The Digestion of Protein Powders in Healthy Participants Using SIMBA and LIMBA Capsule (NCT06394687) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Digestion of Protein Powders in Healthy Participants Using SIMBA and LIMBA Capsule
Canada20 participantsStarted 2024-11-10
Plain-language 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.
Who can participate
Age range20 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Time to presentation of the peptides in the small intestine by SIMBA/LIMBA capsule
Timeframe: From 0 minute to 240 minutes after ingestion of the capsule per intervention period
✕. 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).