scholarly journals Long-term effects of a modified, low-protein infant formula on growth and body composition: Follow-up of a randomized, double-blind, equivalence trial

2021 ◽  
Author(s):  
Stefanie M.P. Kouwenhoven ◽  
Nadja Antl ◽  
Martijn J.J. Finken ◽  
Jos W.R. Twisk ◽  
Eline M. van der Beek ◽  
...  
Keyword(s):  
Body Composition ◽  
Infant Formula ◽  
Long Term Effects ◽  
Double Blind ◽  
Equivalence Trial ◽  
Low Protein

scholarly journals A modified low-protein infant formula supports adequate growth in healthy, term infants: a randomized, double-blind, equivalence trial

2019 ◽  
Vol 111 (5) ◽  
pp. 962-974 ◽  
Author(s):  
Stefanie M P Kouwenhoven ◽  
Nadja Antl ◽  
Martijn J J Finken ◽  
Jos W R Twisk ◽  
Eline M van der Beek ◽  
...  
Keyword(s):  
Body Composition ◽  
Weight Gain ◽  
Amino Acid ◽  
Infant Formula ◽  
Protein Intake ◽  
Amino Acid Profile ◽  
Double Blind ◽  
Equivalence Trial ◽  
Low Protein ◽  
Formula Group

ABSTRACT Background A high protein intake in early life is associated with a risk of obesity later in life. The essential amino acid requirements of formula-fed infants have been reassessed recently, enabling a reduction in total protein content and thus in protein intake. Objectives We aimed to assess the safety of an infant formula with a modified amino acid profile and a modified low-protein (mLP) content in healthy term-born infants. Outcomes were compared with a specifically designed control (CTRL) infant formula. Methods In this double-blind, randomized controlled equivalence trial, infants received either mLP (1.7 g protein/100 kcal; n = 90) or CTRL formula (2.1 g protein/100 kcal; n = 88) from enrollment (age ≤ 45 d) to 6 mo of age. A breastfed group served as a reference (n = 67). Anthropometry and body composition were determined at baseline, 17 wk (including safety blood parameters), and 6 mo of age. The primary outcome was daily weight gain from enrollment up until the age of 17 wk (at an equivalence margin of ±3.0 g/d). Results Weight gain from baseline (mean ± SD age: 31 ± 9 d) up to the age of 17 wk was equivalent between the mLP and CTRL formula groups (27.9 and 28.8 g/d, respectively; difference: −0.86 g/d; 90% CI: −2.36, 0.63 g/d). No differences in other growth parameters, body composition, or in adverse events were observed. Urea was significantly lower in the mLP formula group than in the CTRL formula group (−0.74 mmol/L; 95% CI: −0.97, −0.51 mmol/L; P < 0.001). Growth rates, fat mass, fat-free mass, and several essential amino acids were significantly higher in both formula groups than in the breastfed reference group. Conclusions Feeding an infant formula with a modified amino acid profile and a lower protein content from an average age of 1 mo until the age of 6 mo is safe and supports an adequate growth, similar to that of infants consuming CTRL formula. This trial was registered at www.trialregister.nl as Trial NL4677.

The long-term effects of homeopathic treatment of chronic headaches: one year follow-up and single case time series analysis

2001 ◽  
Vol 90 (02) ◽  
pp. 63-72 ◽  
Author(s):  
H Walach ◽  
T Lowes ◽  
D Mussbach ◽  
U Schamell ◽  
W Springer ◽  
...  
Keyword(s):  
Time Series ◽  
Single Case ◽  
Double Blind Study ◽  
Long Term Effects ◽  
Double Blind ◽  
Homeopathic Treatment ◽  
Chronic Headaches ◽  
One Year

AbstractLittle is known about long-term effects of homeopathic treatment. Following a double-blind, placebo controlled trial of classical homeopathy in chronic headaches, we conducted a 1-year observational study of 18 patients following the double-blind phase, and a complete follow-up study of all trial participants. Eighteen patients received free treatment for daily diary data (frequency, intensity, duration of headaches) over the course of 1 y. All patients enrolled in the double-blind study were sent a 6-week headache diary, a follow-up questionnaire, a personality inventory and a complaint list. Eighty-seven, of the original 98 patients enrolled returned questionnaires, 81 returned diaries. There was no additional change from the end of the trial to the one-year follow-up. The improvement seen at the end of the 12-week trial was stable after 1 y. No differential effects according to treatment after the trial could be seen. Patients with no treatment following the trial had the most improvement after 1 y. Five of 18 patients can be counted responders according to ARIMA analysis of single-case time-series. Patients with double diagnoses and longer treatment duration tended to have clearer improvements than the rest of the patients. Approximately 30% of patients in homeopathic treatment will benefit after 1 y of treatment. There is no indication of a specific, or of a delayed effect of homeopathy.

