Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety

Background/Objectives  

Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification.     

Controlled,double-blind,randomized clinical trial to evaluate the impact of fruit juice consumption on the evolution of infants with acute diarrhea

In order to assess the effects of juice feedings during acute diarrhea a double-blind, randomized study was performed in 90 children, mean age of 10 ± 4.28 months. Thirty patients with acute diarrhea were fed twice-daily 15 ml/kg of Apple Juice (AJ), 30 received White Grape Juice (WGJ), and 30 were given colored and flavored water (WA) as part of their age appropriate dietary intake. The duration and severity of diarrhea were the main endpoint variables of the study performed in a metabolic unit. The patients were similar among the 3 groups, had diarrhea for 50–64 hours prior to admission, and were dehydrated when admitted to the unit for study. Half of the patients in each group were well nourished and the others had mild to moderate degrees of malnutrition. Rotavirus infection was the agent causing the illness in 63% of the patients. The infants fed juice ingested 14–17% more calories than those given WA, (those receiving AJ and WGJ ingested 95 and 98 Calories/Kg/d respectively) whereas those receiving WA consumed 81 cal/kg/d). The increased energy intake was not at the expense of other foods or milk formula. The mean body weight gain was greater among patients receiving WGJ (+ 50.7 gm) as compared with the patients in the AJ group (+ 18.3 gm) or the patients fed WA (- 0.7 gm) (p = 0.08). The duration of the illness was longer in the infants fed juice as compared with those given WA (p = 0.006), the mean +/- SD duration in hours was 49.4 ± 32.6, 47.5 ± 38.9 and 26.5 ± 27.4 in patients fed AJ, WGJ and WA respectively. All patients improved while ingesting juice and none of them developed persistent diarrhea; most recovered within 50 hours of the beginning of treatment and less than one fourth had diarrhea longer than 96 hours in the unit. The fecal losses were also increased among the juice fed patients (p = 0.001); the mean ± SD fecal excretion in g/kg/h was 3.94 ± 2.35, 3.59 ± 2.35, and 2.19 ± 1.63 in AJ, WGJ and WA respectively. The stool output was highest during the first day of treatment among all the patients, though those fed AJ had the highest volume of fecal losses and those who received WA had the lowest stool excretion. After the first day of treatment the differences in fecal excretion were not significant. The ability to tolerate carbohydrates during the illness and immediately after recovery was similar among the 3 groups of patients. Intake of juices with different fructose/glucose ratios and osmolarities resulted in more fecal losses and more prolonged diarrhea as compared with water feedings, but the patients given juice ingested more calories and gained more weight, particularly among those being fed the juice with equimolar concentrations of fructose and glucose.     

Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants

Background  

Parents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional. Up to one-half of formula-fed infants experience a formula change during the first six months of life.     

Probiotics, prebiotics infant formula use in preterm or low birth weight infants: a systematic review

Malnutrition is a significant factor in predicting cancer patients?? quality of life (QoL). We systematically reviewed the literature on the role of nutritional status in predicting QoL in cancer. We searched MEDLINE database using the terms ??nutritional status?? in combination with ??quality of life?? together with ??cancer??. Human studies published in English, having nutritional status as one of the predictor variables, and QoL as one of the outcome measures were included. Of the 26 included studies, 6 investigated head and neck cancer, 8 gastrointestinal, 1 lung, 1 gynecologic and 10 heterogeneous cancers. 24 studies concluded that better nutritional status was associated with better QoL, 1 study showed that better nutritional status was associated with better QoL only in high-risk patients, while 1 study concluded that there was no association between nutritional status and QoL. Nutritional status is a strong predictor of QoL in cancer patients. We recommend that more providers implement the American Society of Parenteral and Enteral Nutrition (ASPEN) guidelines for oncology patients, which includes nutritional screening, nutritional assessment and intervention as appropriate. Correcting malnutrition may improve QoL in cancer patients, an important outcome of interest to cancer patients, their caregivers, and families.     

