scholarly journals An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial

Nutrients ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 2072 ◽  
Author(s):  
Jean-Charles Picaud ◽  
Barbara Pajek ◽  
Malgorzata Arciszewska ◽  
Izabela Tarczón ◽  
Joaquin Escribano ◽  
...  
Keyword(s):  
Weight Gain ◽  
Adverse Events ◽  
Whey Protein ◽  
Infant Formula ◽  
Reference Group ◽  
Daily Weight Gain ◽  
Intact Protein ◽  
Controlled Clinical Trial ◽  
Serious Adverse Events ◽  
Term Infants

The current study evaluates the safety and tolerance of a partially hydrolyzed whey protein-based infant formula (PHF) versus an in intact cow’s milk protein formula (IPF). Breastfed infants were included as a reference group. In a multi-country, multicenter, randomized, double-blinded, controlled clinical trial, infants whose mothers intended to fully formula feed were randomized to PHF (n = 134) or IPF (n = 134) from ≤14 days to 17 weeks of age. The equivalence analysis of weight gain per day within margins of +/−3 g/d (primary outcome), the recorded adverse events, growth and gastro-intestinal tolerance parameters were considered for the safety evaluation. Equivalence of weight gain per day from enrolment until 17 weeks of age was demonstrated in the PHF group compared to the IPF group (difference in means −1.2 g/d; 90% CI (−2.42; 0.02)), with estimated means (SE) of 30.2 (0.5) g/d and 31.4 (0.5) g/d, respectively. No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups. A partially hydrolyzed whey protein-based infant formula supports adequate infant growth, with a daily weight gain equivalent to a standard intact protein-based formula; it is also safe for use and well-tolerated in healthy term infants.

scholarly journals 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

2019 ◽  
Vol 109 (3) ◽  
pp. 586-596 ◽  
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.

scholarly journals A Partially Hydrolyzed Whey Infant Formula Supports Appropriate Growth: A Randomized Controlled Non-Inferiority Trial

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3056
Author(s):  
Eva Karaglani ◽  
Inge Thijs-Verhoeven ◽  
Marjan Gros ◽  
Christina Chairistanidou ◽  
Giorgos Zervas ◽  
...  
Keyword(s):  
Weight Gain ◽  
Infant Formula ◽  
Controlled Trial ◽  
Daily Weight Gain ◽  
Intact Protein ◽  
Control Group ◽  
Intervention Period ◽  
Term Infants ◽  
Randomized Controlled ◽  
Secondary Outcomes

The aim of the current study was to investigate the effects of a partially hydrolyzed whey infant formula (PHF) on growth in healthy term infants as compared to a standard infant formula with intact protein (IPF). In a double-blind, non-inferiority, randomized controlled trial, a total of 163 healthy formula-fed infants, 55–80 days old, were recruited and randomly allocated to either the PHF (test) or the IPF (control) group. They were followed up for three months during which they were evaluated monthly on growth and development. In total, 21 infants discontinued the study, while 142 infants completed the study (test n = 72, control n = 70). The primary outcome was daily weight gain during the three months. Secondary outcomes included additional anthropometric indices at every timepoint over the intervention period. Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of −3 g/day [mean difference (95% CI) test vs. control: −0.474 (−2.460, 1.512) g/day]. Regarding secondary outcomes, i.e., infants’ weight, length, head circumference, body mass index (BMI), and their Z-scores, no differences were observed between the two groups at any time point. The PHF resulted in similar infant growth outcomes as the standard IPF. Based on these results, it can be concluded that the partially hydrolyzed whey infant formula supports adequate growth in healthy term infants.

scholarly journals Normal Growth of Healthy Infants Born from HIV+ Mothers Fed a Reduced Protein Infant Formula Containing the Prebiotics Galacto-Oligosaccharides and Fructo-Oligosaccharides: A Randomized Controlled Trial

2015 ◽  
Vol 9 ◽  
pp. CMPed.S17841
Author(s):  
Hugo Da Costa Ribeiro Júnior ◽  
Tereza Cristina Medrado Ribeiro ◽  
Angela Peixoto De Mattos ◽  
Mariana Pontes ◽  
Roseli Oselka Saccardo Sarni ◽  
...  
Keyword(s):  
Weight Gain ◽  
Infant Formula ◽  
Controlled Trial ◽  
Normal Growth ◽  
Daily Weight Gain ◽  
Term Infants ◽  
Intention To Treat ◽  
Formula Group ◽  
The Difference ◽  
Breast Fed

