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

NCT06394687 | Active Not Recruiting

• 1 other identifier: NIMCSF162
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mircobiome

Outcome Measures

Primary Outcomes (1)

• Time to presentation of the peptides in the small intestine by SIMBA/LIMBA capsule

  Time to presentation of IP or Control peptides to the small intestine compared within subjects, measured by proteomic analysis from SIMBA/LIMBA capsules located in the small intestine based on X-ray confirmation. eg. T-90 min IP vs T-90 min Control, T-60 min IP vs T-60 min Control, etc),

  From 0 minute to 240 minutes after ingestion of the capsule per intervention period

Secondary Outcomes (5)

• Time to presentation of the peptides in the small intestine by blood analysis

  From 0 minute to 240 minutes after ingestion of the protein product

• Determination of peptide composition

  From 0 minute to 240 minutes after ingestion of the protein product per intervention period

• Determination of proteolysis rate

  From 0 minute to 240 minutes after ingestion of the protein product per intervention period

• Determination of metabolites from various samples

  From 0 minute to 240 minutes after ingestion of the capsule per intervention period

• Characterization of microbiota composition by metagenomic analysis

  From 0 minute to 240 minutes after ingestion of the capsule per intervention period

Study Arms (2)

MPC/FP to MCI/SP

ACTIVE COMPARATOR

Participants ingest the MPC/FP protein product for their first intervention period, then MCI/SP for their second intervention period.

Dietary Supplement: Milk Protein Concentrate; Dietary Supplement: Micellar Casein Isolate

MCI/SP to MPC/FP

ACTIVE COMPARATOR

Participants ingest the MCI/SP protein product for their first intervention period, then MPC/FP for their second intervention period.

Dietary Supplement: Milk Protein Concentrate; Dietary Supplement: Micellar Casein Isolate

Interventions

Milk Protein Concentrate DIETARY_SUPPLEMENT

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.

Also known as: Fast Protein

MCI/SP to MPC/FP; MPC/FP to MCI/SP

Micellar Casein Isolate DIETARY_SUPPLEMENT

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.

Also known as: Slow Protein

MCI/SP to MPC/FP; MPC/FP to MCI/SP

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed Informed Consent; willing \& able to comply with study procedures.
• Willing to maintain their diet and physical activity levels during the study.
• Able to swallow a size-00 capsule (23mm length).
• No planned change in diet or medical interventions during the study duration

You may not qualify if:

• Use of regular prescription medications, including antihypertensives, anti-inflammatory drugs, corticosteroids, immunosuppressants, antidepressants, antipsychotics, anti-diabetic medications, and anti-arrhythmic agents, which in the opinion of the investigator, would adversely affect study safety or outcome.
• Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.
• History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.
• Known history abdominal radiation treatment.
• Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, GLP-1 analogues); laxative use is allowed if it is kept unchanged in the week prior to the study visit. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA/LIMBA capsules and PPI treatment is resumed only 4 hours thereafter.
• Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
• Any significant gastrointestinal, heart, liver, lung, kidney, blood, endocrine or nervous system disease, which in the opinion of the investigator, would adversely affect study safety or outcome.
• Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable).
• History or diagnosis of immunological or infectious disease (hepatitis, tuberculosis, HIV, Parkinson's).
• History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.
• Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.
• Consumption of probiotic or prebiotic supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.
• Any prior Fecal Microbiota Transplantation.
• Colon cleanses/bowel prep for 2 weeks
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Nimble Science Ltd.: lead

Study Sites (1)

Cumming School of Medicine

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Congenital Microtia

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Protein powders are identical in appearance and tase
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, single-blind, crossover, clinical study in healthy participants comparing the effect of a single ingestion of MPC/FP vs MCI/SP protein powder formulations on small intestinal proteomic profile and gastric emptying. The study will enroll up to 20 healthy participants who will consume both MCP/FP and MCI/SP products in randomized order with a washout period in between. Randomization will occur in blocks of 4, with two participants per product.

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: May 1, 2024
• Study Start: November 10, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

CA (1)