Effect of amino acid intervention on Environmental Enteric Dysfunction.

To measure the protein digestibility and absorption by minimally invasive stable isotope-based methods and to assess the effect of amino acid based intervention on Environmental Enteric Dysfunction. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069187

Enrollment

420

Registered

2024-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Food supplemented with IAAs (indispensable or essential amino acids): Nutraceutical (2H- and 13C- labelled proteins and unlabelled sugars at baseline and endline) as well as standard co

Eligibility

Inclusion criteria

Inclusion criteria: Stunted LAZ less than 2SD Infants with good general health and without any clinical signs of physical disability Parent, carer or guardian able and willing to give written, informed consent

Exclusion criteria

Exclusion criteria: Under 18 months old Over 36 months old Overweight Have had diarrhea by self-report in the preceding month Allergies, intolerances, hypersensitivity, severe anemia, medication use, history of infectious diseases, physical or psychiatric, or surgical intervention

Design outcomes

Primary

Measure	Time frame
To determine the effects of indispensable amino acid (IAA) supplementation on the change in gut permeability as assessed by the L/R ratio from baseline (day 0) to follow-up (day 28).Timepoint: Baseline (day 0) and end line (day 28)	—

Secondary

Measure	Time frame
Determine the effects of indispensable amino acid (IAA) supplementation on the change in gut digestive capacity as assessed by the 13C-sucrose breath test (13C-SBT) and to determine the effects of indispensable amino acid (IAA) supplementation on the change in plasma protein absorption index by dual stable isotope test (DSIT) from baseline (day 0) to follow-up (day 28) Timepoint: Baseline (day 0) and endline (day 28)	—

Measure

Time frame

Determine the effects of indispensable amino acid (IAA) supplementation on the change in gut digestive capacity as assessed by the 13C-sucrose breath test (13C-SBT) and to determine the effects of indispensable amino acid (IAA) supplementation on the change in plasma protein absorption index by dual stable isotope test (DSIT) from baseline (day 0) to follow-up (day 28) Timepoint: Baseline (day 0) and endline (day 28)

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Countries

India

Contacts

Public ContactDr Sarita Devi

St. John’s Research Institute

sarita@sjri.res.in9986426938

Outcome results