Tolerance and Safety of an Oral Nutritional Supplement

Study Overview
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Brief Summary
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This is an open label, non-randomized, interventional, single arm study.

Detailed Description
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Primary objective is to assess whether the MAG oil (monoacylglycerol oil) containing study formula is well tolerated and safe when used as an ONS in healthy adults and adolescents. Secondary objectives: Describe the incidence and characteristics of possible gastrointestinal intolerance symptoms Describe changes in stool characteristics, specifically stool frequency and consistency Describe changes in anthropometric parameters, particularly weight and body mass index (BMI) Describe changes in blood parameters of lipid metabolism Describe changes in hematological and serum biochemistry parameters Describe daily ONS intake and assess dietary adherence to the study protocol

Official Title
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Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents and Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: MAG oil oral nutritional supplement (ONS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers BMI range from >18 to <28 kg/m2 for adults with a minimum body weight of 45 kg BMI range between the 25th and 90th percentile according to the Swiss growth charts for adolescents with a minimum body weight of 40 kg Cohort 1: Adults aged 18+ years (6 males, 6 females) Cohort 2: Adolescents aged 12-17 years (6 males, 6 females) Deemed able to comply with study protocol for 2 weeks Able to obtain written informed consent from participants and /or legal guardians Exclusion Criteria: Pre-existing chronic medical or psychiatric conditions, as diagnosed by the treating physician Subjects taking dietary supplements (energy supplements, protein supplements) will be excluded. Subjects can continue taking vitamin or herbal supplements during the study period. Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease (IBD), diverticular disease, colon cancer, irritable bowel syndrome (IBS), history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average, or chronic or recurrent diarrhea with loose or watery bowel movements more than 3 times daily. Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment. Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment. Prior use of prescription medication(s), in particular antibiotics, antacids, laxatives or other medications impacting gastrointestinal transit time, within 8 weeks prior to enrolment. Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments. Known food allergy in particular cow's milk protein allergy (CMPA) or known hypersensitivity/intolerance to any other ingredients in the study product. Known alcohol or substance abuse; specifically, alcohol intake > 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. Pregnant or lactating women or having given birth in the past 6 months prior to enrolment. Family or hierarchical relationships with Clinical Innovation Lab staff.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral nutritional supplement<br>Oral nutritional supplement that contains MAG oil | Dietary Supplement: MAG oil oral nutritional supplement (ONS)<br>* The study product is suitable for use as an oral nutritional supplement (ONS).The study product contains MAG oil, hydrolyzed whey protein, simple carbohydrates, vitamins and minerals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who develop gastrointestinal intolerance leading to premature discontinuation | Number of subjects who develop gastrointestinal intolerance reported as adverse events related to the investigational product and leading to premature discontinuation of the study product, assessed by a daily questionnaire | [ Time Frame: Day 2 to Day 15 ] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of gastrointestinal intolerance symptoms | Visual analog scale from 0 (no symptom) to 10 (maximum severity) | [ Time Frame: Day 2 to Day 14 ] | 
| Severity of gastrointestinal intolerance symptoms | Gastrointestinal Symptom Rating Scale, each visit will asses symptoms over the past 7 days | [ Time Frame: Day 1 and Day 15 ] | 
| Change in stool frequency | Assessed by a questionnaire for stool frequency | [ Time Frame: Day 1 to Day 15 ] | 
| Change in weight |  | [ Time Frame: Day 1 and Day 15 ] | 
| Change in triglycerides |  | [ Time Frame: Day 1 and Day 15 ] | 
| Change in cholesterol |  | [ Time Frame: Day 1 and Day 15 ] | 
| Change in fatty acids profile |  | [ Time Frame: Day 1 and Day 15 ] | 
| Changes full blood count | Number of participants with changes in haematology measurements (erythrocyte count, thrombocyte count, haemoglobin, haematocrit, mean cell hemoglobin concertation) using immunoassays. | [ Time Frame: Day 1 and Day 15 ] | 
| Changes liver function | Number of participants with changes in liver function measurements (AST, ALT, ALP, GGT, albumin) using immunoassays | [ Time Frame: Day 1 and Day 15 ] | 
| Changes in renal function | Number of participants with changes in renal function measurements (urea, creatinine) using immunoassays | [ Time Frame: Day 1 and Day 15 ] | 
| Changes in blood glucose |  | [ Time Frame: Day 1 and Day 15 ] | 
| Daily intake of study product | Number of subjects adhering to daily intake of the study product from baseline to Day 15, assessed by a daily questionnaire | [ Time Frame: Day 1 to Day 15 ] | 
| Change in stool consistency | Assessed by the Bristol Stool Scale | [ Time Frame: Day 1 to Day 15 ] | 
| Change in BMI |  | [ Time Frame: Day 1 and Day 15 ] | 
| Change in Fat soluble-vitamins profile | Fat soluble-vitamins (A, D, E, K) | [ Time Frame: Day 1 and Day 15 ] | 
| Change in serum biochemistry parameters | Number of participants with changes in serum biochemistry (triglycerides, total protein, bilirubin total, bilirubin direct, sodium, potassium, calcium, phosphate, magnesium, chloride, CRP) using immunoassays | [ Time Frame: Day 1 and Day 15 ] |