NCT05047757

Brief Summary

The goal of the project is to determine the ileal amino acid digestibility of Favabean in healthy subjects equipped with naso-ileal tube. For this purpose, Favabean will be intrinsically labelled with 15N using 15N fertilizer. This procedure will be realized in Finland and the labelled material will be sent to the Unit PNCA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

June 15, 2021

Last Update Submit

February 20, 2024

Conditions

Ileal Digestibility of Amino Acids

Keywords

digestibilityhealthy humansnasoileal tubesstable isotopeslegumes

Outcome Measures

Primary Outcomes (1)

  • Ileal digestibility of protein and amino acids

    The measurement of nitrogen (mmol) and 15N enrichment (atom %) in ileal samples allow to determine the amount of dietary nitrogen in the lumen. The measurement of amino acid concentration (mmol) and their individual 15N enrichment (atom %) allow the determination of dietary amino acids remaining in the lumen. Dietary amino acids and dietary nitrogen that are recovered in the ileal samples are then considered as non absorbed.

    -30 minutes to 8 hours after the test meal

Secondary Outcomes (6)

  • Net Postprandial Protein Utilization (NPPU)

    0 to 8 hours after the test meal

  • gut microbiota in response to the ingestion of 15N fava bean

    0 to 2 days after the test meal

  • Nitrogen metabolites in blood in response to the ingestion of 15N fava bean

    0 to 8 hours after the test meal

  • Plasma glucose in blood in response to the ingestion of 15N fava bean

    0 to 8 hours after the test meal

  • Plasma insulin in blood in response to the ingestion of 15N fava bean

    0 to 8 hours after the test meal

  • +1 more secondary outcomes

Study Arms (1)

Fava bean

EXPERIMENTAL

The intervention consists in a test meal containing 250 g of cooked and peeled favabean, to provide 20 g protein. Fava bean are intrinsically labelled with 15N.

Dietary Supplement: Test meal with 15N labeled favabean

Interventions

Test meal with 15N labeled favabeanDIETARY_SUPPLEMENT

Ingestion of a 15N labeled test meal. Subjects are equipped with a nasoileal tube. 15N is followed in biological fluids (plasma, effluents, urines).

Fava bean

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \<BMI\<30
  • Good health (WHO=0)
  • For woman: use of birth control

You may not qualify if:

  • allergy against legumes
  • allergy against latex
  • pregnant women
  • Positive serology for AgHBS, AcHbc, HCV, HIV
  • Positive PCR test for SARS-Cov2
  • Anemia
  • Excessive alcohool consumption
  • Hypertension, diabetes, digestive, hepatic or renal diseases, cardiac disease
  • Exercice\>7h/week
  • Blood donation within 3 months before the study
  • Participation to another clinical study within 3 months before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

Bobigny, Île-de-France Region, 93000, France

Location

Related Publications (1)

  • Itkonen ST, Calvez J, Airinei G, Chapelais M, Khodorova N, Sahaka M, Benamouzig R, Stoddard FL, Simojoki A, Pajari AM, Gaudichon C. True Ileal Amino Acid Digestibility and Protein Quality of 15N-Labeled Faba Bean in Healthy Humans. J Nutr. 2024 Apr;154(4):1165-1174. doi: 10.1016/j.tjnut.2024.01.030. Epub 2024 Feb 3.

    PMID: 38311065DERIVED

Study Officials

  • Claire Gaudichon, PhD, Prof

    AgroParisTech

    STUDY DIRECTOR

  • Robert Benamouzig, MD, Prof

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2021

First Posted

September 17, 2021

Study Start

October 18, 2021

Primary Completion

January 1, 2023

Study Completion

April 4, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)