Objective The aim of the current study was to evaluate the safety of a new reduced protein (2.1 g/100 kcal) infant formula containing 4 g/L of 90% galacto-oligosaccharides (GOS) and 10% fructo-oligosaccharides (FOS). Methods Healthy term infants from Brazil were enrolled. Those born to human immunodeficiency virus (HIV)-positive mothers were randomized to a test ( n = 65) or control ( n = 63) formula group. Infants born to HIV-negative mothers were either exclusively breast-fed ( n = 79) or received a mixed diet (breast milk and test formula, n = 65). Between 2 weeks and 4 months of age, infants were exclusively fed according to their assigned group. Anthropometric measurements were taken at baseline, 1, 2, 3, 4, 6, 8, 10, and 12 months. Digestive tolerance was evaluated during the first 4 months. The primary outcome was mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups. Results Data from all infants ( N = 272) were used in the intention-to-treat (ITT) analysis and data from 230 infants were used in the per-protocol (PP) analysis. The difference in mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups was 1.257 g/day (onesided 95% confidence interval [CI]: -0.705 to inf, P < 0.001) in the PP analysis, showing that the lower bound of the 95% CI was above the -3.0 g/day non-inferiority margin. Results were similar in the ITT analysis. Symptoms of digestive tolerance and frequency of adverse events were similar in the two groups. Conclusions The formula containing 2.1 g/100 kcal protein and GOS and FOS was safe and tolerated well.

scholarly journals Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study

2016 ◽  
Vol 5 ◽  
Author(s):  
M. Abrahamse-Berkeveld ◽  
M. Alles ◽  
E. Franke-Beckmann ◽  
K. Helm ◽  
R. Knecht ◽  
...  
Keyword(s):  
Weight Gain ◽  
Adverse Events ◽  
Blood Parameters ◽  
Daily Weight Gain ◽  
Control Group ◽  
Double Blind ◽  
Term Infants ◽  
Bifidobacterium Breve ◽  
Randomised Controlled ◽  
Hydrolysed Formula

AbstractThe objective of the present study was to evaluate the growth and tolerance in healthy, term infants consuming a synbiotic formula with daily weight gain as the primary outcome. In a randomised, controlled, double-blind, multicentre, intervention study infants were assigned to an extensively hydrolysed formula containing a specific combination of Bifidobacterium breve M-16V and a prebiotic mixture (short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides in a 9:1 ratio; scGOS/lcFOS; synbiotic group), or the same formula without this synbiotic concept for 13 weeks (control group). Anthropometry, formula intake, tolerance, stool characteristics, blood parameters, faecal microbiota and metabolic faecal profile were assessed. Medically confirmed adverse events were recorded throughout the study. Equivalence in daily weight gain was demonstrated for the intention-to-treat (ITT) population (n 211). In the per-protocol (PP) population (n 102), the 90 % CI of the difference in daily weight gain slightly crossed the lower equivalence margin. During the intervention period, the mean weight-for-age and length-for-age values were close to the median of the WHO growth standards in both groups, indicating adequate growth. The number of adverse events was not different between both groups. No relevant differences were observed in blood parameters indicative for liver and renal function. At 13 weeks, an increased percentage of faecal bifidobacteria (60 v. 48 %) and a reduced percentage of Clostridium lituseburense/C. histolyticum (0·2 v. 2·6 %) were observed in the synbiotic group (n 19) compared with the control group (n 27). In conclusion, this study demonstrates that an extensively hydrolysed formula with B. breve M-16V and the prebiotic mixture scGOS/lcFOS (9:1) supports an adequate infant growth.

scholarly journals Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1654
Author(s):  
Jacques Rigo ◽  
Stefanie Schoen ◽  
Marc Verghote ◽  
Bart van Overmeire ◽  
Wivinne Marion ◽  
...  
Keyword(s):  
Weight Gain ◽  
Protein Content ◽  
G Protein ◽  
Child Growth ◽  
Infant Growth ◽  
World Health ◽  
Daily Weight Gain ◽  
Term Infants ◽  
Growth Standards ◽  
Content Support

The current study aimed to investigate growth, safety and tolerance of partially hydrolysed infant formulae in healthy full-term infants. Fully formula-fed infants were randomised ≤14 days of age to receive a partially hydrolysed whey formula with 2.27 g protein/100 kcal (pHF2.27) or the same formula with 1.8 g or 2.0 g protein/100 kcal (pHF1.8 and pHF2.0) until 4 months of age. The primary outcome was equivalence in daily weight gain within margins of ± 3 g/day; comparison with WHO Child Growth Standards; gastrointestinal tolerance parameters and number of (serious) adverse events were secondary outcomes. A total of 207 infants were randomised, and 61 (pHF1.8), 46 (pHF2.0) and 48 (pHF2.27) infants completed the study per protocol. Equivalence in daily weight gain was demonstrated for the comparison of pHF1.8 and pHF2.27, i.e., the estimated difference was −1.12 g/day (90% CI: [−2.72; 0.47]) but was inconclusive for the comparisons of pHF2.0 and pHF2.27 with a difference of −2.52 g/day (90% CI: [−4.23; −0.81]). All groups showed adequate infant growth in comparison with the World Health Organization (WHO) Child Growth Standards. To conclude, the evaluated partially hydrolysed formulae varying in protein content support adequate growth and are safe and well tolerated in healthy infants.

