Phase
Condition
N/ATreatment
Micellar Casein Isolate
Milk Protein Concentrate
Clinical Study ID
Ages 20-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
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 theopinion of the investigator, would adversely affect study safety or outcome.
Prior gastrointestinal disease, surgery, or radiation treatment which, in theInvestigator's opinion, would lead to intestinal structuring or obstruction with arisk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis,cancer diagnosis or previous esophageal, gastric, small intestinal, or colonicsurgery. Appendectomy or cholecystectomy more than 3 months before the screeningvisit is acceptable.
History of known structural gastrointestinal abnormalities such as structures orfistulas leading to mechanical obstruction.
Known history abdominal radiation treatment.
Use of any medications in the week prior to the screening study visit, unless partof regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, GLP-1 analogues); laxative use isallowed if it is kept unchanged in the week prior to the study visit. Proton pumpinhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respectedbefore swallowing the SIMBA/LIMBA capsules and PPI treatment is resumed only 4 hoursthereafter.
Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction,systemic sclerosis, Ogilvie's syndrome.
Any significant gastrointestinal, heart, liver, lung, kidney, blood, endocrine ornervous system disease, which in the opinion of the investigator, would adverselyaffect study safety or outcome.
Cancer diagnosis or treatment within the past year (non-melanoma skin cancers areacceptable).
History or diagnosis of immunological or infectious disease (hepatitis,tuberculosis, HIV, Parkinson's).
History of oropharyngeal dysphagia, or other swallowing disorder with a risk ofcapsule aspiration.
Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potentialparticipants 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
Study Design
Study Description
Connect with a study center
Cumming School of Medicine
Calgary, Alberta T2N 4N1
CanadaActive - Recruiting
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