THE CLINICAL EFFECT OF A NEW INFANT FORMULA IN TERM INFANTS WITH CONSTIPATION: A DOUBLE-BLIND, RANDOMIZED TRIAL.

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti®Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.

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Intravenous Maprotiline in Severe and Resistant Primary Depression: A Double-Blind Comparison with Clomipramine

Journal of International Medical Research ◽

10.1177/030006058301100203 ◽

1983 ◽

Vol 11 (2) ◽

pp. 78-84 ◽

Cited By ~ 5

Author(s):

F Drago ◽

A Motta ◽

E Grossi

Keyword(s):

Randomized Trial ◽

Older Patients ◽

Clinical Effect ◽

Response Rates ◽

Intravenous Route ◽

Double Blind ◽

Clinical Variables ◽

Female Patients ◽

Number Of Patients ◽

Blind Comparison

A double-blind, randomized trial is described which was designed to compare the clinical effect of 100 mg daily of maprotiline (Ludiomil®) and of clomipramine (Anafranil®) given by the intravenous route in forty hospitalized female patients with severe and resistant primary depression. Physicians' assessment of patients' progress was made following 5, 9 and 21 days of treatment. The response rates to maprotiline and clomipramine were not significantly different even if a greater number of patients responded to clomipramine. None of the demographic and clinical variables considered could be identified as factor predicting the response to maprotiline and to clomipramine, even if a trend for a preferential responsiveness to clomipramine in the older patients was observed.

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Milk fat-based formula reduced palmitic acid soaps and excretion of calcium in healthy term infants: two double-blind, randomized, cross-over trials

Proceedings of The Nutrition Society ◽

10.1017/s0029665120002165 ◽

2020 ◽

Vol 79 (OCE2) ◽

Author(s):

Yannis Manios ◽

Eva Karaglani ◽

Inge Thijs-Verhoeven ◽

Elpis Vlachopapadopoulou ◽

Anastasia Papazoglou ◽

...

Keyword(s):

Palmitic Acid ◽

Infant Formula ◽

Milk Fat ◽

Bovine Milk ◽

Calcium Excretion ◽

Double Blind ◽

Term Infants ◽

Stool Samples ◽

To Receive ◽

Vegetable Fat

AbstractIntroduction:Infant formula (IF) with vegetable fat blends typically have more than 80% of palmitic acid (PA) esterified at the sn-1 and sn-3 positions of triglycerides. Additional use of bovine milk fat (MF), a natural source of sn-2 palmitate, may enable increasing the sn-2 palmitate levels, potentially leading to improved absorption of fatty acids and calcium, and reduced formation of PA soaps associated with constipation in infants. The current study investigated the effect of IF with and without MF on the concentration of PA, PA soaps, calcium excretion and gastrointestinal tolerance using Amsterdam Infant Stool Scale (AISS) in healthy term infants.Materials and Methods:Two double-blind randomized placebo-controlled cross-over trials were conducted in parallel to compare a MF-based test formula with high sn-2 palmitate levels (39%) with a reference formula with only vegetable fat (10.1% sn-2 palmitate, cross-over study 1; CS1) and a MF-based test formula with medium sn-2 palmitate levels (19.7%) with the reference formula with only vegetable fat (cross-over study 2; CS2). CS1 included 17 and CS2 18 full-term, healthy, exclusively formula-fed infants screened between the 9th-14th week of age. After two weeks of wash-out period, in both CS1 and CS2, infants were randomized to receive either the MF-based test formula or reference. At the end of two weeks, the groups were crossed-over to receive the other formula for subsequent two weeks. Stool samples were collected after each two-week intervention period and bi-weekly diaries and questionnaires were completed by the parents/caretakers.Results:The PA concentrations in stools (mg/g dry weight) did not differ between the MF-based test and reference formula in either CS1 (p = 0.1324) or CS2 (p = 0.1198). A reduction was observed in the concentration of PA soaps in both medium and high sn-2 palmitate formula, with a more pronounced effect for the high sn-2 palmitate formula (medium; p = 0.0023 and high; p < 0.0001). In addition, calcium excretion in stools was significantly lower in the MF-based formula groups as compared to the reference in both studies (medium; p = 0.0067 and high; p = 0.0041). In CS2, stool consistency did not differ between groups whilst in CS1, a favorable effect of high sn-2 palmitate formula compared to the reference formula (p = 0.0008) was noted.Conclusion:Bovine milk fat in infant formula reduced the excretion of PA soaps and calcium in stool samples of healthy term infants. High sn-2 palmitate formula showed a more pronounced effect and improved stool consistency according to the AISS.

