Amino Acid ChangeNCT06394687
The Digestion of Protein Powders in Healthy Participants Using SIMBA and LIMBA Capsule
A study testing Milk Protein Concentrate and Micellar Casein Isolate in people with Amino Acid Change and Food Science, run by Nimble Science Ltd. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acid Change, Food Science, Nutrition
- What is being tested?
- Milk Protein Concentrate and Micellar Casein Isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2024to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20 to 55 years old at inclusion in the study, both female and male subjects.
- 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
Who cannot join
- 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.
Show all 20Show fewer
- 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.
- Planning to become pregnant.
- Alcohol or drug abuse.
- Milk or soy allergy
- Lactose intolerant
- Vegan diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Cross-over Study of The Digestion of Protein Powders in Healthy Participants Using SIMBA and LIMBA Capsule
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.
Read the detailed description
This study aims to compare how MPC and MCI are digested on their journey to the colon, and how the proteins are digested once in colon. Traditional methods for sampling the small intestine have limitations, so a new capsule technology will be used for non-invasive sampling.
Understanding how protein supplements like MPC and MCI are digested is crucial for determining their effectiveness and suitability for various purposes. By comparing these two types of supplements, one can gain insights into their unique digestion profiles and how they interact with the body. Additionally, analyzing how these supplements affect blood amino acid levels and stool profiles can offer further insights into their impact on the body's metabolism and gut health.
To collect samples from the small intestine, the SIMBA Capsule (designed by Nimble Science Ltd) will be used. This device offers a simple, non-invasive, and painless alternative to obtain a sample of the small intestine, suitable for laboratory analysis. The SIMBA capsule consists of a small pill sized container within a specially coated shell and is the size of capsules available in the market for food supplements such as fish oils. When swallowed, the capsule's coated shell (which resists the acidic stomach and dissolves in the small intestine) will pass through the stomach into the small intestine. Once the shell is dissolved, the capsule can collect a fluid sample from the small intestine through the designed openings that are now exposed. Additionally, the small intestinal fluid softens a latch on a spring-loaded plunger which leads to closing the openings and sealing the sampled fluid contents within the container.
In addition, there is the LIMBA capsule, which is functionally similar to the SIMBA capsule. The only difference is that the coating of the LIMBA capsule takes longer to dissolve. This allows the LIMBA capsule to collect samples from the large intestine. The coating has no effect on the rate the capsule is expelled.
By using technology like the SIMBA/LIMBA capsule for non-invasive sampling, one can overcome the limitations of traditional methods and obtain more accurate data on the digestion of these protein supplements. This will enable one to make informed recommendations regarding their usage and potentially identify novel applications for these products in clinical and nutritional settings. Ultimately, this study aims to enhance one's understanding of protein supplement metabolism and provide evidence-based guidance for individuals seeking to optimize their dietary intake for better health outcomes.
- Conditions
- Amino Acid Change, Food Science, Nutrition, Digestion Rate, Microtia
- Being tested
- Milk Protein Concentrate, Micellar Casein Isolate
- Keywords
- Mircobiome
- Medical subject headings
- Congenital Microtia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Protein ConcentrateDietary supplement
Also called Fast Protein
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.
Micellar Casein IsolateDietary supplement
Also called Slow Protein
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Milk Protein Concentrate; Dietary Supplement: Micellar Casein Isolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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),
Measured: 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
Time to presentation of IP or Control peptides to the small intestine compared within subjects, measured by total amino acid analysis from blood samples difference in small intestinal proteomic profile between IP and Control phases based on PCA plot. (Maximum difference is defined by comparing the various SIMBA/LIMBA capsules within each patient, eg. T-90 min IP vs T-90 min Control, T-60 min IP vs T-60 min Control, etc),
Measured: From 0 minute to 240 minutes after ingestion of the protein product
Determination of peptide composition
The composition of milk-derived peptides by proteomic analysis. Statistical and mathematical analyses be employed to characterize the peptide profiles.
Measured: From 0 minute to 240 minutes after ingestion of the protein product per intervention period
Determination of proteolysis rate
The rate of milk-derived peptide proteolysis, gastric emptying, and nutrient absorption of IP or Control peptides. Statistical and mathematical analyses be employed to discern correlations and causative relationships among these processes.
Measured: From 0 minute to 240 minutes after ingestion of the protein product per intervention period
Determination of metabolites from various samples
The presence of the milk-derived peptide metabolites in small intestine, feces, and blood samples, following the IP or control intervention. Method of analysis being metabolomic technology.
Measured: From 0 minute to 240 minutes after ingestion of the capsule per intervention period
Characterization of microbiota composition by metagenomic analysis
Qualitative investigation of gut bacteria participation in the metabolism of dietary proteins, influencing the breakdown of peptides and amino acids during digestion, based on microbiome profiles compared across subjects.
