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Different elemental infant formulas show equivalent phosphorus and calcium bioavailability in healthy volunteers
- Source :
- Nutrition Research, 85, 71-83. Elsevier Science
- Publication Year :
- 2021
- Publisher :
- Elsevier Science, 2021.
-
Abstract
- Retrospective chart reviews have reported hypophosphatemia associated with elemental formula use in infants and children with systemic disease involving multiple diagnoses. The present study aims to evaluate the bioavailability of phosphorus from 2 commercial elemental formulas and to test our hypothesis of bioequivalence of the 2 products in healthy volunteers receiving gastric acid-suppressive medication. A single-center, double-blind, randomized, cross-over study was conducted in healthy volunteers with esomeprazole-induced hypochlorhydria. After a standardized low phosphorus meal followed by overnight fasting, subjects consumed 1 gram of phosphorus in a single oral dose of 1217 kcal of Product A (Neocate) or Product B (Elecare). The alternate product was given following a 1-week washout period. Blood and urine were collected at baseline and different time-points for up to 6 hours after product consumption. Area-under-the-curve (AUC) and peak values (C-peak) for serum phosphate and calcium and urinary creatinine-corrected phosphate and calcium were assessed for bioequivalence of Products A and B. Results show that the geometric mean ra tio (GMR) and 90% CI for serum phosphate were 1.041 (0.998-1.086) and 1.020 (0.963-1.080) for AUC(0-360) and C-peak, respectively, meeting the predetermined criteria for bioequivalence. Urinary creatinine-corrected phosphate followed a similar pattern after intake of Product A and B, but did not reach bioequivalence criteria (GMR: AUC(70-370) = 1.105 (0.918-1.330); C-peak = 1.182 (1.040-1.343)). Serum calcium concentrations (GMR: AUC(0-360) = 1.002 (0.9961.009); C-peak = 0.991 (0.983-0.999)) and urinary creatinine-corrected calcium excretion (GMR: AUC(70-370) = 1.117 (1.023-1.219); C-peak = 1.157 (1.073-1.247)) demonstrated bioequivalence of the products. In conclusion, both elemental infant formulas showed equivalent serum phosphorus and calcium bioavailability in healthy volunteers even if combined with treatment with acid-suppressive medication. (c) 2020 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/ )
- Subjects :
- 0301 basic medicine
Blood Glucose
Male
Neocate
Endocrinology, Diabetes and Metabolism
Urine
Gastroenterology
SUPPLEMENTATION
GLUCOSE
0302 clinical medicine
Endocrinology
Insulin
Amino Acids
ACID-BASED FORMULA
Nutrition and Dietetics
Cross-Over Studies
Achlorhydria
COWS MILK
cow's milk allergy
Healthy Volunteers
Infant Formula
HYPOALLERGENICITY
Parathyroid Hormone
GROWTH
Female
HYPOPHOSPHATEMIA
Hypophosphatemia
Adult
medicine.medical_specialty
Carbohydrates
chemistry.chemical_element
Biological Availability
030209 endocrinology & metabolism
Phosphate
Calcium
Bioequivalence
Phosphates
Excretion
03 medical and health sciences
Young Adult
cross-over study
Double-Blind Method
Internal medicine
medicine
Humans
TOLERANCE
030109 nutrition & dietetics
business.industry
amino acid-based formula
Phosphorus
MILK PROTEIN ALLERGY
medicine.disease
Alkaline Phosphatase
Crossover study
Dietary Fats
Bioavailability
chemistry
Therapeutic Equivalency
business
Subjects
Details
- Language :
- English
- ISSN :
- 02715317
- Volume :
- 85
- Database :
- OpenAIRE
- Journal :
- Nutrition Research
- Accession number :
- edsair.doi.dedup.....e09b42f3478188cc6cbb8deed0fa5400