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Reducing Iron Content in Infant Formula from 8 to 2 mg/L Does Not Increase the Risk of Iron Deficiency at 4 or 6 Months of Age: A Randomized Controlled Trial

Nutrients ◽

10.3390/nu13010003 ◽

2020 ◽

Vol 13 (1) ◽

pp. 3

Author(s):

Maria Björmsjö ◽

Olle Hernell ◽

Bo Lönnerdal ◽

Staffan K. Berglund

Keyword(s):

Breast Milk ◽

Iron Deficiency ◽

Infant Formula ◽

Iron Content ◽

Iron Status ◽

Controlled Trial ◽

Bovine Lactoferrin ◽

High Concentration ◽

Double Blind ◽

Term Infants

Many infant formulas are fortified with iron at 8–14 mg/L whereas breast milk contains about 0.3 mg/L. Another major difference between breast milk and infant formula is its high concentration of lactoferrin, a bioactive iron-binding protein. The aim of the present study was to investigate how reducing the iron content and adding bovine lactoferrin to infant formula affects iron status, health and development. Swedish healthy full-term formula-fed infants (n = 180) were randomized in a double-blind controlled trial. From 6 weeks to 6 months of age, 72 infants received low-iron formula (2 mg/L) fortified with bovine lactoferrin (1.0 g/L) (Lf+), 72 received low-iron formula un-fortified with lactoferrin (Lf−) and 36 received standard formula with 8 mg of iron/L and no lactoferrin fortification as controls (CF). Iron status and prevalence of iron deficiency (ID) were assessed at 4 and 6 months. All iron status indicators were unaffected by lactoferrin. At 4 and 6 months, the geometric means of ferritin for the combined low-iron groups compared to the CF-group were 67.7 vs. 88.7 and 39.5 vs. 50.9 µg/L, respectively (p = 0.054 and p = 0.056). No significant differences were found for other iron status indicators. In the low-iron group only one infant (0.7%) at 4 months and none at 6 months developed ID. Conclusion: Iron fortification of 2 mg/L is an adequate level during the first half of infancy for healthy term infants in a well-nourished population. Adding lactoferrin does not affect iron status.

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Double-blind, randomized trial of a synthetic triacylglycerol in formula-fed term infants: effects on stool biochemistry, stool characteristics, and bone mineralization

American Journal of Clinical Nutrition ◽

10.1093/ajcn/70.5.920 ◽

1999 ◽

Vol 70 (5) ◽

pp. 920-927 ◽

Cited By ~ 130

Author(s):

Kathy Kennedy ◽

Mary S Fewtrell ◽

Ruth Morley ◽

Rebecca Abbott ◽

Peter T Quinlan ◽

...

Keyword(s):

Randomized Trial ◽

Bone Mineralization ◽

Double Blind ◽

Term Infants

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An infant formula with large, milk phospholipid–coated lipid droplets containing a mixture of dairy and vegetable lipids supports adequate growth and is well tolerated in healthy, term infants

American Journal of Clinical Nutrition ◽

10.1093/ajcn/nqy322 ◽

2019 ◽

Vol 109 (3) ◽

pp. 586-596 ◽

Cited By ~ 8

Author(s):

Laura M Breij ◽

Marieke Abrahamse-Berkeveld ◽

Yvan Vandenplas ◽

Sabine N J Jespers ◽

Amerik C de Mol ◽

...

Keyword(s):

Weight Gain ◽

Adverse Events ◽

Human Milk ◽

Infant Formula ◽

Lipid Droplets ◽

Daily Weight Gain ◽

Milk Lipid ◽

Double Blind ◽

Term Infants ◽

Breastfed Infants

ABSTRACT Background Lipid droplets in human milk have a mode diameter of ∼4 μm and are surrounded by a native phospholipid-rich membrane. Current infant milk formulas (IMFs) contain small lipid droplets (mode diameter ∼0.5 μm) primarily coated by proteins. A concept IMF was developed mimicking more closely the structure and composition of human milk lipid droplets. Objectives This randomized, controlled, double-blind equivalence trial evaluates the safety and tolerance of a concept IMF with large, milk phospholipid–coated lipid droplets (mode diameter 3–5 μm) containing vegetable and dairy lipids in healthy, term infants. Methods Fully formula-fed infants were enrolled up to 35 d of age and randomly assigned to 1 of 2 formulas until 17 wk of age: 1) Control IMF with small lipid droplets containing vegetable oils (n = 108); or 2) Concept IMF with large, milk phospholipid–coated lipid droplets comprised of 48% dairy lipids (n = 115). A group of 88 breastfed infants served as reference. Primary outcome was daily weight gain during intervention. Additionally, number and type of adverse events, growth, and tolerance parameters were monitored. Results Equivalence of daily weight gain was demonstrated (Concept compared with Control IMF: −1.37 g/d; 90% CI: −2.71, −0.02; equivalence margin ± 3 g/d). No relevant group differences were observed in growth, tolerance and number, severity, or relatedness of adverse events. We did observe a higher prevalence of watery stools in the Concept than in the Control IMF group between 5 and 12 wk of age (P < 0.001), closer to the stool characteristics observed in the breastfed group. Conclusions An infant formula with large, milk phospholipid–coated lipid droplets containing dairy lipids is safe, well tolerated, and supports an adequate growth in healthy infants. This trial was registered in the Dutch Trial Register (www.trialregister.nl) as NTR3683.

