Docosahexaenoic acid (DHA) in infant formula at concentrations based on worldwide human milk has resulted in circulating red blood cell (RBC) lipids related to visual and cognitive development. In this study, infants received study formula (17mg DHA/100kcal) with a commercially-available (Control: n=140; DHASCO®) or alternative (DHASCO®-B: n=127) DHA single cell oil from 14 to 120 days of age. No significant group differences were detected for growth rates by gender through 120 days of age. Blood fatty acids at 120 days of age were assessed by capillary column gas chromatography in a participant subset (Control: n=34; DHASCO-B: n=27). The 90% confidence interval (91-104%) for the group mean (geometric) total RBC DHA (µg/mL) ratio fell within the pre-specified equivalence limit (80-125%), establishing study formula equivalence with respect to DHA. This study demonstrated infant formula with DHASCO-B was safe, well-tolerated, and associated with normal growth. Furthermore, DHASCO and DHASCO-B represented equivalent sources of DHA as measured by circulating RBC DHA.
Objectives To evaluate the impact of a dietary supplement within an elderly population who reside in a Community Living Center (CLC; VA Nursing Home), on the number of respiratory tract infections (RTIs) during a 90-day study period. Methods This is a randomized, double-blind, placebo-controlled study to evaluate the impact of bovine Lactoferrin (bLf) on RTIs in an elderly nursing home population in the US. Subjects will be residents of the CLC and screened within 21 days prior to starting study supplementation. Eligible participants were at least 55 years of age, able to eat and drink and expected to reside at the CLC for the duration of the study. Consent was obtained from the study participant or their legally recognized representative decision maker. Participants will be excluded if: receiving tube feeds or specialized diets for eating disorders; immunocompromised; have a life expectancy of less than six months; or allergic to study products. Results Subjects will be randomized in a ratio of 1:1 to either investigational (600 mg of bLf) or (placebo arms. All participants will take study supplement by mouth daily for 90 days. Subjects will be assessed daily for RTI symptoms. Blood and saliva will be collected at 45 and 90 days. Ad hoc assessments and a nasal sample will take place if a subject develops a protocol-defined RTI. Conclusions The primary outcome will be number of RTIs over the 90-day study period. Secondary outcomes include severity and duration of RTI symptoms, symptoms associated with RTIs, number of RTI complications, and nasopharyngeal swab at onset of RTI, Other secondary outcomes include the following, all measured at baseline, day 45 and day 90: quality of life by questionnaire, weight, saliva markers, laboratory testing and immunological markers. An exploratory endpoint is vaccine specific inflammatory panel (influenza and Sars-Cov2) measured upon vaccination during supplement period. RTI number, severity, duration and complications and medically confirmed adverse events will be compared between the placebo and investigational groups. Funding Sources RB/Mead Johnson & Company.
BackgroundPre‐ and probiotics beneficially affect the host by improving the survival and establishment of live microbes from dietary sources in the gastrointestinal tract. We have previously demonstrated adequate growth in healthy term infants receiving a routine cow's milk‐based formula supplemented with a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS), or the probiotic Lactobacillus rhamnosus GG (LGG) added to partially or extensively hydrolyzed formulas.ObjectiveThe objective of the current study was to establish that an investigational study formula containing both pre‐ and probiotics provides adequate growth compared to the currently marketed formula.MethodsIn this multi‐center, double blind, controlled, parallel‐group, prospective study, infants received one of two formulas from 14‐120 days of age: marketed, routine infant formula with PDX/GOS (1:1 ratio, 4g/L) (Control, n=171), or a similar, investigational formula supplemented with PDX/GOS and LGG (1x106 CFU/g powder) (LGG, n=177). The primary outcome for this study was growth rate from 14 to 120 days. Growth rates from 14 to 30, 60, 90, and 120 days of age were analyzed by gender using ANOVA.ResultsThere were no differences between groups in infant demographic or anthropometric characteristics at birth and there was no difference in study completion rate. There were no statistical differences detected in the rate of weight gain (g/day) from 14 to 120 days of age for male (Control, 31.3 ± 0.7; LGG, 31.6 ± 0.6) or female (Control, 27.3 ± 0.7; LGG, 25.7 ± 0.7) infants.ConclusionsResults of this study demonstrated that the investigational formula supplemented with PDX and LGG was associated with normal growth when fed to healthy term infants from 14 to 120 days of age.
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