Primary outcome of the study was defined as a difference in intestinal microbiota composition between MF and VF intervention. In total, 22 infants were enrolled in the study. Written informed parental consent was obtained for each infant from both parents. Exclusion criteria included severe acquired or congenital diseases, mental or physical disorders, any symptoms of allergy, parents or siblings with documented cow’s milk allergy, use of probiotics, antibiotics or other medication that treat or cause gastrointestinal symptoms, use of medication known or suspected to affect fat digestion, absorption and/or metabolism, such as nutritional supplements, suppositories, medication that may suppress or neutralize gastric acid secretion and gut motility and participation in another clinical trial. Complementary feeding was initiated only after the endpoint measurements. Infants were eligible for inclusion when they were healthy, full-term (gestational age ≥ 37 weeks) with a birth weight between the 10th and 90th percentiles, and exclusively formula-fed at least two weeks before enrolment and during the entire study. Infants were recruited during routine visits to their private paediatricians.
1PASSWORD AUTOMATIONSAWERSVENTUREBEAT FULL SIZE
VF standard formula with 100% vegetable fat source, MF test formula with 50% milk fat Full size image
1PASSWORD AUTOMATIONSAWERSVENTUREBEAT TRIAL
The trial was conducted in agreement with the International Conference on Harmonisation guidelines on Good Clinical Practice and was registered at the Dutch Trial Register () as NL7815.įig. The study was approved by the ethics committee of Harokopio University (Athens, Greece) and was conducted between May 2019 (first subject in) and November 2019 (last subject out) in Athens, Greece. The parents, paediatricians and statisticians were blinded to the IF. Upon enrolment, the infants were alternately allocated to consume the VF formula or a test formula with 50% milk fat and 50% vegetable fat (MF) in a 2 × 2 week crossover design after the run-in period (Fig. Upon inclusion in the study, the randomization was performed centrally, at Harokopio University, by a designated research assistant who assigned the participants to the treatment arms. Infants were enrolled in the study during routine visits to the study pediatricians. The total duration of the study was 6 weeks, including a 2-week run-in period during which the infants consumed standard IF with a 100% vegetable fat source (VF).
The clinical trial was a single-blinded, crossover, randomized, placebo-controlled study conducted with healthy, full-term, exclusively IF-fed infants.
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