Probiotics, prebiotics infant formula use in preterm or low birth weight infants: a systematic review

ABSTRACT: BACKGROUND: Previous reviews (2005 to 2009) on preterm infants given probiotics or prebiotics with breast milk or mixed feeds focused on prevention of Necrotizing Enterocolitis, sepsis and diarrhea. This review assessed if probiotics, prebiotics led to improved growth and clinical outcomes in formula fed preterm infants. METHODS: Cochrane methodology was followed using randomized controlled trials (RCTs) which compared preterm formula containing probiotic(s) or prebiotic(s) to conventional preterm formula in preterm infants. The mean difference (MD) and corresponding 95% confidence intervals (CI) were reported for continuous outcomes, risk ratio (RR) and corresponding 95% CI for dichotomous outcomes. Heterogeneity was assessed by visual inspection of forest plots and a chi2 test. An I2 test assessed inconsistencies across studies. I2> 50% represented substantial heterogeneity. RESULTS: Four probiotics studies (N=212), 4 prebiotics studies (N=126) were included. Probiotics: There were no significant differences in weight gain (MD 1.96, 95% CI: -2.64 to 6.56, 2 studies, n=34) or in maximal enteral feed (MD 35.20, 95% CI: -7.61 to 78.02, 2 studies, n=34), number of stools per day increased significantly in probiotic group (MD 1.60, 95% CI: 1.20 to 2.00, 1 study, n=20). Prebiotics: Galacto-oligosaccharide / Fructo-oligosaccharide (GOS/FOS) yielded no significant difference in weight gain (MD 0.04, 95% CI: -2.65 to 2.73, 2 studies, n=50), GOS/FOS yielded no significant differences in length gain (MD 0.01, 95% CI: -0.03 to 0.04, 2 studies, n=50). There were no significant differences in head growth (MD [MINUS SIGN]0.01, 95% CI: -0.02 to 0.00, 2 studies, n=76) or age at full enteral feed (MD [MINUS SIGN]0.79, 95% CI: -2.20 to 0.61, 2 studies, n=86). Stool frequency increased significantly in prebiotic group (MD 0.80, 95% CI: 0.48 to 1.1, 2 studies, n=86). GOS/FOS and FOS yielded higher bifidobacteria counts in prebiotics group (MD 2.10, 95% CI: 0.96 to 3.24, n=27) and (MD 0.48, 95% CI: 0.28 to 0.68, n=56). CONCLUSIONS: There is not enough evidence to state that supplementation with probiotics or prebiotics results in improved growth and clinical outcomes in exclusively formula fed preterm infants.     

Onset of the Thermic Effect of Feeding (TEF): a randomized cross-over trial

Background  

The purpose of this investigation was to identify the onset of the thermic effect of feeding (TEF) after ingestion of a high carbohydrate (CHO) and a high protein (PRO) 1255 kJ (300 kcal) drink.     

Modification of stool's water content in constipated infants: management with an adapted infant formula

Background

There is increasing global acceptance that viscous soluble fibers lower serum LDL cholesterol (LDL-C), but most evidence for this comes from studies in Caucasians. To see if oat β-glucan lowers LDL-C in Caucasians and non-Caucasians we conducted a post-hoc analysis of the results of a randomized, controlled, double-blind, multi-center clinical trial whose primary aim was to determine if molecular-weight (MW) influenced the LDL-C-lowering effect of oat β-glucan.

Results

Caucasian and non-Caucasian subjects with LDL-C-C ≥ 3.0 and ≤ 5.0 mmol/L (n = 786 screened, n = 400 ineligible, n = 19 refused, n = 367 randomized, n = 345 completed, n = 1 excluded for missing ethnicity) were randomly assigned to consume cereal containing wheat-fiber (Control, n = 74:13 Caucasian:non-Caucasian) or 3 g high-MW (3H, 2,250,000 g/mol, n = 67:19), 4 g medium-MW (4 M, 850,000 g/mol, n = 50:17), 3 g medium-MW (3M, 530,000 g/mol, n = 54:9) or 4 g low-MW (4 L, 210,000 g/mol, n = 51:12) oat β-glucan daily for 4 weeks. LDL-C after 4 weeks was influenced by baseline LDL-C (p < 0.001) and treatment (p = 0.003), but not ethnicity (p = 0.74). In all subjects, compared to control, 3 H, 4 M and 3 M reduced LDL-C significantly by 4.8 to 6.5%, but 4 L had no effect. Compared to control, the bioactive oat β-glucan treatments (3H, 4M and 3M) reduced LDL-C by a combined mean (95% CI) of 0.18 (0.06, 0.31) mmol/L (4.8%, n = 171, p = 0.004) in Caucasians, a value not significantly different from the 0.37 (0.09, 0.65) mmol/L (10.3%, n = 45, p = 0.008) reduction in non-Caucasians.

