women's Health Centre of British Columbia Branch
Vancouver
About this study
Official title: Effects of Milk Intake on Nutrient Status and Neurocognitive Development in Toddlers: a Partially Randomized and Controlled Trial
The purpose of this study is to determine the nutritional and cognitive effects of consuming Growing Up Milks (GUMs) and cow's milk.
Read the detailed description
Single-site, double blind, partially randomized, controlled, 4-arm parallel group clinical trial. The purpose of this study is to determine if consuming nutrient enriched growing up milk improves the nutrition status and cognitive performance in healthy toddlers.
- Conditions
- Healthy
- Being tested
- Test GUM, Standard GUM, Cows' milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test GUMOther
Also called Growing up milk
Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.
Standard GUMOther
Also called Growing up milk
Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.
Cows' milkOther
Homogenized store-bought full fat cow's milk.
| Study group | Role | What they receive |
|---|---|---|
| Test GUM | Experimental | This group will drink a test toddler growing up milk (GUM) with higher amounts of key nutrients Receives: Other: Test GUM |
| Standard GUM | Active comparator | This group will drink a standard toddler growing up milk (GUM) Receives: Other: Standard GUM |
| Comparator Group | Placebo comparator | This group will drink liquid full fat cows' milk Receives: Other: Cows' milk |
| Population Group | No intervention | This group will eat and drink their usual foods with no interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of blood nutrient markers after 6 months of intervention
To compare blood status of the key nutrients of interest after 180 days of intervention in toddlers randomized in a double-blind manner to Test GUM compared to standard GUM. A non-randomized group for comparison will drink either cows' milk (comparator group) as currently recommended by Health Canada, or participate in a reference group with no drinking or feeding interventions.
Measured: 6 months
Secondary outcomes (4)
Executive function and language development
To assess the effect of milk/drink on measures of neurological development. Standard and validated tools will be used in the assessment including Bayley Scales of Infant Development III
Measured: 6 months
Visual acuity with Teller Acuity Cards
To characterize the effects of milk/drink on visual acuity
Measured: 6 months
Behavioural development
To characterize the effects of milk/drink on behavioural development using standard questionnaires including the Child Behaviour Checklist (CBCL)
Measured: 6 months
Dietary nutrient intake
To characterize effects of milk/drink on dietary intake of energy, macronutrients and key nutrients of interest using the Food Frequency Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start8 Feb 2017
- Primary completion11 Jul 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Yvonne Lamers, PhD, Principal investigator, University of British ColumbiaTim Oberlander, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038854
- Sponsor's protocol ID
- 14.16.INF
- Status last verified
- Nov 2022
- First submitted
- 25 Jan 2017
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Milk Intake on Nutrient Status and Neurocognitive Development in Toddlers: a Partially Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT03038854
- Acronym / sponsor ID
- 14.16.INF
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- University of British Columbia
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the nutritional and cognitive effects of consuming Growing Up Milks (GUMs) and cow's milk.
Detailed description
Single-site, double blind, partially randomized, controlled, 4-arm parallel group clinical trial. The purpose of this study is to determine if consuming nutrient enriched growing up milk improves the nutrition status and cognitive performance in healthy toddlers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test GUM | Experimental | Other: Test GUMThis group will drink a test toddler growing up milk (GUM) with higher amounts of key nutrients |
| Standard GUM | Active comparator | Other: Standard GUMThis group will drink a standard toddler growing up milk (GUM) |
| Comparator Group | Placebo comparator | Other: Cows' milkThis group will drink liquid full fat cows' milk |
| Population Group | No intervention | –This group will eat and drink their usual foods with no interventions. |
Who may qualify
- Ages
- 17 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
- Age 17 - 18 months at enrolment.
- Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg
- Toddler's parent(s)/guardian is of legal age of consent, has sufficient command of English language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol
- Toddler's parent(s)/guardian can be contacted directly by telephone or email throughout the study
Key exclusion criteria (8 listed)
- Toddlers who exhibit one or more of the following criteria are excluded from enrollment in the study:
- Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures
- Known or suspected cows' milk protein intolerance / allergy or severe food allergies that impact diet
- Toddlers fed vegan, vegetarian, or vegetarian plus fish diets
- Cognitive or developmental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test GUMAlso: Growing up milkGrowing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children. | Other | Test GUM |
| Standard GUMAlso: Growing up milkGrowing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children. | Other | Standard GUM |
| Cows' milkHomogenized store-bought full fat cow's milk. | Other | Comparator Group |
Primary outcome
Comparison of blood nutrient markers after 6 months of intervention
Time frame: 6 months
To compare blood status of the key nutrients of interest after 180 days of intervention in toddlers randomized in a double-blind manner to Test GUM compared to standard GUM. A non-randomized group for comparison will drink either cows' milk (comparator group) as currently recommended by Health Canada, or participate in a reference group with no drinking or feeding interventions.
4 secondary outcomes
Executive function and language development
Time frame: 6 months
Visual acuity with Teller Acuity Cards
Time frame: 6 months
Behavioural development
Time frame: 6 months
Dietary nutrient intake
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Lamers, PhD principal investigator
University of British Columbia
Tim Oberlander, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test GUM, Standard GUM and Cows' milk in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of blood nutrient markers after 6 months of intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.