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Completed NCT06394687

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

Conditions: Amino Acid Change, Food Science, Nutrition, Digestion Rate, Microtia

Sex: All
Ages: 20 Years – 55 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 24
Sponsor: Nimble Science Ltd.

Location: Cumming School of Medicine Calgary Alberta

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.

Eligibility Criteria

Inclusion Criteria: 1. Aged 20 to 55 years old at inclusion in the study, both female and male subjects. 2. Signed Informed Consent; willing \& able to comply with study procedures. 3. Willing to maintain their diet and physical activity levels during the study. 4. Able to swallow a size-00 capsule (23mm length). 5. No planned change in diet or medical interventions during the study duration Exclusion Criteria: 1. 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. 2. 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. 3. History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction. 4. Known history abdominal radiation treatment. 5. 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. 6. Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome. 7. 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. 8. Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable). 9. History or diagnosis of immunological or infectious disease (hepatitis, tuberculosis, HIV, Parkinson's). 10. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration. 11. Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed. 12. Consumption of probiotic or prebiotic supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed. 13. Any prior Fecal Microbiota Transplantation. 14. Colon cleanses/bowel prep for 2 weeks 15. Pregnant or breastfeeding. 16. Planning to become pregnant. 17. Alcohol or drug abuse. 18. Milk or soy allergy 19. Lactose intolerant 20. Vegan diet

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06394687). StuddyBuddy aggregates publicly available trial information.