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The Digestion of Protein Powders in Healthy Participants Using SIMBA and LIMBA Capsule

NCT06394687 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-29

No results posted yet for this study

Summary

This study aims to understand how the Milk Protein Concentrate/Fast Protein (MCP/FP) investigational product (IP) compares to a control the Micellar Casein Isolate/Slow Protein (MCI/SP) product in healthy volunteers. It involves two phases where participants will try both products. The main goal is to measure the type and rate of amino acids quickly in the small intestine after consuming the protein products and how this relates to gastric emptying.

Conditions

  • Amino Acid Change
  • Food Science
  • Nutrition
  • Digestion Rate
  • Microtia

Interventions

DIETARY_SUPPLEMENT

Milk Protein Concentrate

Milk Protein Concentrate is a powdered dairy product made by removing most of the water from milk and contains a protein content below 90% on a dry matter basis. The product has been modified where some of the colloidal calcium phosphate component is reduced, which results in the dissociation of some of casein micelles, forming loose sub-micelle structures. This change modifies the digestion behaviour to be significantly faster.

DIETARY_SUPPLEMENT

Micellar Casein Isolate

Micellar casein isolate is a type of protein supplement derived from milk. It belongs to the casein family of proteins, which includes various forms such as micellar casein, casein hydrolysate, and caseinates. During digestion micellar casein coagulates with both gastric acidification and enzymatic hydrolysis by pepsin, forming large stable curds which slow gastric emptying and provide a slower absorption of amino acids over time.

Sponsors & Collaborators

  • Nimble Science Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2025-06-12
Completion
2025-06-12

Countries

  • Canada

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 NCT06394687 on ClinicalTrials.gov