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 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 Oral administration of Bifidobacterium breve B-3 modifies metabolic functions in adults with obese tendencies in a randomised controlled trial

2015 ◽  
Vol 4 ◽  
Author(s):  
Jun-ichi Minami ◽  
Shizuki Kondo ◽  
Naotake Yanagisawa ◽  
Toshitaka Odamaki ◽  
Jin-zhong Xiao ◽  
...  
Keyword(s):  
Fat Mass ◽  
Controlled Trial ◽  
High Sensitivity ◽  
Blood Parameters ◽  
Double Blind ◽  
Bifidobacterium Breve ◽  
Reactive Protein ◽  
Diet Induced Obesity ◽  
Metabolic Functions ◽  
Randomised Controlled

AbstractAccumulating evidence suggests an association between gut microbiota and the development of obesity, raising the possibility of probiotic administration as a therapeutic approach. Bifidobacterium breve B-3 was found to exhibit an anti-obesity effect on high-fat diet-induced obesity mice. In the present study, a randomised, double-blind, placebo-controlled trial was conducted to evaluate the effect of the consumption of B. breve B-3 on body compositions and blood parameters in adults with a tendency for obesity. After a 4-week run-in period, the participants were randomised to receive either placebo or a B-3 capsule (approximately 5 × 1010 colony-forming units of B-3/d) daily for 12 weeks. A significantly lowered fat mass was observed in the B-3 group compared with the placebo group at week 12. Improvements were observed for some blood parameters related to liver functions and inflammation, such as γ-glutamyltranspeptidase and high-sensitivity C-reactive protein. Significant correlations were found between the changed values of some blood parameters and the changed fat mass in the B-3 group. These results suggest the beneficial potential of B. breve B-3 in improving metabolic disorders.

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 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 ◽  
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.

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 Molecular Ecological Analysis of Fecal Bacterial Populations from Term Infants Fed Formula Supplemented with Selected Blends of Prebiotics

2008 ◽  
Vol 75 (4) ◽  
pp. 1121-1128 ◽  
Author(s):  
Noriko Nakamura ◽  
H. Rex Gaskins ◽  
Chad T. Collier ◽  
Gerardo M. Nava ◽  
Deshanie Rai ◽  
...  
Keyword(s):  
Bacterial Community ◽  
Adverse Events ◽  
Denaturing Gradient Gel Electrophoresis ◽  
Fecal Microbiota ◽  
Control Group ◽  
Rrna Gene ◽  
Double Blind ◽  
Term Infants ◽  
Bacterial Populations ◽  
Age Related

ABSTRACT Supplementation of infant formulas with prebiotic ingredients continues the effort to mimic functional properties of human milk. In this double-blind, controlled, 28-day study, healthy term infants received control formula (control group; n = 25) or control formula supplemented with polydextrose (PDX) and galactooligosaccharide (GOS) (4 g/liter) (PG4 group; n = 27) or with PDX, GOS, and lactulose (LOS) (either 4 g/liter [PGL4 group; n = 27] or 8 g/liter [PGL8 group; n = 25]). A parallel breast-fed group (BF group) (n = 30) was included. Stool characteristics, formula tolerance, and adverse events were monitored. Fecal bacterial subpopulations were evaluated by culture-based selective enumeration (Enterobacteriaceae), quantitative real-time PCR (Clostridium clusters I, XI, and XIV, Lactobacillus, and Bifidobacterium), and fluorescence in situ hybridization (FISH) (Bifidobacterium). Fecal bacterial community profiles were examined by using 16S rRNA gene PCR-denaturing gradient gel electrophoresis. The daily stool consistency was significantly softer or looser in the BF group than in all of the groups that received formula. The formulas were well tolerated, and the incidences of adverse events did not differ among feeding groups. Few significant changes in bacterial subpopulations were observed at any time point. The bacterial communities were stable; individual profiles tended to cluster by subject rather than by group. Post hoc analysis, however, demonstrated that the bacterial community profiles for subjects in the BF, PG4, PGL4, and PGL8 groups that first received formula at a younger age were less stable than the profiles for subjects in the same groups that received formula at an older age, but there was no difference for the control group. These data indicate that formulas containing PDX, GOS, and LOS blends are more likely to influence gut microbes when administration is begun in early infancy and justify further investigation of the age-related effects of these blends on fecal microbiota.

scholarly journals Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in Healthy Term Infants

2014 ◽  
Vol 8 ◽  
pp. CMPed.S16962 ◽  
Author(s):  
Claude Billeaud ◽  
Giuseppe Puccio ◽  
Elie Saliba ◽  
Bernard Guillois ◽  
Carole Vaysse ◽  
...  
Keyword(s):  
Weight Gain ◽  
Milk Fat ◽  
Bovine Milk ◽  
Control Group ◽  
Infant Formulas ◽  
Term Infants ◽  
Milk Fat Globule Membrane ◽  
Standard Formula ◽  
Milk Fat Globule ◽  
Fat Globule

Objective This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions. Methods Healthy, full-term infants ( n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: –3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated. Results Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]). Conclusion Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group.

scholarly journals Effect of Dietary Additives on Rabbit Performance, Carcass Traits and Some Blood Constituents under Egyptation Summer Season

2017 ◽  
Vol 10 (1) ◽  
pp. 139
Author(s):  
Sara Khalil Sherif
Keyword(s):  
Body Weight ◽  
Weight Gain ◽  
Organic Acids ◽  
Carcass Traits ◽  
Blood Parameters ◽  
Summer Season ◽  
Feed Additives ◽  
Daily Weight Gain ◽  
Feed Conversion ◽  
Blood Constituents

Sixty 7-week-old New Zealand White rabbits were randomly distributed into 5 equal experimental groups. The experimental rabbits were fed the tested diets till 14 weeks of age during summer season. The basal diet without feed additives (control; T1) and the other experimental diets were supplemented with enzymes at 0.5 g/kg (T2), organic acids at 1.0 g/kg (T3), Beta-pro at 0.2 g/kg (T4) or their combination (T5). The criteria of response were body weight, weight gain, feed consumption, feed conversion ratio, some blood constituents, carcass traits and economic efficiency. The obtained results can be summarized as follows: Positive effects of feed additives were observed on live body weight, daily weight gain and feed conversion of growing rabbits. There were no significant effects on blood parameters or carcass traits due to feed additives. It can be concluded that dietary Beta-pro (enzymes+probiotics) or a combination of enzymes, organic acids and Beta-pro at the tested levels can be used to improve the rabbit performance, with no adverse effects on carcass characteristics or blood parameters.

scholarly journals Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037842
Author(s):  
Wei Chen ◽  
Naya Huang ◽  
Haiping Mao ◽  
Xiao Yang ◽  
Qian Zhou ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Cardiovascular Outcomes ◽  
Control Group ◽  
Type I ◽  
Dialysis Patients ◽  
Double Blind ◽  
Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

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