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

NCT03894358 | Completed DMC

• 1 other identifier: INSPIRE
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Fractional iron absorption (%)

  Fractional iron absorption (erythrocyte incorporation of stable iron isotopes after 14 days of meal) from the wheat-based instant cereal containing FeFum and AA, with and without a prebiotic mixture after single dosing

  Day 18

• Fractional iron absorption (%)

  Fractional iron absorption (erythrocyte incorporation of stable iron isotopes after 14 days of meal) from the wheat-based instant cereal containing FeFum and AA, with and without a prebiotic mixture after long-term dosing

  Day 57

Secondary Outcomes (12)

• Change in fecal Bifidobacteria abundance

  Day 18 and day 39

• Plasma ferritin

  Baseline, Day 18, Day 39, Day 57

• Soluble transferrin receptor

  Baseline, Day 18, Day 39, Day 57

• C-reactive protein

  Baseline, Day 18, Day 39, Day 57

• Alpha-1-acid glycoprotein

  Baseline, Day 18, Day 39, Day 57

Study Arms (3)

FeFum and 7.5 g prebiotic mixture

ACTIVE COMPARATOR

Intervention will be 3.6 mg Fe as Ferrous Fumarate and 7.5 g of prebiotic (high dose/low dose) mixture

Dietary Supplement: FeFum and 7.5 g prebiotic mixture

FeFum and 3 g prebiotic mixture

ACTIVE COMPARATOR

Intervention will be 3.6 mg Fe as Ferrous Fumarate and 3 g of prebiotic (high dose/low dose) mixture

Dietary Supplement: FeFum and 3 g prebiotic mixture

FeFum and no prebiotic mixture

ACTIVE COMPARATOR

Intervention will be 3.6 mg Fe as Ferrous Fumarate

Dietary Supplement: Fefum and no prebiotic mixture

Interventions

FeFum and 7.5 g prebiotic mixture DIETARY_SUPPLEMENT

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.

FeFum and 7.5 g prebiotic mixture

FeFum and 3 g prebiotic mixture DIETARY_SUPPLEMENT

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

FeFum and 3 g prebiotic mixture

Fefum and no prebiotic mixture DIETARY_SUPPLEMENT

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

FeFum and no prebiotic mixture

Eligibility Criteria

• Age: 6 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 11 months at baseline
• Anticipated residence in study area for the study duration
• In good health as assessed by professional staff at Msambweni County Referral hospital
• Caregiver is willing to participate and able to comply with study procedures
• Informed consent form has been read and signed by the caregiver (or has been read out to the caregiver)

You may not qualify if:

• Hemoglobin concentration less than 70 g/L
• Severe underweight (Z-score weight-for-age \<-3)
• Severe wasting (Z-score weight-for-height \<-3
• Chronic or acute illness or other conditions that in the opinion of the Principal Investigator (PI) or study pediatrician would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
• Participant taking part in other studies requiring the drawing of blood
• Regular intake (\>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months
• Antibiotic treatment in the past 4 weeks prior to study enrollment

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Danone Nutricia Research: collaborator

Study Sites (1)

Msambweni County Referral Hospital

Msambweni, Kwale County, Kenya

Location

Related Publications (2)

• Mikulic N, Uyoga MA, Stoffel NU, Derrien M, Nyilima S, Kostopoulos I, Roeselers G, Chenoll E, Mwasi E, Pironaci G, Karanja S, Bourdet-Sicard R, Zimmermann MB. Prebiotics increase iron absorption and reduce the adverse effects of iron on the gut microbiome and inflammation: a randomized controlled trial using iron stable isotopes in Kenyan infants. Am J Clin Nutr. 2024 Feb;119(2):456-469. doi: 10.1016/j.ajcnut.2023.11.018. Epub 2023 Nov 30.

  PMID: 38042412 DERIVED

• Derrien M, Mikulic N, Uyoga MA, Chenoll E, Climent E, Howard-Varona A, Nyilima S, Stoffel NU, Karanja S, Kottler R, Stahl B, Zimmermann MB, Bourdet-Sicard R. Gut microbiome function and composition in infants from rural Kenya and association with human milk oligosaccharides. Gut Microbes. 2023 Jan-Dec;15(1):2178793. doi: 10.1080/19490976.2023.2178793.

  PMID: 36794816 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 28, 2019
• Study Start: July 23, 2019
• Primary Completion: January 4, 2020
• Study Completion: January 4, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)