Tolerance and Digestibility of a New Formula in Healthy Infants
Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants
1 other identifier
interventional
100
1 country
2
Brief Summary
The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2008
2 active sites
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
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 17, 2010
CompletedFirst Posted
Study publicly available on registry
August 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJanuary 26, 2011
January 1, 2011
2.1 years
August 17, 2010
January 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
digestibility of lipids in formula
lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake
during the 30d consumption period
Secondary Outcomes (1)
tolerance and growth
during the 30d of formula intake
Study Arms (2)
control formula
PLACEBO COMPARATORformula containing only vegetable fats
new formula
EXPERIMENTALnew formula with dairy lipids and soluble milk proteins
Interventions
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake
Eligibility Criteria
You may qualify if:
- normal growth;
- considered as healthy by the investigator according to the medical interrogation and the clinical examination;
- receiving exclusively infant formula for at least 15 days.
- without any solid food during the month of the study
You may not qualify if:
- Premature born children or small born weights;
- Children breast-fed or weaned for less than 15 days;
- Children with solid food
- Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
- Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
- Children under medical treatment (ex: paracetamol).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lactalislead
Study Sites (2)
Faculté de Médecine
Dijon, 21078, France
Hopital Mère-Enfants
Rennes, 35000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 17, 2010
First Posted
August 18, 2010
Study Start
November 1, 2008
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
January 26, 2011
Record last verified: 2011-01