Carbohydrate and Metabolism: a Pilot Study
Postprandial Serum Responses to Various Infant Formulas and Breast Milk in Infants- a Pilot Study
1 other identifier
interventional
30
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedNovember 4, 2020
November 1, 2020
2.4 years
April 8, 2015
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Secondary Outcomes (2)
Insulin levels
2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Metabolite levels
2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Study Arms (3)
Formula with lactose
EXPERIMENTALCarbohydrate-free formula with added lactose
Formula with maltodextrins
EXPERIMENTALCarbohydrate-free formula with added maltodextrins
Breastfeeding
NO INTERVENTIONBreastfed reference group
Interventions
Eligibility Criteria
You may qualify if:
- Healthy
- Term infants (gestational age 37-42 weeks)
- Birth weight 2500-4500g
You may not qualify if:
- Infant illness
- Maternal diabetes
- Maternal pregnancy complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
- University of California, Daviscollaborator
- Mead Johnson Nutritioncollaborator
Related Publications (1)
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.
PMID: 28623320RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2015
First Posted
May 12, 2015
Study Start
October 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
November 4, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share