scholarly journals The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation

2019 ◽  
Vol 109 (5) ◽  
pp. 1380-1392 ◽  
Author(s):  
John Colombo ◽  
D Jill Shaddy ◽  
Kathleen Gustafson ◽  
Byron J Gajewski ◽  
Jocelynn M Thodosoff ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Preterm Birth ◽  
Visual Attention ◽  
Maternal Blood ◽  
Chain Polyunsaturated Fatty Acid ◽  
Long Term Effects ◽  
Double Blind ◽  
Early Preterm Birth

ABSTRACT Background Docosahexaenoic acid (DHA) is a long-chain polyunsaturated fatty acid that has been linked to improved vision and cognition in postnatal feeding studies and has been consistently associated with reduction of early preterm birth in prenatal supplementation trials. This is a report of the first long-term follow-up of infants from mothers receiving prenatal DHA supplementation in a US cohort. Objective Our objective was to evaluate the efficacy of the prenatal supplementation on both global and granular longitudinal assessments of cognitive and behavioral development. Methods In a randomized double-blind clinical trial, mothers received either 600 mg/d of DHA or a placebo beginning at 14.5 weeks of gestation and capsules were provided until delivery. Children from those pregnancies were followed by cognitive and behavioral assessments administered from 10 mo through 6 y of age. From 301 mothers in the initial study, ∼200 infants completed the longitudinal schedule. Results Although this intervention had been shown to reduce high-risk pregnancies and improve visual attention in infants during the first year, only a few positive long-term effects of prenatal DHA supplementation emerged from analyses of this follow-up. Increases in maternal blood DHA during pregnancy were related to verbal and full scale intelligence quotient (IQ) scores at 5 and 6 y, but these effects disappeared after controlling for SES. Maternal blood DHA concentrations at delivery were unrelated to outcomes, although maternal DHA at enrollment was related to productive vocabulary at 18 mo. Conclusions Although prenatal DHA supplementation substantially reduced early preterm birth and improved visual attention in infancy in this sample, no consistent long-term benefits were observed into childhood. Increases in maternal blood DHA concentration in pregnancy were related to higher IQs but this effect was confounded with SES and disappeared when SES was statistically controlled. This trial was registered at http://www.clinicaltrials.gov as NCT00266825 and NCT02487771.

scholarly journals Long-Term Effects of Activity Status in the Elderly on Cardiorespiratory Capacity, Blood Pressure, Blood Lipids, and Body Composition: A Five-Year Follow-Up Study

2003 ◽  
Vol 3 ◽  
pp. 751-767 ◽  
Author(s):  
Eli Carmeli ◽  
Pini Orbach ◽  
David T. Lowenthal ◽  
Joav Merrick ◽  
Raymond Coleman
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Body Composition ◽  
Oxygen Uptake ◽  
Maximal Oxygen Uptake ◽  
The Elderly ◽  
Long Term Effects ◽  
Highly Active

It is generally recognized that physical activity levels in the elderly do not remain constant over time, and typically there is a marked reduction in physical activities in the elderly. The long-term benefits of regular physical training programs in the elderly are still not fully understood. This is a study of 55 elderly healthy subjects (over 65 years old) and re-evaluated for the effects of different physical activity patterns (sedentary, moderately active, and highly active) on several physiological parameters (pre- and post-training) after a 5-year period (5.30 ± 1.14 years). Measurements included: body composition, blood lipid profiles, resting systolic and diastolic blood pressure, maximal oxygen uptake, and pulmonary function. Results indicated a larger decrease in maximal oxygen uptake (VO2max) in the group of elderly sedentary individuals (1.5 ± 0.5 l/min) compared to the moderately active (1.7 ± 0.6 l/min) and the highly active groups (1.9 ± 0.4 l/min). An active lifestyle was not sufficient to increase the physiological function of an individual.This study could not clearly demonstrate favorable differences for the physically active groups over the sedentary group with regard to several important physiological factors over the 5-year follow-up and it appears that the recommendation for, and the initiation of, adopting active lifestyles may not be sufficient on their own to significantly increase an individual's physiological functioning.

scholarly journals Influence of a Functional Nutrients-Enriched Infant Formula on Language Development in Healthy Children at Four Years Old

Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 535
Author(s):  
Ana Nieto-Ruiz ◽  
Estefanía Diéguez ◽  
Natalia Sepúlveda-Valbuena ◽  
Elvira Catena ◽  
Jesús Jiménez ◽  
...  
Keyword(s):  
Language Development ◽  
Infant Formula ◽  
Low Socioeconomic Status ◽  
Oral Language ◽  
Reference Group ◽  
Language Skills ◽  
Healthy Children ◽  
Long Term Effects ◽  
Double Blind