scholarly journals Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1530 ◽  
Author(s):  
Alfonso Rodriguez-Herrera ◽  
Kelly Mulder ◽  
Hetty Bouritius ◽  
Rocio Rubio ◽  
Antonio Muñoz ◽  
...  
Keyword(s):  
Infant Formula ◽  
Reference Group ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Daily Weight Gain ◽  
Control Group ◽  
Double Blind ◽  
Control Infant ◽  
Breastfed Infants ◽  
Experimental Versus

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants.

scholarly journals Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
David H. Adams ◽  
Lu Zhang ◽  
Brian A. Millen ◽  
Bruce J. Kinon ◽  
Juan-Carlos Gomez
Keyword(s):  
Weight Gain ◽  
Adverse Events ◽  
Term Treatment ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Treatment Groups ◽  
Long Term Treatment ◽  
Blind Comparison

We tested the hypothesis that long-term treatment with pomaglumetad methionil would demonstrate significantly less weight gain than aripiprazole in patients with schizophrenia. In this 24-week, multicenter, randomized, double-blind, Phase 3 study, 678 schizophrenia patients were randomized to either pomaglumetad methionil (n=516) or aripiprazole (n=162). Treatment groups were also compared on efficacy and various safety measures, including serious adverse events (SAEs), discontinuation due to adverse events (AEs), treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), and suicide-related thoughts and behaviors. The pomaglumetad methionil group showed significantly greater weight loss at Week 24 (Visit 12) compared with the aripiprazole group (−2.8 ± 0.4 versus 0.4 ± 0.6;P<0.001). However, change in Positive and Negative Syndrome Scale (PANSS) total scores for aripiprazole was significantly greater than for pomaglumetad methionil (−15.58 ± 1.58 versus −12.03 ± 0.99;P=0.045). The incidences of SAEs (8.2% versus 3.1%;P=0.032) and discontinuation due to AEs (16.2% versus 8.7%;P=0.020) were significantly higher for pomaglumetad methionil compared with aripiprazole. No statistically significant differences in the incidence of TEAEs, EPS, or suicidal ideation or behavior were noted between treatment groups. In conclusion, long-term treatment with pomaglumetad methionil resulted in significantly less weight gain than aripiprazole. This trial is registered with ClinicalTrials.govNCT01328093.

Clinical efficacy and tolerability of 2.5 mg zolmitriptan for the acute treatment of migraine

Neurology ◽  
1997 ◽  
Vol 49 (5) ◽  
pp. 1219-1225 ◽  
Author(s):  
G. D. Solomon ◽  
R. K. Cady ◽  
J. A. Klapper ◽  
N. L. Earl ◽  
J. R. Saper ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Efficacy ◽  
Acute Treatment ◽  
Age At Onset ◽  
Controlled Clinical Trial ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Good Tolerability ◽  
Male Patients ◽  
Severe Migraine

Previous studies demonstrated that zolmitriptan at doses of 1 to 25 mg was highly effective in treating acute migraine attacks. The 2.5-mg dose had a favorable therapeutic effect with high efficacy and good tolerability. The objective of this study was to further evaluate the efficacy of a single 2.5-mg dose of zolmitriptan (Zomig, formerly known as 311C90) for acute treatment of a single moderate or severe migraine attack. The study was a randomized, double-blind, placebo-controlled clinical trial. Female and male patients, 12 to 65 years old, with migraine (with or without aura) for ≥1 year, one to six migraines per month, and age at onset < 50 years were included; 327 patients were screened and randomized to receive either zolmitriptan (n = 219) or placebo (n = 108). Patients treated a single moderate or severe migraine headache with 2.5 mg zolmitriptan or placebo and recorded clinical efficacy and adverse events on a diary form. Headache response at 2 hours was 62% for zolmitripan compared with 36% for placebo(p < 0.001); at 4 hours, headche response was 70% with zolmitriptan and 37% with placebo (p < 0.001). Headache recurrence in patients treated with 2.5 mg zolmitriptan was 22% (versus placebo 30%). The headache response at 4 hours, pain-free rate, and response rate of nonheadache symptoms favored zolmitriptan over placebo. No serious adverse events were associated with zolmitriptan treatment. A 2.5-mg dose of zolmitriptan is clinically effective and well tolerated for the acute treatment of migraine.

