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

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.

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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

Clinical Medicine Insights Pediatrics ◽

10.4137/cmped.s17841 ◽

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.

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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 ◽

10.3390/nu12072072 ◽

2020 ◽

Vol 12 (7) ◽

pp. 2072 ◽

Cited By ~ 1

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.

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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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A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

Scientific Reports ◽

10.1038/s41598-021-92242-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Lara Bücker ◽

Josefine Gehlenborg ◽

Steffen Moritz ◽

Stefan Westermann

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Primary Outcome ◽

Controlled Trial ◽

Group Differences ◽

Control Group ◽

Gambling Problems ◽

Randomized Controlled ◽

Secondary Outcomes ◽

Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

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Term infant formula supplemented with milk-derived oligosaccharides shifts the gut microbiota closer to that of human milk-fed infants and improves intestinal immune defense: A randomized controlled trial

American Journal of Clinical Nutrition ◽

10.1093/ajcn/nqab336 ◽

2021 ◽

Author(s):

Elvira Estorninos ◽

Rachel B Lawenko ◽

Eisel Palestroque ◽

Norbert Sprenger ◽

Jalil Benyacoub ◽

...

Keyword(s):

Immune Response ◽

Randomized Controlled Trial ◽

Gut Microbiota ◽

Human Milk ◽

Infant Formula ◽

Controlled Trial ◽

Immune Defense ◽

Intact Protein ◽

Phylogenetic Distance ◽

Randomized Controlled

Abstract Background Bovine milk-derived oligosaccharides (MOS) containing primarily galacto-oligosaccharides with inherent levels of sialylated oligosaccharides can be added to infant formula to enhance the oligosaccharide profile. Objective To investigate the effects of a MOS-supplemented infant formula on gut microbiota and intestinal immunity. Methods In a double-blind, randomized, controlled trial, healthy-term formula-fed infants aged 21–26 days either received an intact protein cow's milk-based formula (control group, CG, n = 112) or the same formula containing 7.2 g MOS/L (experimental group, EG, n = 114) until age 6 months. Exclusively human milk-fed infants (HFI, n = 70) from an observational study served as reference. Fecal samples collected at baseline, 2.5 and 4 months of age were assessed for microbiota (16S ribosomal ribonucleic acid—based approaches), metabolites and biomarkers of gut health and immune response. Results At age 2.5 and 4 months, redundancy analysis (P = 0.002) and average phylogenetic distance (P < 0.05) showed that the overall microbiota composition in EG was different from CG and closer to that of HFI. Similarly, EG caesarean-born infants were different from CG caesarean- or vaginally-born infants and approaching HFI vaginally-born infants. Relative bifidobacteria abundance was higher in EG vs. CG (P < 0.05) approaching HFI. At age 4 months, counts of Clostridioides difficile and Clostridium perfringens were ∼90% (P < 0.001) and ∼65% (P < 0.01) lower in EG vs. CG, respectively. Mean (95%CI) fecal secretory immunoglobulin A (IgA) in EG was twice that of CG [70 (57,85) vs. 34 (28,42) mg/g, P < 0.001] and closer to HFI. Fecal oral polio vaccine-specific IgA was ∼50% higher in EG vs. CG (P = 0.065). Compared to CG, EG and HFI had lower fecal calcium excretion (by ∼30%) and fecal pH (P < 0.001), and higher lactate concentration (P < 0.001). Conclusions Infant formula with MOS shifts the gut microbiota and metabolic signature closer to that of HFI, has a strong bifidogenic effect, reduces fecal pathogens, and improves intestinal immune response.

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Testing the Effects of the Shamiri Intervention and its Components on Anxiety, Depression, Wellbeing, and Academic Functioning in Kenyan Adolescents: Study Protocol for a Five-Arm Randomized Controlled Trial

10.31234/osf.io/6xdka ◽

2021 ◽

Author(s):

Katherine E. Venturo-Conerly ◽

Tom L Osborn ◽

Akash R Wasil ◽

Huong Le ◽

Emily Corrigan ◽

...

Keyword(s):

