InfantNCT02441296
Carbohydrate and Metabolism: a Pilot Study
A study testing Formula with lactose and Formula with maltodextrins in people with Infant and Metabolism, run by Umeå University.
Trial summary
The optimal choice of carbohydrate in infant formula needs to be assessed in more detail. Lactose has conventionally been used in most milk-based infant formulas, but more recently lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity. Read more about this study
- Who is it for?
- Ages 3 to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant, Metabolism
- What is being tested?
- Formula with lactose and Formula with maltodextrins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Mar 2016
- 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 3 to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy
- Term infants (gestational age 37-42 weeks)
- Birth weight 2500-4500g
Who cannot join
- Infant illness
- Maternal diabetes
- Maternal pregnancy complications
About this study
Official title: Postprandial Serum Responses to Various Infant Formulas and Breast Milk in Infants- a Pilot Study
The optimal choice of carbohydrate in infant formula needs to be assessed in more detail. Lactose has conventionally been used in most milk-based infant formulas, but more recently lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity. However, the metabolic consequences have not been examined.
In a pilot study, the investigators will assess the postprandial metabolic response to a meal of formula with either lactose or maltodextrins. A breastfed reference group is also included.
- Conditions
- Infant, Metabolism
- Being tested
- Formula with lactose, Formula with maltodextrins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula with lactoseOther
Formula with maltodextrinsOther
| Study group | Role | What they receive |
|---|---|---|
| Formula with lactose | Experimental | Carbohydrate-free formula with added lactose Receives: Other: Formula with lactose |
| Formula with maltodextrins | Experimental | Carbohydrate-free formula with added maltodextrins Receives: Other: Formula with maltodextrins |
| Breastfeeding | No intervention | Breastfed reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels
The change in serum glucose levels are monitored following a test meal from baseline to 15 min, 30 min, 60 min, 90 min and 120 minutes
Measured: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Secondary outcomes (2)
Insulin levels
The change in plasma insulin levels are monitored following a test meal at baseline, 15 min, 30 min, 60 min, 90 min and 120 minutes
Measured: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Metabolite levels
The change in plasma metabolite levels are monitored (using metabolomics) following a test meal at baseline, 15 min, 30 min, 60 min, 90 min and 120 minutes
Measured: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startOct 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfantStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Mead Johnson Nutrition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441296
- Sponsor's protocol ID
- 2013-152-31M
- Status last verified
- Nov 2020
- First submitted
- 8 Apr 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Slupsky CM, He X, Hernell O, Andersson Y, Rudolph C, Lonnerdal B, West CE. Postprandial metabolic response of breast-fed infants and infants fed lactose-free vs regular infant formula: A randomized controlled trial. Sci Rep. 2017 Jun 16;7(1):3640. doi: 10.1038/s41598-017-03975-4.
PubMed 28623320
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Serum Responses to Various Infant Formulas and Breast Milk in Infants- a Pilot Study
- ClinicalTrials.gov ID
- NCT02441296
- Acronym / sponsor ID
- 2013-152-31M
- Conditions
- Infant, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis, Mead Johnson Nutrition
- Study start
- Oct 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 May 2015 (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 optimal choice of carbohydrate in infant formula needs to be assessed in more detail. Lactose has conventionally been used in most milk-based infant formulas, but more recently lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity. However, the metabolic consequences have not been examined.
In a pilot study, the investigators will assess the postprandial metabolic response to a meal of formula with either lactose or maltodextrins. A breastfed reference group is also included.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formula with lactose | Experimental | Other: Formula with lactoseCarbohydrate-free formula with added lactose |
| Formula with maltodextrins | Experimental | Other: Formula with maltodextrinsCarbohydrate-free formula with added maltodextrins |
| Breastfeeding | No intervention | –Breastfed reference group |
Who may qualify
- Ages
- 3 to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy
- Term infants (gestational age 37-42 weeks)
- Birth weight 2500-4500g
Key exclusion criteria (3 listed)
- Infant illness
- Maternal diabetes
- Maternal pregnancy complications
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 |
|---|---|---|
| Formula with lactose | Other | Formula with lactose |
| Formula with maltodextrins | Other | Formula with maltodextrins |
Primary outcome
Glucose levels
Time frame: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
The change in serum glucose levels are monitored following a test meal from baseline to 15 min, 30 min, 60 min, 90 min and 120 minutes
2 secondary outcomes
Insulin levels
Time frame: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Metabolite levels
Time frame: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
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 4 Nov 2020.
- Results publication: PubMed 28623320Slupsky CM, He X, Hernell O, Andersson Y, Rudolph C, Lonnerdal B, West CE. Postprandial metabolic response of breast-fed infants and infants fed lactose-free vs regular infant formula: A randomized controlled trial. Sci Rep. 2017 Jun 16;7(1):3640. doi: 10.1038/s41598-017-03975-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Formula with lactose and Formula with maltodextrins in people with Infant and Metabolism, run by Umeå University.
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 3 inclusion and 3 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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Glucose levels (time frame: 2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02441296, which also lists 1 linked publication.
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 4 Nov 2020.