Healthy
Conditions
Keywords
Infant formula, body composition, safety
Brief summary
This is a multicentric, randomized, blinded, controlled trial to study the effects of a new infant formula on the changes in the newborn body composition over time: weight gain, anthropometric data, incidence of infections, digestive tolerance (flatulence, vomiting and regurgitation), feces (consistency and frequency), behavior (restlessness, colic, nocturnal awakenings), count of probiotic strains of the intestinal microbiota in feces, safety and tolerability of the investigational products (measured as number, frequency and severity of adverse events in all branches of the study)
Interventions
DIETARY_SUPPLEMENTNutribén Innova® 1
Infants are fed solely with infant formula supplemented with an inactive probiotic and omega 3 fatty acids over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's
DIETARY_SUPPLEMENTNutribén®
Infants are fed solely with infant formula over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's age.
DIETARY_SUPPLEMENTBreastfeed
Infants are breastfeeding solely over the first 6 months of their life, from then on the infants are fed as recommended by their caregiver, as if they are not participating in a research study.
Sponsors
Fundación Teófilo Hernando, Spain
Biopolis S.L.
Alter Farmacia, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
The 2 infant formula arms are blinded for the participant, investigator and data analyst. The 3rd arm is an open control group conformed by breastfeed infants
Eligibility
Sex/Gender
ALL
Age
15 Days to 25 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy children. Both sex. * Full term infants (between 37 and 42 weeks of pregnancy). * Birth weight between 2500 g- 4500 g. * Single birth babies. * BMI of the mothers before the pregnancy between 19 y 30 kg/m2.
Exclusion criteria
* Body weight lower than the 5th percentile for their gestational age. * Cow's milk protein allergy and/or lactose allergy. * Administration of antibiotics 7 days prior inclusion. * Congenital disease or malformation that may affect the infant growth rate. Population Description: The study population are newborns selected from primary care clinics in Spain. Sampling Method: Not applicable * Metabolic disease or disorders. * Significant prenatal disease and/or serious postnatal disease before recruitment. * Underage parents. * Diabetic mother. * Born from a drug abuse mother (who use abuse drugs during pregnancy). * Parents cannot comply with study procedures. * Subject included or that have been included in other clinical trial since his/her birth day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain at 6 months | 6 months after the beginning of the study | Measure of weight gain by grams/day between the first visit and month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length gain | 21 days, 2, 4, 6 and 12 months | Measure of the infant's length gain over time in cms |
| Head circumference gain | 21 days, 2, 4, 6 and 12 months | Measure of the increase of the head circumference over time in cms |
| Tricipital Skin fold development | 4, 6 and 12 months | Measurement of the development of tricipital skin fold, in cms, measured using a skinfold caliper |
| Subscapular skin fold develompent | 4, 6 and 12 months | Measurement of the development of subscapular skin fold, in cms, measured using a skinfold caliper |
| Mean arm circumference | 4, 6 and 12 months | Measure of arm circumference over time in cms. |
| Feces features consistency | 21 days, 2, 4, 6 and 12 months | Description of the consistency of baby's feces features, according to their parent's perception, on a qualitative scale: soft, hard, liquid, normal, semiliquid, pasty. The analysis includes the number of feces in each group and the overall frequency by study arm and visit. |
| Feces features number of bowel movements | 21 days, 2, 4, 6 and 12 months | Number of bowel movements per day sorted by study group |
| Digestive tolerance | 4, 6 and 12 months | The digestive tolerance will be assessed as adequate, constipation, flatulence, vomit or other distresses, which are a heterogeneous group that includes various affections as diarrhea, abdominal pain, irritability, constipation, regurgitation or colic. The analysis includes the overall number and the frequency sorted by study arm. |
| weight at 21 days, 2, 4, 6 and 12 months | 21 days, 2, 4, 6 and 12 months | Measure of weight gain by grams |
| intestinal microbiota | 4, 6 and 12 months | Analysis of the evolution of the intestinal microbiota of the children over the study. The richness and diversity of the microbiota are analyzed and compared between the study groups. |
| Evolution of calprotectin levels in feces | 21 days, 2, 6 and 12 months | Measurement of the evolution of calprotectin levels in feces over time |
| Evolution of IgA levels in feces | 21 days, 2, 6 and 12 months | Measurement of the evolution of IgA levels in feces over time |
| Evolution lactic acid levels in feces | 21 days, 2, 6 and 12 months | Measurement of the evolution of lactic acid levels in feces over time |
| Evolution of short-chain fatty acid levels in feces | 21 days, 2, 6 and 12 months | Measurement of the evolution of short-chain fatty acid levels in feces over time |
| Morbility | over a year | Analysis of the number and frequency of all adverse events registered during the study by feeding group |
| Products Tolerability | over a year | Quantitative variable. The tolerability of the products is assessed as adequate, good, very good, unsatisfactory. The analysis includes the overall number y and the relative frequency by group. |
| Overall rate of the products | 2, 4, 6 and 12 months | Quantitative variable. The parents' subjective rate of the products. The assessment can be, acceptable, good, very good, satisfactory or not satisfactory. |
| Infant's behavior | 4, 6 and 12 months | Qualitative variable. The infant's behavior is classified as either good or altered. The total number and the relative frequency by group are included in the analysis. |
Countries
Spain
Outcome results
None listed