Measured: From 0 minute to 240 minutes after ingestion of the capsule per intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start10 Nov 2024
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amino Acid ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nimble Science Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394687
- Sponsor's protocol ID
- NIMCSF162
- Status last verified
- Oct 2026
- First submitted
- 5 Apr 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Study of The Digestion of Protein Powders in Healthy Participants Using SIMBA and LIMBA Capsule
- ClinicalTrials.gov ID
- NCT06394687
- Acronym / sponsor ID
- NIMCSF162
- Conditions
- Amino Acid Change, Food Science, Nutrition, Digestion Rate, Microtia
- Keywords
- Mircobiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nimble Science Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to compare how MPC and MCI are digested on their journey to the colon, and how the proteins are digested once in colon. Traditional methods for sampling the small intestine have limitations, so a new capsule technology will be used for non-invasive sampling.
Understanding how protein supplements like MPC and MCI are digested is crucial for determining their effectiveness and suitability for various purposes. By comparing these two types of supplements, one can gain insights into their unique digestion profiles and how they interact with the body. Additionally, analyzing how these supplements affect blood amino acid levels and stool profiles can offer further insights into their impact on the body's metabolism and gut health.
To collect samples from the small intestine, the SIMBA Capsule (designed by Nimble Science Ltd) will be used. This device offers a simple, non-invasive, and painless alternative to obtain a sample of the small intestine, suitable for laboratory analysis. The SIMBA capsule consists of a small pill sized container within a specially coated shell and is the size of capsules available in the market for food supplements such as fish oils. When swallowed, the capsule's coated shell (which resists the acidic stomach and dissolves in the small intestine) will pass through the stomach into the small intestine. Once the shell is dissolved, the capsule can collect a fluid sample from the small intestine through the designed openings that are now exposed. Additionally, the small intestinal fluid softens a latch on a spring-loaded plunger which leads to closing the openings and sealing the sampled fluid contents within the container.
In addition, there is the LIMBA capsule, which is functionally similar to the SIMBA capsule. The only difference is that the coating of the LIMBA capsule takes longer to dissolve. This allows the LIMBA capsule to collect samples from the large intestine. The coating has no effect on the rate the capsule is expelled.
By using technology like the SIMBA/LIMBA capsule for non-invasive sampling, one can overcome the limitations of traditional methods and obtain more accurate data on the digestion of these protein supplements. This will enable one to make informed recommendations regarding their usage and potentially identify novel applications for these products in clinical and nutritional settings. Ultimately, this study aims to enhance one's understanding of protein supplement metabolism and provide evidence-based guidance for individuals seeking to optimize their dietary intake for better health outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MPC/FP to MCI/SP | Active comparator | Dietary Supplement: Milk Protein Concentrate, Dietary Supplement: Micellar Casein IsolateParticipants ingest the MPC/FP protein product for their first intervention period, then MCI/SP for their second intervention period. |
| MCI/SP to MPC/FP | Active comparator | Dietary Supplement: Milk Protein Concentrate, Dietary Supplement: Micellar Casein IsolateParticipants ingest the MCI/SP protein product for their first intervention period, then MPC/FP for their second intervention period. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 20 to 55 years old at inclusion in the study, both female and male subjects.
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk Protein ConcentrateAlso: Fast ProteinMilk 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 | MCI/SP to MPC/FP, MPC/FP to MCI/SP |
| Micellar Casein IsolateAlso: Slow ProteinMicellar 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. | Dietary supplement | MCI/SP to MPC/FP, MPC/FP to MCI/SP |
Primary outcome
Time to presentation of the peptides in the small intestine by SIMBA/LIMBA capsule
Time frame: From 0 minute to 240 minutes after ingestion of the capsule per intervention period
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),
5 secondary outcomes
Time to presentation of the peptides in the small intestine by blood analysis
Time frame: From 0 minute to 240 minutes after ingestion of the protein product
Determination of peptide composition
Time frame: From 0 minute to 240 minutes after ingestion of the protein product per intervention period
Determination of proteolysis rate
Time frame: From 0 minute to 240 minutes after ingestion of the protein product per intervention period
Determination of metabolites from various samples
Time frame: From 0 minute to 240 minutes after ingestion of the capsule per intervention period
Characterization of microbiota composition by metagenomic analysis
Time frame: From 0 minute to 240 minutes after ingestion of the capsule per intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk Protein Concentrate and Micellar Casein Isolate in people with Amino Acid Change and Food Science, run by Nimble Science Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to presentation of the peptides in the small intestine by SIMBA/LIMBA capsule (time frame: From 0 minute to 240 minutes after ingestion of the capsule per intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.