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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
20
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 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.
Cumming School of Medicine
Calgary, Alberta, Canada
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),
Time frame: From 0 minute to 240 minutes after ingestion of the capsule per intervention period
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),
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From 0 minute to 240 minutes after ingestion of the capsule per intervention period
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