Nutrition during early life is essential for brain development and establishes the basis for cognitive and language skills development. It is well established that breastfeeding, compared to formula feeding, has been traditionally associated with increased neurodevelopmental scores up to early adulthood. We analyzed the long-term effects of a new infant formula enriched with bioactive compounds on healthy children’s language development at four years old. In a randomized double-blind COGNIS study, 122 children attended the follow-up call at four years. From them, 89 children were fed a standard infant formula (SF, n = 46) or an experimental infant formula enriched with functional nutrients (EF, n = 43) during their first 18 months of life. As a reference group, 33 exclusively breastfed (BF) were included. Language development was assessed using the Oral Language Task of Navarra-Revised (PLON-R). ANCOVA, chi-square test, and logistic regression models were performed. EF children seemed to show higher scores in use of language and oral spontaneous expression than SF children, and both SF and EF groups did not differ from the BF group. Moreover, it seems that SF children were more frequently categorized into “need to improve and delayed” in the use of language than EF children, and might more frequently present “need to improve and delayed” in the PLON-R total score than BF children. Finally, the results suggest that SF children presented a higher risk of suffering language development than BF children. Secondary analysis also showed a slight trend between low socioeconomic status and poorer language skills. The functional compound-enriched infant formula seems to be associated with beneficial long-term effects in the development of child’s language at four years old in a similar way to breastfed infants.

scholarly journals LONG-TERM OUTCOMES OF THE BENEFIT-FINDING GROUP INTERVENTION FOR ALZHEIMER’S FAMILY CAREGIVERS: A DOUBLE-BLIND RCT

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S678-S678
Author(s):  
Sheung-Tak Cheng
Keyword(s):  
Depressive Symptoms ◽  
Group Intervention ◽  
Well Being ◽  
Benefit Finding ◽  
Role Overload ◽  
Long Term Effects ◽  
Post Intervention ◽  
Double Blind

Abstract This study examines the long-term effects of benefit-finding on caregivers’ depressive symptoms (primary outcome), and global burden, role overload, and psychological well-being (secondary outcomes). 96 Hong Kong Chinese caregivers of relatives with Alzheimer’s disease were randomly assigned to receive the benefit-finding intervention (BFT) or one of two control conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE). Caregivers received four biweekly one-to-one interventions of three hours each at their own homes. Participants and raters were blind to experimental assignment. We focused on outcomes measured at 4- and 10-month follow-ups. The trajectories of intervention effects were modeled by BFT x time and BFT x time2 interaction terms. Mixed-effects regression showed significant BFT x time2 interaction effects on depressive symptoms against both control conditions, suggesting diminishing BFT effects over time. Z tests showed that, compared with controls, BFT participants reported substantial reductions in depressive symptoms at 4-month follow-up (d = -0.85 and -0.75 vs. SIM-PE and STD-PE respectively). At 10-month follow-up, BFT was indistinguishable from STD-PE whereas a moderate effect was observed in the comparison with SIM-PE (d = -0.52). In addition, some inconsistent effects on role overload were observed but no effect was found for the other outcome variables. It is concluded that benefit-finding is an efficacious intervention for depressive symptoms in Alzheimer caregivers, with strong effects in the medium-term post-intervention and possible moderate effects in the long-term.

Long-term effects of growth hormone (GH) treatment on body composition and bone mineral density in short children born small-for-gestational-age: six-year follow-up of a randomized controlled GH trial

2007 ◽  
Vol 0 (0) ◽  
pp. 070611021303002-??? ◽  
Author(s):  
Ruben H. Willemsen ◽  
Nicolette J. T. Arends ◽  
Willie M. Bakker-van Waarde ◽  
Maarten Jansen ◽  
Edgar G. A. H. van Mil ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Growth Hormone ◽  
Body Composition ◽  
Long Term Effects ◽  
Mineral Density ◽  
Gh Treatment ◽  
Randomized Controlled ◽  
Short Children

The Long-Term Effects of Homeopathic Treatment of Chronic Headaches: 1 Year Follow Up

Cephalalgia ◽  
2000 ◽  
Vol 20 (9) ◽  
pp. 835-837 ◽  
Author(s):  
H Walach ◽  
T Lowes ◽  
D Mussbach ◽  
U Schamell ◽  
W Springer ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Double Blind Study ◽  
Long Term Effects ◽  
Delayed Effect ◽  
Double Blind ◽  
Homeopathic Treatment ◽  
Headache Diary ◽  
Chronic Headaches

Little is known about the long-term effects of homeopathic treatment. Following a double-blind, placebo-controlled trial of classical homeopathy in chronic headaches, we conducted a complete follow-up study of all trial participants. All patients enrolled in the double-blind study were sent a 6-week headache diary, a follow-up questionnaire. Eighty-seven of the original 98 patients enrolled returned questionnaires, 81 returned diaries. There was no additional change from the end of the trial to the 1-year follow up. The improvement seen at the end of the 12-week trial was stable after 1 year. No differential effects according to treatment after the trial could be seen. Patients with no treatment following the trial had the most improvement after 1 year. Approximately 30% of patients in homeopathic treatment will benefit after 1 year of treatment. There is no indication of a specific, or of a delayed effect of homeopathy.

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