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A Partly Fermented Infant Formula with Postbiotics Including 3′-GL, Specific Oligosaccharides, 2′-FL, and Milk Fat Supports Adequate Growth, Is Safe and Well-Tolerated in Healthy Term Infants: A Double-Blind, Randomised, Controlled, Multi-Country Trial

Nutrients ◽

10.3390/nu12113560 ◽

2020 ◽

Vol 12 (11) ◽

pp. 3560

Author(s):

Yvan Vandenplas ◽

Virginie de Halleux ◽

Małgorzata Arciszewska ◽

Piotr Lach ◽

Valeriy Pokhylko ◽

...

Keyword(s):

Weight Gain ◽

Infant Formula ◽

Milk Fat ◽

Controlled Trial ◽

Gastrointestinal Symptoms ◽

Test Group ◽

Control Group ◽

Anthropometric Measures ◽

Double Blind ◽

Term Infants

This study investigated growth, safety, and tolerance in healthy infants consuming a partly fermented infant formula (IF) with postbiotics, 2′-linked fucosyllactose (2′-FL), a specific prebiotic mixture of short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS), and milk fat. This double-blind, controlled trial randomised 215 fully IF-fed infants ≤ 14 days of age to either: Test Group (IF) containing 26% fermented formula with postbiotics derived from Lactofidus fermentation process (including 3′-Galactosyllactose; 3′-GL), 0.8 g/100 mL scGOS/lcFOS (9:1), 0.1 g/100 mL 2′-FL, and milk fat), or Control group (IF with 0.8 g/100 mL scGOS/lcFOS (9:1)) until 17 weeks of age. Fully breastfed infants were included as a reference. Anthropometric measures, gastrointestinal symptoms, and safety were assessed monthly. Equivalence in weight gain (primary outcome) between the Test and Control groups was confirmed (difference in means −0.08 g/day; 90% CI (−1.47;1.31)) with estimated mean weight gain (SE) of 31.00 (0.59) g/day and 31.08 (0.60) g/day, respectively, (PP population, n = 196). Equivalence in length and head circumference gain between the randomised groups was also confirmed. No statistically significant differences were observed in adverse events or gastrointestinal tolerance between randomised IF groups. A partly fermented IF with postbiotics, specific oligosaccharides, 2′-FL, and milk fat supports adequate infant growth and is safe and well-tolerated in healthy term infants.

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Visual acuity and cognitive outcomes at 4 years of age in a double-blind, randomized trial of long-chain polyunsaturated fatty acid-supplemented infant formula

Early Human Development ◽

10.1016/j.earlhumdev.2006.11.003 ◽

2007 ◽

Vol 83 (5) ◽

pp. 279-284 ◽

Cited By ~ 162

Author(s):

Eileen E. Birch ◽

Sharon Garfield ◽

Yolanda Castañeda ◽

Dianna Hughbanks-Wheaton ◽

Ricardo Uauy ◽

...

Keyword(s):

Visual Acuity ◽

Fatty Acid ◽

Randomized Trial ◽

Infant Formula ◽

Polyunsaturated Fatty Acid ◽

Cognitive Outcomes ◽

Chain Polyunsaturated Fatty Acid ◽

Double Blind ◽

Long Chain

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Safety of supplementing infant formula with long-chain polyunsaturated fatty acids and Bifidobacterium lactis in term infants: a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114508084080 ◽

2009 ◽

Vol 101 (11) ◽

pp. 1706-1713 ◽

Cited By ~ 26

Author(s):

Robert A. Gibson ◽

Denis Barclay ◽

Helen Marshall ◽

Julie Moulin ◽

Jean-Claude Maire ◽

...

Keyword(s):

Weight Gain ◽

Infant Formula ◽

Head Circumference ◽

Controlled Trial ◽

Double Blind ◽

Term Infants ◽

Bifidobacterium Lactis ◽

Significant Difference ◽

Formula Group ◽

Long Chain

Probiotics and long-chain PUFA (LC-PUFA) may be beneficial supplements for infants who are not breast-fed. The aim of the present study is to evaluate the safety of an infant formula containing the LC-PUFA DHA and arachidonic acid (AA) and the probiotic Bifidobacterium lactis by comparing the growth rate of infants fed the supplemented and unsupplemented formulas. One hundred and forty-two healthy, term infants were enrolled in a single-centre, randomised, double-blind, controlled, parallel-group trial, and allocated to receive either standard or probiotic and LC-PUFA-containing experimental formulas. The infants were fed with their assigned formulas for 7 months. The primary outcome (weight gain) and the secondary outcomes (length, head circumference and formula tolerance) were measured throughout the study. LC-PUFA status was assessed at 4 months of age and immune response to childhood vaccines was measured at 7 months of age. There was no significant difference in growth between the two groups. The 90 % CI for the difference in mean weight gain was − 0·08, 3·1 g in the intention-to-treat population and 0·1–3·8 g in the per protocol population, which lay within the predefined boundaries of equivalence, − 3·9–3·9. There were no significant differences in mean length and head circumference. DHA and AA concentrations were higher in infants in the experimental formula group compared with the control formula group. No influence of the supplements on the response to vaccines was observed. Growth characteristics of term infants fed the starter formula containing a probiotic and LC-PUFA were similar to standard formula-fed infants.

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