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Iron Absorption From a Wheat-based Instant Cereal:Gut and Stable Isotope Studies in Kenyan Infants

NCT03894358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2020-05-12

No results posted yet for this study

Summary

The aim of this study is to measure the effect of a prebiotic (high dose/low dose) mixture at different doses within a wheat-based instant cereal, on fractional iron absorption (FIA), gut microbiota and inflammation after three weeks. FIA will be compared with and without three weeks of pre-feeding with two different doses of the prebiotic mixture.

Conditions

  • Iron Absorption
  • Gut Microbiota

Interventions

DIETARY_SUPPLEMENT

FeFum and 7.5 g prebiotic mixture

The 3 weeks intervention will consist of 24 g of wheat-based instant cereal and 90 ml of water per portion and will contain 3.6 mg FeFum and AA (molar ratio Fe:AA between 2.5 and 3) plus 7.5 g prebiotics mixture The absorption study test meals will consist of 24 g wheat-based instant cereal and 90 ml of water per portion and additionally: Test meal 1 will be composed of: 3.6 mg of Fe as 57FeFum and 0 g prebiotic mixture added extrinsically. Test meal 2 will be composed of: 3.6 mg of Fe as 1.5 mg iron as 58FeFum, 2.09 mg iron as 56FeFum and 7.5 g prebiotic mixture added extrinsically.

DIETARY_SUPPLEMENT

FeFum and 3 g prebiotic mixture

Standard wheat-based instant cereal containing 3.6 mg FeFum and AA (molar ratio Fe:AA between 2.5 and 3) plus 3 g prebiotics mixture per portion

DIETARY_SUPPLEMENT

Fefum and no prebiotic mixture

Standard wheat-based instant cereal containing 3.6 mg FeFum and AA (molar ratio Fe:AA between 2.5 and 3) per portion.

Sponsors & Collaborators

  • Danone Nutricia Research

    collaborator INDUSTRY

  • Swiss Federal Institute of Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
11 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2020-01-04
Completion
2020-01-04

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03894358 on ClinicalTrials.gov