Conclusion

We conclude that oat β-glucan reduces LDL-C in both Caucasians and non-Caucasians; there was insufficient power to determine if the magnitude of LDL-C-lowering differed by ethnicity.

Trial Registration

ClinicalTrials.gov: NCT00981981     

Erythrocyte fatty acids of term infants fed either breast milk,standard formula,or formula supplemented with long-chain polyunsaturates

The purpose of our study was to assess whether a supplement of fish oil (FO) and evening primrose oil (EPO) for formula-fed infants was capable of avoiding reductions in erythrocyte docosahexaenoic acid (DHA, 22∶6n−3) and arachidonic acid (AA, 20∶4n−6) associated with standard formula feeding. Healthy, term infants, whose mothers chose to formula feed, were randomized to either a placebo or supplemented formula for their first 30 wk of life. A reference group of beast-fed infants also was enrolled. Erythrocyte fatty acids were measured by capillary gas chromatography on day 5 and in weeks 6, 16, and 30. Supplementation of formula with 0.36% of total fatty acids as DHA resulted in erythrocyte DHA being maintained at or above breast-fed levels for the entire 30-wk study period, and breast feeding (0.21% DHA) resulted in a modest fall in erythrocyte DHA relative to baseline (day 5) values. The level of erythrocyte DHA in placebo formula-fed infants was halved by week 16. AA levels decreased in all infants in the first six weeks, but the levels in breast- and placebo formula-fed infants increased with age and returned to approximate baseline (day 5) values by 16 and 30 wk of age, respectively. Erythrocyte AA in FO+EPO-supplemented infants remained low and below breast- and placebo formula-fed levels. Our data suggest that dietary supplementation with DHA at 0.36% total fatty acids results in erythrocyte DHA levels above those found in breast-fed infants. EPO supplementation was not effective at maintaining erythrocyte AA when given with FO.     

Efficacy of a nootropic spearmint extract on reactive agility: a randomized,double-blind,placebo-controlled,parallel trial

Background

Proprietary spearmint extract (PSE) containing a minimum 14.5% rosmarinic acid and 24% total phenolic content, has evinced positive effects on cognition in individuals aged 50–70 with memory impairment after chronic supplementation. To address the growing interest in connecting mental and physical performance, the present study examined whether the nootropic effects of PSE translate into changes in reactive agility following daily supplementation with PSE.

Methods

Utilizing a randomized, double-blind, placebo-controlled, parallel design, healthy, recreationally-active men and women (n?=?142) received 900?mg of PSE or placebo (PLA) daily for 90?days. Reactive agility, our primary outcome, was determined by measuring the number of hits and average reaction time (ART) on a Makoto Arena II, a 360⁰ audio-visual device that measures stationary, lateral, and multi-directional active choice reaction performance. Safety was evaluated using complete blood count, comprehensive metabolic panel, and blood lipids. Measurements were evaluated on days 7, 30, and 90 of supplementation.

Results

An overall treatment effect (p?=?0.019) was evident for increased hits with PSE on the stationary test with footplates, with between group differences at Day 30 (PSE vs. PLA: 28.96?±?2.08 vs. 28.09?±?1.92 hits; p?=?0.040) and Day 90 (PSE vs. PLA: 28.42?±?2.54 vs. 27.02?±?3.55 hits; p?=?0.002). On the same task, ART improved (treatment effect, p?=?0.036) with PSE at Day 7 (PSE vs. PLA: 0.5896?±?0.060 vs. 0.6141?±?0.073?s; p?=?0.049) and Day 30 (PSE vs. PLA: 0.5811?±?0.068 vs. 0.6033?±?0.055?s; p?=?0.049). PSE also significantly increased hits (treatment effect, p?=?0.020) at Day 30 (PSE vs. PLA: 19.25?±?1.84 vs. 18.45?±?1.48 hits; p?=?0.007) and Day 90 (PSE vs. PLA: 19.39?±?1.90 vs. 18.66?±?1.64 hits; p?=?0.026) for the multi-directional test with footplates. Significant differences were not observed in the remaining Makoto tests. PSE was well tolerated as evidenced by no effects observed in the blood safety panels.

