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Role of undigested protein and its effect in humans

To measure the colonic handling of undigested protein and appearance of labelled metabolites (IAA, peptides and metabolome) and bacterial metagenome profiling through specific delivery of intrinsically labelled protein by enteric coated capsule/tablets in adults - CHLP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029835
Enrollment
20
Registered
2020-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

None listed

Interventions

Intervention1: Stable isotopically labelled proteins (13C or 2H) with 13C sodium bicarbonate. Stable isotopically labelled allo-isoleucine (2H): Delivery of intrinsically labelled proteins to the colo

Sponsors

DBT Wellcome Trust India Alliance
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy adult population with no chronic illness, and no reported acute illness for the last 3 months, normal blood biochemistry normal clinical history, good general health

Exclusion criteria

Exclusion criteria: allergies, intolerances, hypersensitivity, severe anemia (Hb <8g/dl), medication use, history of infectious diseases, physical or psychiatric, or surgical intervention.

Design outcomes

Primary

MeasureTime frame
Colonic handling of undigested proteinTimepoint: Two time crossover measurement with bio specimen collection over 24 hours—

Secondary

MeasureTime frame
Evaluation of protein digestion & absorption by metabolomic & peptidomic approach.Timepoint: Enteric coated protein study: 6 h post dose, blood samples will be collected over 24 h, along with breath, urine & fecal sample to measure the appearance of labelled biomolecules & bacterial metagenome profiling. Non-enteric coated protein study: Hourly blood samples will be collected post dose for 6 h. For allo-isoleucine colonoscopy protocol, one time measurement with biospecimen collection over 4 h after the dose administration for colonic absorption.—

Countries

India

Contacts

Public ContactDr Sarita Devi

St. Johns Research Institute

sarita@sjri.res.in09986426938

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026