Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2013-10-31
2016-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Formula with lactose
Carbohydrate-free formula with added lactose
Formula with lactose
Formula with maltodextrins
Carbohydrate-free formula with added maltodextrins
Formula with maltodextrins
Breastfeeding
Breastfed reference group
No interventions assigned to this group
Interventions
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Formula with lactose
Formula with maltodextrins
Eligibility Criteria
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Inclusion Criteria
* Term infants (gestational age 37-42 weeks)
* Birth weight 2500-4500g
Exclusion Criteria
* Maternal diabetes
* Maternal pregnancy complications
3 Months
3 Months
ALL
Yes
Sponsors
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University of California, Davis
OTHER
Mead Johnson Nutrition
INDUSTRY
UmeƄ University
OTHER
Responsible Party
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References
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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.
Other Identifiers
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2013-152-31M
Identifier Type: -
Identifier Source: org_study_id