This is an open label, non-randomized, interventional, single arm study.
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: 1. Describe the incidence and characteristics of possible gastrointestinal intolerance symptoms 2. Describe changes in stool characteristics, specifically stool frequency and consistency 3. Describe changes in anthropometric parameters, particularly weight and body mass index (BMI) 4. Describe changes in blood parameters of lipid metabolism 5. Describe changes in hematological and serum biochemistry parameters 6. Describe daily ONS intake and assess dietary adherence to the study protocol
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
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.
Nestlé CDU / Clinical Innovation Lab
Lausanne, Switzerland
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: [ Time Frame: Day 2 to Day 15 ]
Severity of gastrointestinal intolerance symptoms
Visual analog scale from 0 (no symptom) to 10 (maximum severity)
Time frame: [ 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: [ Time Frame: Day 1 and Day 15 ]
Change in stool frequency
Assessed by a questionnaire for stool frequency
Time frame: [ Time Frame: Day 1 to Day 15 ]
Change in weight
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in triglycerides
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in cholesterol
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in fatty acids profile
Time frame: [ 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.
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Time frame: [ 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: [ 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: [ Time Frame: Day 1 and Day 15 ]
Changes in blood glucose
Time frame: [ 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: [ Time Frame: Day 1 to Day 15 ]
Change in stool consistency
Assessed by the Bristol Stool Scale
Time frame: [ Time Frame: Day 1 to Day 15 ]
Change in BMI
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in Fat soluble-vitamins profile
Fat soluble-vitamins (A, D, E, K)
Time frame: [ 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: [ Time Frame: Day 1 and Day 15 ]