Conclusions

The findings of the current study demonstrate that consumption of 900?mg of PSE improved specific measures of reactive agility in a young, active population.

Trial registration

clinicaltrials.gov, NCT02518165. Registered August 7, 2015 – retrospectively registered.

     

Effects of carbohydrates-BCAAs-caffeine ingestion on performance and neuromuscular function during a 2-h treadmill run: a randomized, double-blind, cross-over placebo-controlled study

Background

Carbohydrates (CHOs), branched-chain amino acids (BCAAs) and caffeine are known to improve running performance. However, no information is available on the effects of a combination of these ingredients on performance and neuromuscular function during running.

Methods

The present study was designed as a randomized double-blind cross-over placebo-controlled trial. Thirteen trained adult males completed two protocols, each including two conditions: placebo (PLA) and Sports Drink (SPD: CHOs 68.6 g.L^-1, BCAAs 4 g.L^-1, caffeine 75 mg.L^-1). Protocol 1 consisted of an all-out 2 h treadmill run. Total distance run and glycemia were measured. In protocol 2, subjects exercised for 2 h at 95% of their lowest average speeds recorded during protocol 1 (whatever the condition). Glycemia, blood lactate concentration and neuromuscular function were determined immediately before and after exercise. Oxygen consumption ( ), heart rate (HR) and rate of perceived exertion (RPE) were recorded during the exercise. Total fluids ingested were 2 L whatever the protocols and conditions.

Results

Compared to PLA, ingestion of SPD increased running performance (p = 0.01), maintained glycemia and attenuated central fatigue (p = 0.04), an index of peripheral fatigue (p = 0.04) and RPE (p = 0.006). Maximal voluntary contraction, , and HR did not differ between the two conditions.

Conclusions

This study showed that ingestion of a combination of CHOs, BCAAs and caffeine increased performance by about 2% during a 2-h treadmill run. The results of neuromuscular function were contrasted: no clear cut effects of SPD were observed.

Trial registration

ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT00799630     

Gemcadiol: A new antilipemic drug,a clinical trial

Nineteen patients with Type II, III, IV, or V hyperlipoproteinemia received gemcadiol (2,2,9,9,-tetramethyl-1,10-decanediol) in daily doses between 1.2 and 2 g. The patients were hospitalized for dose titration and then followed as outpatients on appropriate doses of gemcadiol. In Type II hyperlipoproteinemia, serum cholesterol was lowered by an average of 24%. The serum triglycerides in Type IV hyperlipoproteinemia decreased by an average of 51%. Serum uric acid was not altered. There were no changes of subjective feelings or of clinical or laboratory findings, including creatine phosphokinase. This study indicates that gemcadiol is an effective antilipemic agent that is very well tolerated.     

Intravenous Vitamin C administration reduces fatigue in office workers: a double-blind randomized controlled trial

Background  

Studies of the efficacy of vitamin C treatment for fatigue have yielded inconsistent results. One of the reasons for this inconsistency could be the difference in delivery routes. Therefore, we planned a clinical trial with intravenous vitamin C administration.     

Efficacy of different strategies to treat anemia in children: a randomized clinical trial

Background  

Anemia continues to be a major public health problem among children in many regions of the world, and it is still not clear which strategy to treat it is most effective.     

Nutritional balance studies: evaluation of a premature infant formula

A 24 kcal/oz (81 kcal/100 ml) premature infant formula (Enfamil Premature Formula) with moderately high mineral content (117 mg Ca/100 ml and 58 mg P/100 ml) and a protein content of 3 g/100 kcal was evaluated in sixteen 3-day balance studies at 10 and 21 days of age in nine premature infants with birth weights from 1,200 to 1,400 g. Growth rates were similar to in utero rates, and the formula was well accepted and tolerated. Calcium retention (62.5%) was similar to in utero accretion, and phosphorus retention was only slightly lower. Nitrogen retention was high without the development of metabolic acidosis or abnormal serum urea nitrogen levels.     

