Tolerance and Safety of an Oral Nutritional Supplement (Adolescent Cohort)

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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The primary objective is to assess whether the MAG oil-containing study formula is well tolerated and safe when used as an ONS in healthy adolescents. Hypothesis: The study product will be safe and well tolerated in healthy adolescents (as previously observed in adults). Secondary objectives: Describe the frequency and characteristics of possible gastrointestinal intolerance symptoms Describe 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 overall compliance

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

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 aged 12-17 years BMI range between the 10th and 90th percentile according to the Swiss growth charts with a minimum body weight of 40 kg. Deemed able to comply with study protocol for the study period Able to obtain written informed consent from participants and legally authorized representative(s) Exclusion Criteria: Pre-existing chronic medical or psychiatric conditions. History of a chronic gastrointestinal disorder (e.g., inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.), or chronic or recurrent gastrointestinal symptoms, including self-reported symptoms such as abdominal pain. Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment. History of chronic constipation (with passage of fewer than 3 spontaneous bowel movements per week on average or history of painful or hard bowel movements), OR chronic or intermittent diarrhea with loose or watery bowel movements ≥ 3 times per day. Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment. Prior use of prescription medication(s), in particular antibiotics, antiacids, laxatives, antidiarrheal agents or other medications impacting gastrointestinal transit time, within 3 weeks prior to enrolment. Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments. Subjects following a weight loss program including a low-carbohydrate or low-fat diet, ketogenic diet, intermittent fasting, or any other special diet. Known food allergy in particular cow's milk protein allergy or known/suspected hypersensitivity or intolerance to any other ingredients in the study product. Subjects experiencing gastrointestinal symptoms when consuming dairy products or avoiding dairy in their diet should not participate in the study. Subjects taking energy or protein supplements. Known alcohol or substance abuse. Pregnant or lactating females or having given birth in the past 6 months prior to enrolment. Pregnancy will be ruled out by performing a standard urine dipstick test to female participants of childbearing potential prior to enrolment. Family or hierarchical relationships with Clinical Innovation Lab staff

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who develop significant gastrointestinal adverse events (deemed probably related or related to study product as per investigator's opinion) leading to discontinuation of the study product and withdrawal from the study | Number of subjects who develop significant gastrointestinal adverse events leading to discontinuation of the study product and withdrawal from the study | Day 2 to Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of gastrointestinal intolerance symptoms | Individual gastrointestinal symptom scores assessed by the Visual Analogue Scale (VAS) tool from 0 (no symptom) to 10 (maximum severity) | Day 1 to Day 15 | 
| Severity of gastrointestinal intolerance symptoms | Individual gastrointestinal symptom scores assessed by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire from No discomfort at all (no discomfort) to Very severe discomfort (maximum discomfort) | Day 1 and Day 15 | 
| Change in stool frequency | Assessed by a questionnaire on daily number of stools | Day 1 to Day 15 | 
| Change in stool consistency | Assessed by Bristol Stool Scale from stool consistency A (Separate hard lumps, like nuts, hard to pass) to G (Watery, no solid pieces) | Day 1 to Day 15 | 
| Change in weight | Measured with a weight scale | Day 1 and Day 15 | 
| Change in BMI | Measured with a weight scale and size scale | Day 1 and Day 15 | 
| Changes in lipid profile in the blood | Triglycerides, cholesterol (total cholesterol, LDL cholesterol and HDL cholesterol) measured in plasma | Day 1 and Day 15 | 
| Changes in liver function tests in the blood | ALAT measured in plasma | Day 1 and Day 15 | 
| Changes in liver function tests in the blood | ASAT measured in plasma | Day 1 and Day 15 | 
| Changes in liver function tests in the blood | phosphatase alkaline measured in plasma | Day 1 and Day 15 | 
| Changes in liver function tests in the blood | Gamma glutamyl transferase measured in plasma | Day 1 and Day 15 | 
| Changes in liver function tests in the blood | Total and direct bilirubin measured in plasma | Day 1 and Day 15 | 
| Changes in liver function tests in the blood | Protein and albumin measured in plasma | Day 1 and Day 15 | 
| Changes in renal function tests in the blood | Urea, creatinine measured in plasma | Day 1 and Day 15 | 
| Changes in blood chemistry tests | C-Reactive Protein measured in serum | Day 1 and Day 15 | 
| Changes in blood chemistry tests | Glucose measured in serum | Day 1 and Day 15 | 
| Changes in blood chemistry tests | Sodium measured in serum | Day 1 and Day 15 | 
| Changes in blood chemistry tests | Potassium measured in serum | Day 1 and Day 15 | 
| Changes in blood chemistry tests | Calcium measured in serum | Day 1 and Day 15 | 
| Changes in blood chemistry tests | Phosphate measured in serum | Day 1 and Day 15 | 
| Changes in blood chemistry tests | Magnesium measured in serum | Day 1 and Day 15 | 
| Changes in blood chemistry tests | Chloride measured in serum | Day 1 and Day 15 | 
| Daily intake of study product | Number of participants adhering to daily intake of the study product assessed by a daily questionnaire | Day 1 to Day 15 | 
| Changes in full blood count | thrombocyte count | Day 1 and Day 15 | 
| Changes in full blood count | Erythrocyte count | Day 1 and Day 15 | 
| Changes in full blood count | haemoglobin measured in blood | Day 1 and Day 15 | 
| Changes in full blood count | haematocrit measured in blood | Day 1 and Day 15 | 
| Changes in full blood count | mean cell hemoglobin concentation measured in Blood | Day 1 and Day 15 | 
| Changes in fatty acids profile | Plasma and erythrocytes fatty acids profile | Day 1 and Day 15 | 
| Change in Vitamin A level | Change in serum Vitamin A | Day 1 and Day 15 | 
| Change in 25-hydroxy vitamin D level | Change in serum 25-hydroxy vitamin D | Day 1 and Day 15 | 
| Change in vitamin E level | Change in serum vitamin E | Day 1 and Day 15 | 
| Changes in Vitamin K level | change in international normalized ratio | Day 1 and Day 15 | 
| Changes in in fat-soluble vitamins | Vitamin E/cholesterol ratio measured in plasma | Day 1 and Day 15 |