scholarly journals Risk of Adverse Outcomes in Females Taking Oral Creatine Monohydrate: A Systematic Review and Meta-Analysis

Nutrients ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1780
Author(s):  
Deborah L. de Guingand ◽  
Kirsten R. Palmer ◽  
Rodney J. Snow ◽  
Miranda L. Davies-Tuck ◽  
Stacey J. Ellery
Keyword(s):  
Weight Gain ◽  
Adverse Events ◽  
Meta Analysis ◽  
Creatine Supplementation ◽  
Hepatic Function ◽  
Creatine Monohydrate ◽  
Adverse Outcomes ◽  
Post Intervention ◽  
Serious Adverse Events ◽  
Significant Difference

Creatine Monohydrate (CrM) is a dietary supplement routinely used as an ergogenic aid for sport and training, and as a potential therapeutic aid to augment different disease processes. Despite its increased use in recent years, studies reporting potential adverse outcomes of CrM have been mostly derived from male or mixed sex populations. A systematic search was conducted, which included female participants on CrM, where adverse outcomes were reported, with meta-analysis performed where appropriate. Six hundred and fifty-six studies were identified where creatine supplementation was the primary intervention; fifty-eight were female only studies (9%). Twenty-nine studies monitored for adverse outcomes, with 951 participants. There were no deaths or serious adverse outcomes reported. There were no significant differences in total adverse events, (risk ratio (RR) 1.24 (95% CI 0.51, 2.98)), gastrointestinal events, (RR 1.09 (95% CI 0.53, 2.24)), or weight gain, (mean difference (MD) 1.24 kg pre-intervention, (95% CI −0.34, 2.82)) to 1.37 kg post-intervention (95% CI −0.50, 3.23)), in CrM supplemented females, when stratified by dosing regimen and subject to meta-analysis. No statistically significant difference was reported in measures of renal or hepatic function. In conclusion, mortality and serious adverse events are not associated with CrM supplementation in females. Nor does the use of creatine supplementation increase the risk of total adverse outcomes, weight gain or renal and hepatic complications in females. However, all future studies of creatine supplementation in females should consider surveillance and comprehensive reporting of adverse outcomes to better inform participants and health professionals involved in future trials.

scholarly journals Semi-Intensive Fattening Suitability and Slaughter Value of Young Bulls of Three Polish Native Breeds in Comparison With Polish Holstein-Friesian and Simmental

2014 ◽  
Vol 14 (2) ◽  
pp. 453-460 ◽  
Author(s):  
Zygmunt Litwińczuk ◽  
Paweł Żółkiewski ◽  
Mariusz Florek ◽  
Witold Chabuz ◽  
Piotr Domaradzki
Keyword(s):  
Weight Gain ◽  
Reference Group ◽  
Daily Weight Gain ◽  
White Variety ◽  
Black And White ◽  
Holstein Friesian ◽  
Good Material ◽  
Fattening Period ◽  
The Difference ◽  
Intensive System

Abstract An evaluation was conducted of the suitability for fattening in a semi-intensive system (mainly with fodders from permanent grassland) and the slaughter value of 15 young bulls of the Polish Red (PR) breed and 10 each of the White-Backed (WB) and Polish Black-and-White (BW) breeds. The reference group consisted of young bulls of the Black-and-White variety of the Polish Holstein- Friesian (HF) breed and the Simmental (SIM) breed, fattened on the same farms. Control fattening was carried out until the age of 18 months. Mean daily weight gain in the bulls of the native breeds during the control fattening period (which lasted 314-358 days) was 0.9 kg, similarly to HF, but significantly lower (P≤0.05) than in the Simmentals (986 g). During the entire fattening period, i.e. from birth to the age of 18 months, daily weight gain was 832 g in PR and 889-919 g in WB and BW. Dressing percentage was lowest in PR bulls (51.69%), and higher in WB (53.1%) and BW (53.49%), with values similar to the reference group, i.e. young bulls of the Simmental (52.97%) and HF (53.29%) breeds. The difference between PR and BW (1.8%) and HF (1.6%) was statistically significant (P≤0.05). In the EUROP classification system, the carcasses of the young bulls of the native breeds were most often placed in classes R- and O+ (conformation) and 2+ and 3- (fat cover), as in the case of young HF bulls. Carcasses of young Simmental bulls were assigned to much higher classes. The young bulls of the three Polish native breeds evaluated are good material for fattening in a semi-intensive system (mainly with fodder from permanent grasslands), while the young PR bulls were the least suitable

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