Randomized trials with polyunsaturated fatty acid interventions in preterm and term infants: Functional and clinical outcomes

The role of polyunsaturated fatty acids (PUFA) in infant nutrition has now been well studied through many randomized controlled trials (RCT) that provide us with high-quality evidence, particularly in relation to efficacy. As a result of a systematic search of the literature for RCT of supplementation of formulas of term and preterm infants with long-chain polyunsaturated fatty acids (LC-PUFA), we have identified 21 studies that have physiological responses or growth as outcomes. There have been 11 RCT involving preterm infants, and many of these claim a beneficial effect on visual, neural, or developmental outcomes. There are some reports of negative effects on growth in relation to the addition of n−3 LC-PUFA to preterm formulas but not when AA is added with n−3 LC-PUFA. Small studies have shown no differences in prostanoid formation or peroxidative stress between n−3 IC-PUFA-supplemented and unsupplemented infants. There have been 10 RCT involving term infants; whereas some studies report an effect on visual/neural/developmental outcomes, an equal number report no effect. There have been no reports of negative effects of n−3 LC-PUFA on growth in term infants. In summary, there appear to be few safety concerns relating to the use of LC-PUFA in infant nutrition. The potential medium- and long-term effects of including these compounds in the early diet of infants remain to be assessed.     

Chronic and acute effects of walnuts on antioxidant capacity and nutritional status in humans: a randomized,cross-over pilot study

Background  

Compared with other common plant foods, walnuts (Juglans regia) are consistently ranked among the highest in antioxidant capacity. In vitro, walnut polyphenols inhibit plasma and LDL oxidation, while in animal models they lower biomarkers of oxidative stress and raise antioxidant capacity. A limited number of human feeding trials indicate that walnuts improve some measures of antioxidant status, but not others.     

The effects of facemasks on airway inflammation and endothelial dysfunction in healthy young adults: a double-blind,randomized, controlled crossover study

Background

Facemasks are increasingly worn during air pollution episodes in China, but their protective effects are poorly understood. We aimed to evaluate the filtration efficiencies of N95 facemasks and the cardiopulmonary benefits associated with wearing facemasks during episodes of pollution.

Results

We measured the filtration efficiencies of particles in ambient air of six types of N95 facemasks with a manikin headform. The most effective one was used in a double-blind, randomized, controlled crossover study, involving 15 healthy young adults, conducted during 2 days of severe pollution in Beijing, China. Subjects were asked to walk along a busy-traffic road for 2 h wearing authentic or sham N95 facemasks. Clinical tests were performed four times to determine changes in the levels of biomarkers of airway inflammation, endothelial dysfunction, and oxidative stress within 24 h after exposure.The facemasks removed 48–75% of number concentrations of ambient air particles between 5.6 and 560 nm in diameter. After adjustments for multiple comparison, the exhaled nitric oxide level and the levels of interleukin-1α, interleukin-1β, and interleukin-6 in exhaled breath condensate increased significantly in all subjects; however, the increases in those wearing authentic facemasks were statistically significantly lower than in the sham group. No significant between-group difference was evident in the urinary creatinine-corrected malondialdehyde level. In arterial stiffness indicators, the ejection duration of subjects wearing authentic facemasks was higher after exposure compared to the sham group; no significant between-group difference was found in augmentation pressure or the augmentation index.

Conclusions

In young healthy adults, N95 facemasks partially reduced acute particle-associated airway inflammation, but neither systemic oxidative stress nor endothelial dysfunction improved significantly. The clinical significance of these findings long-term remains to be determined.

Trial registration

The trial registration number (TRN) for this study is ChiCTR1800016099, which was retrospectively registered on May 11, 2018.

     

Weight, physical activity and dietary behavior change in young mothers: short term results of the HeLP-her cluster randomized controlled trial

Background  

Preventing weight gain rather than treating established obesity is an important economic and public health response to the rapidly increasing rates of obesity worldwide. Treatment of established obesity is complex and costly requiring multiple resources. Preventing weight gain potentially requires fewer resources to reach broad population groups, yet there is little evidence for successful interventions to prevent weight gain in the community. Women with children are an important target group because of high rates of weight gain and the potential to influence the health behaviors in family members.