Mental Health ◽

Academic Performance ◽

Controlled Trial ◽

Growth Mindset ◽

Anxiety Symptoms ◽

Control Group ◽

Randomized Controlled ◽

Multi Level ◽

Secondary Outcomes ◽

Over Time

Background: Treatments for youth mental disorders are a public health priority, especially in sub-Saharan Africa (SSA), where treatment options remain limited due to high cost, elevated stigma, and lack of trained mental health professionals. Brief, accessible, and non-stigmatizing community-based interventions delivered by lay-providers may help address treatment needs in SSA. One such intervention, the Shamiri Intervention, consisting of three elements (growth mindset, gratitude, and value affirmation) has been tested in randomized controlled trials with school-going Kenyan adolescents. This three-element Shamiri Intervention has been shown to significantly reduce depression and anxiety symptoms and improve social support and academic performance relative to a control group. In this trial, we aim to investigate the effects of each element of the Shamiri Intervention.Methods: In this five-arm randomized controlled trial, we will test each of the intervention components (growth mindset, gratitude, and value affirmation) against the full Shamiri Intervention and against a study-skills control intervention. Students (Nplanned=1288) at participating secondary schools who are interested in participating in this universal intervention will be randomized in equal numbers into the five groups. The students will meet in groups of 8-15 students led by local high school graduate lay-providers. These lay-providers will receive 10 hours of training, plus expert supervision once a week throughout the intervention delivery. Multi-level models will be used to compare trajectories over time of the primary outcomes (depressive symptoms, anxiety symptoms, academic performance, and wellness) and secondary outcomes in each intervention group to the control group. Multi-level models will also be used to compare trajectories over time of the primary outcomes (depressive symptoms, anxiety symptoms, academic performance, and wellness) and secondary outcomes of those in the single-element interventions compared to the full Shamiri Intervention. Finally, effect sizes (calculated as mean gain scores) will be used to compare all groups on all measures. Discussion: This trial will shed light on the mechanisms and outcomes targeted by each individual intervention, helping prioritize which mental health interventions are most important to disseminate.

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

Nutrients ◽

10.3390/nu11071530 ◽

2019 ◽

Vol 11 (7) ◽

pp. 1530 ◽

Cited By ~ 2

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.

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Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.14338 ◽

2019 ◽

Author(s):

Simon Driver ◽

Chad Swank ◽

Katherine Froehlich-Grobe ◽

Evan McShan ◽

Stephanie Calhoun ◽

...

Keyword(s):

Weight Loss ◽

Randomized Controlled Trial ◽

Weight Gain ◽

Emotional Disorders ◽

Cerebrovascular Accident ◽

Recurrent Stroke ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled

BACKGROUND Weight gain can be a consequence of stroke, or cerebrovascular accident (CVA), because of impaired mobility, behavioral and emotional disorders, and sensory losses. Weight gain increases the patient’s risk of recurrent stroke and chronic diseases, such as diabetes, metabolic syndrome, and pulmonary and heart disease. Approaches to weight loss in this population are lacking, although necessary because of the unique physiological and cognitive needs of persons after a stroke. Evidence shows that intensive behavioral therapy interventions that address both physical activity and diet offer the greatest potential for weight loss. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight loss program that has been used extensively with the general population; this program was modified to meet the needs of people who have had a stroke (GLB-CVA). OBJECTIVE This randomized controlled trial (RCT) aims to examine the efficacy of the GLB-CVA on weight and secondary outcomes, compared with that of a waitlist control group. METHODS This RCT will enroll and randomize 64 patients over an 18-month period. RESULTS Currently, 51 people are waitlisted, with 23 out of 51 screened and 16 out of 23 eligible. CONCLUSIONS It is anticipated that the findings from this RCT will contribute to the evidence base regarding weight loss strategies for people living with stroke. CLINICALTRIAL ClinicalTrials.gov NCT03873467; https://clinicaltrials.gov/ct2/show/NCT03873467. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14338

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Efficacy of a transdiagnostic cognitive-behavioral intervention for eating disorder psychopathology delivered through a smartphone app: a randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291720003426 ◽

2020 ◽

pp. 1-12 ◽

Cited By ~ 1

Author(s):

Jake Linardon ◽

Adrian Shatte ◽

John Rosato ◽

Matthew Fuller-Tyszkiewicz

Keyword(s):

Randomized Controlled Trial ◽

Eating Disorder ◽

Binge Eating ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Smartphone App ◽

Control Group ◽

Randomized Controlled ◽

Post Test ◽

Secondary Outcomes

Abstract Background Although effective treatments exist for diagnostic and subthreshold-level eating disorders (EDs), a significant proportion of affected individuals do not receive help. Interventions translated for delivery through smartphone apps may be one solution towards reducing this treatment gap. However, evidence for the efficacy of smartphones apps for EDs is lacking. We developed a smartphone app based on the principles and techniques of transdiagnostic cognitive-behavioral therapy for EDs and evaluated it through a pre-registered randomized controlled trial. Methods Symptomatic individuals (those who reported the presence of binge eating) were randomly assigned to the app (n = 197) or waiting list (n = 195). Of the total sample, 42 and 31% exhibited diagnostic-level bulimia nervosa and binge-eating disorder symptoms, respectively. Assessments took place at baseline, 4 weeks, and 8 weeks post-randomization. Analyses were intention-to-treat. The primary outcome was global levels of ED psychopathology. Secondary outcomes were other ED symptoms, impairment, and distress. Results Intervention participants reported greater reductions in global ED psychopathology than the control group at post-test (d = −0.80). Significant effects were also observed for secondary outcomes (d's = −0.30 to −0.74), except compensatory behavior frequency. Symptom levels remained stable at follow-up. Participants were largely satisfied with the app, although the overall post-test attrition rate was 35%. Conclusion Findings highlight the potential for this app to serve as a cost-effective and easily accessible intervention for those who cannot receive standard treatment. The capacity for apps to be flexibly integrated within current models of mental health care delivery may prove vital for addressing the unmet needs of people with EDs.

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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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