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| Name | Class |
|---|---|
| University College, London | OTHER |
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The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.
Obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease (CVD), the critical windows for these programming effects, and the mechanisms of action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Modified infant formula given from 3 to 12 months of age, as per standard requirement. |
|
| Control Group | Active Comparator | Standard infant formula given from 3 to 12 months of age, as per standard requirement. |
|
| Breast-fed Reference Group | No Intervention | Non-randomized infants who are predominantly breast-fed at time of enrollment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified infant formula | Other | Test formula with lower protein content than standard formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant weight gain | Rate of weight gain (g/d) | Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index (BMI)-for-age Z-score | Based on World Health Organization (WHO) growth standards | Age 2 years (+/- 1 month) |
| Height-for-age Z-score | Based on WHO growth standards |
| Measure | Description | Time Frame |
|---|---|---|
| Infant weight gain | Rate of weight gain (g/d) | Between 6 and 12 months |
| Weight | Body weight (kg) | Ages 4, 5, 6, 12 and 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atul Singhal, MD | Childhood Nutrition Research Centre, University College London, Institute of Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCL Institute of Child Health | London | WC1N 1EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37929831 | Derived | Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Prospective, randomized, double-blind with nonrandomized breast-fed reference group
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| Standard infant formula | Other | Standard infant formula |
|
| Age 2 years (+/- 1 month) |
| Adiposity | Sum of 4 skinfolds (triceps, biceps, sub-scapular, supra-iliac) | Age 2 years (+/- 1 month) |
| Fat mass | Deuterium dilution (assessed in subset) | Age 2 years (+/- 1 month) |
| Length or height | Length or height (cm) | Ages 4, 5, 6, 12 and 24 months |
| Head circumference | Head circumference (cm) | Ages 4, 5, 6, 12 and 24 months |
| Body mass index | Weight and length or height will be combined to report BMI in kg/m^2 | Ages 6, 12 and 24 months |
| Weight-for-age Z-score | Based on WHO growth standards | Ages 14 weeks and 4, 5, 6, 12 and 24 months |
| Weight-for-length Z-score | Based on WHO growth standards | Ages 14 weeks and 4, 5, 6, 12 and 24 months |
| Height-for-age Z-score | Based on WHO growth standards | Ages 14 weeks and 4, 5, 6, and 12 months |
| BMI-for-age Z-score | Based on WHO growth standards | Ages 14 weeks and 4, 5, 6, and 12 months |
| Adverse events | Safety | Ages 14 weeks and 4, 5, 6, 9, 12 and 24 months |
| Feeding intake | Infant feeding questionnaire | Ages 14 weeks and 4, 5, 6, and 12 months |
| Feeding tolerance | GI symptom and stool pattern questionnaire | Ages 14 weeks and 4, 5, 6, and 12 months |
| Metabolic markers of cardiovascular health | Blood sample (in a subset) | Ages 6 and 12 months |
| Blood pressure | Systolic and diastolic blood pressure (in a subset) | At age 12 and 24 months |
| Appetite and feeding / eating behavior | Baby and Children's Eating Behavior Questionnaire | Ages 14 weeks and 4, 5, 6, and 24 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |