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Effects of Complementary Feeding With Different Protein-Rich Foods on Infant Growth and Gut Health: Study Protocol.

ABSTRACT: Background: An urgent need exists for evidence-based dietary guidance early in life, particularly regarding protein intake. However, a significant knowledge gap exists in the effects of protein-rich foods on growth and development during early complementary feeding. Methods: This is a randomized controlled trial of infant growth and gut health (primary outcomes). We directly compare the effects of dietary patterns with common protein-rich foods (meat, dairy, plant) on infant growth trajectories and gut microbiota development (monthly assessments) during early complementary feeding in both breast- and formula-fed infants. Five-month-old infants (up to n = 300) are randomized to a meat-, dairy-, plant-based complementary diet or a reference group (standard of care) from 5 to 12 months of age, with a 24-month follow-up assessment. Infants are matched for sex, mode of delivery and mode of feeding using stratified randomization. Growth assessments include length, weight, head circumference and body composition. Gut microbiota assessments include both 16S rRNA profiling and metagenomics sequencing. The primary analyses will evaluate the longitudinal effects of the different diets on both anthropometric measures and gut microbiota. The secondary analysis will evaluate the potential associations between gut microbiota and infant growth. Discussion: Findings are expected to have significant scientific and health implications for identifying beneficial gut microbial changes and dietary patterns and for informing dietary interventions to prevent the risk of overweight and later obesity, and promote optimal health. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT05012930.

SUBMITTER: Tang M

PROVIDER: S-EPMC8793676 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:What we eat as infants and children carries long-term consequences. Apart from breastfeeding, the composition of the complementary diet, i.e. the foods given to the infant during the transition from breast milk/infant formula to regular family foods affects the child's future health. A high intake of protein, a low intake of fruits, vegetables and fish and an unfavorable distribution between polyunsaturated and saturated fats are considered to be associate with health risks, e.g. obesity, type 2 diabetes and dyslipidemia later in life. METHODS:In a randomized, controlled study from 6 to 18?months of age we will compare the currently recommended, Swedish complementary diet to one based on Nordic foods, i.e. an increased intake of fruits, berries, vegetables, tubers, whole-grain and game, and a lower intake of sweets, dairy, meat and poultry, with lower protein content (30% decrease), a higher intake of vegetable fats and fish and a systematic introduction of fruits and greens. The main outcomes are body composition (fat and fat-free mass measured with deuterium), metabolic and inflammatory biomarkers (associated with the amount of body fat) in blood and urine, gut microbiota (thought to be the link between early diet, metabolism and diseases such as obesity and insulin resistance) and blood pressure. We will also measure the participants' energy and nutrient intake, eating behavior and temperament through validated questionnaires, acceptance of new and unfamiliar foods through video-taped test meals and assessment of cognitive development, which we believe can be influenced through an increased intake of fish and milk fats, notably milk fat globule membranes (MFGM). DISCUSSION:If the results are what we expect, i.e. improved body composition and a less obesogenic, diabetogenic and inflammatory metabolism and gut microbiota composition, a more sustainable nutrient intake for future health and an increased acceptance of healthy foods, they will have a profound impact on the dietary recommendations to infants in Sweden and elsewhere, their eating habits later in life and subsequently their long-term health. TRIAL REGISTRATION:NCT02634749 . Registration date 18 December 2015.

Project description:ImportanceBaby-led approaches to complementary feeding, which promote self-feeding of all nonliquid foods are proposed to improve energy self-regulation and lower obesity risk. However, to date, no randomized clinical trials have studied this proposition.ObjectiveTo determine whether a baby-led approach to complementary feeding results in a lower body mass index (BMI) than traditional spoon-feeding.Design, setting, and participantsThe 2-year Baby-Led Introduction to Solids (BLISS) randomized clinical trial recruited 206 women (168 [81.6%] of European ancestry; 85 [41.3%] primiparous) in late pregnancy from December 19, 2012, through March 17, 2014, as part of a community intervention in Dunedin, New Zealand. Women were randomized to a control condition (n = 101) or the BLISS intervention (n = 105) after stratification for parity and education. All outcomes were collected by staff blinded to group randomization, and no participants withdrew because of an adverse event. Data were analyzed based on intention to treat.InterventionsMothers in the BLISS group received lactation consultant support (≥5 contacts) to extend exclusive breastfeeding and delay introduction of complementary foods until 6 months of age and 3 personalized face-to-face contacts (at 5.5, 7.0, and 9.0 months).Main outcomes and measuresThe primary outcome was BMI z score (at 12 and 24 months). Secondary outcomes included energy self-regulation and eating behaviors assessed with questionnaires at 6, 12, and 24 months and energy intake assessed with 3-day weighed diet records at 7, 12, and 24 months.ResultsAmong the 206 participants (mean [SD] age, 31.3 [5.6] years), 166 were available for analysis at 24 months (retention, 80.5%). The mean (SD) BMI z score was not significantly different at 12 months (control group, 0.20 [0.89]; BLISS group, 0.44 [1.13]; adjusted difference, 0.21; 95% CI, -0.07 to 0.48) or at 24 months (control group, 0.24 [1.01]; BLISS group, 0.39 [1.04]; adjusted difference, 0.16; 95% CI, -0.13 to 0.45). At 24 months, 5 of 78 infants (6.4%) were overweight (BMI≥95th percentile) in the control group compared with 9 of 87 (10.3%) in the BLISS group (relative risk, 1.8; 95% CI, 0.6-5.7). Lower satiety responsiveness was observed in BLISS infants at 24 months (adjusted difference, -0.24; 95% CI, -0.41 to -0.07). Parents also reported less food fussiness (adjusted difference, -0.33; 95% CI, -0.51 to -0.14) and greater enjoyment of food (adjusted difference, 0.25; 95% CI, 0.07 to 0.43) at 12 months in BLISS infants. Estimated differences in energy intake were 55 kJ (95% CI, -284 to 395 kJ) at 12 months and 143 kJ (95% CI, -241 to 526 kJ) at 24 months.Conclusions and relevanceA baby-led approach to complementary feeding did not result in more appropriate BMI than traditional spoon-feeding, although children were reported to have less food fussiness. Further research should determine whether these findings apply to individuals using unmodified baby-led weaning.Trial registrationhttp://anzctr.org.au Identifier: ACTRN12612001133820.

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Effects of Complementary Feeding With Different Protein-Rich Foods on Infant Growth and Gut Health: Study Protocol.

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