Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides

NCT04774016 | Completed

• 1 other identifier: 18.15.INF
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The co-primary objectives of this study are: 1) to investigate the effect adding a synbiotic (combination of a pre-and probiotic) to iron-fortified follow-up formula (FUF) on iron bioavailability, and 2) to investigate the effect adding Human Milk Oligosaccharides (HMOs) to iron-fortified FUF on iron bioavailability in 10-14 month-old Thai children.

Conditions

Iron Absorption

Outcome Measures

Primary Outcomes (4)

• Fractional Iron Absorption (FIA) from an iron-fortified follow-up infant formula with and without the addition of a synbiotic

  FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.

  Measured 28 days after administration of last test formula

• Fractional Iron Absorption (FIA) from an iron-fortified follow-up infant formula with and without the addition of a synbiotic

  FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.

  Measured 14 days after administration of last test formula

• FIA from an iron-fortified follow-up formula with and without the addition of human oligosaccharides (HMOs)

  FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.

  Measured 28 days after administration of last test formula

• FIA from an iron-fortified follow-up formula with and without the addition of human oligosaccharides (HMOs)

  FIA from test formulas will be determined based on the shift of the iron isotope ratios in whole blood.

  Measured 14 days after administration of last test formula

Secondary Outcomes (12)

• Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on Iron status (haemoglobin [Hb])

  At baseline and last study visit (day 40)

• Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on Iron status (plasma ferritin [PF])

  At baseline and last study visit (day 40)

• Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on Iron status (soluble transferrin receptor [sTfR])

  At baseline and last study visit (day 40)

• Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on inflammation status ((C-reactive protein [CRP])

  At baseline and last study visit (day 40)

• Effects of feeding an iron-fortified FUF with added synbiotic (Formula B) for 25 days on inflammation status (alpha-1-acid glycoprotein [AGP]))

  At baseline and last study visit (day 40)

Study Arms (3)

Test formula C

EXPERIMENTAL

Other: Test formula C with HMOs

Test formula B

EXPERIMENTAL

Other: Test formula B with synbiotic

Test formula A

PLACEBO COMPARATOR

Other: Test formula A without added pre- and pro-biotic

Interventions

Test formula A without added pre- and pro-biotic OTHER

An identical formula as test formulas fortified with 2.20 mg iron as FeSO4-58 and 0.05 mg native iron per serving (235 ml), but without added pre- or probiotic.

Test formula A

Test formula B with synbiotic OTHER

Test formula fortified with 2.20 mg iron as FeSO4-57 and 0.05 mg native iron per serving (235 ml) and added synbiotic.

Test formula B

Test formula C with HMOs OTHER

Test formula fortified with 2.20 mg iron as FeSO4-54 and 0.05 mg native iron per serving (235 ml) and added HMOs.

Test formula C

Eligibility Criteria

• Age: 40 Weeks - 56 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent has been obtained from the parents/legally acceptable representative
• Child aged 40-56 weeks (± 3 weeks)
• Child exhibits no clinical signs/symptoms of chronic disease or acute illness
• Capillary Hb ≥70 g/L
• Anticipated residence in the area for the study duration
• Z-scores for weight-for-age and weight-for-length both \>-3, if the infant is severely underweight or severely malnourished.
• Singleton, full-term gestation birth (≥37 weeks)
• Birth weight ≥2.5 kg and ≤4.5 kg

You may not qualify if:

• Child exhibits clinical signs/symptoms of chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth
• Child received vitamin and mineral supplements in the 2 weeks prior to enrollment
• Child is exclusively breastfed
• Child received antibiotic treatments in the 4 weeks prior to enrollment
• Parents or caretakers not willing/not able to comply with the requirements of the study protocol
• Child has allergy or intolerance to cows' milk protein or lactose, or severe food allergies
• Child is participating in any other interventional clinical trial that would interfere with study outcomes

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Amphawa Hospital

Samut Sakhon, Thailand

Location

Related Publications (1)

• Scheuchzer P, Sinawat S, Donze AS, Zeder C, Sabatier M, Garcia-Garcera M, Ricci C, Kamontham T, Zimmermann MB, Baumgartner J. Iron Absorption from an Iron-Fortified Follow-Up Formula with and without the Addition of a Synbiotic or a Human-Identical Milk Oligosaccharide: A Randomized Crossover Stable Isotope Study in Young Thai Children. J Nutr. 2024 Oct;154(10):2988-2998. doi: 10.1016/j.tjnut.2024.08.016. Epub 2024 Aug 22.

  PMID: 39179207 DERIVED

MeSH Terms

Interventions

Synbiotics; Health Maintenance Organizations

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages; Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: February 26, 2021
• Study Start: November 18, 2020
• Primary Completion: March 23, 2021
• Study Completion: June 7, 2021
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

TH (1)