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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: MAG oil oral nutritional supplement (ONS)

• Registration Number: NCT05923593
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This is an open label, non-randomized, interventional, single arm study.

Detailed Description

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:

1. Describe the frequency and characteristics of possible gastrointestinal intolerance symptoms

2. Describe 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 overall compliance

Study Timeline

• Study First Submitted: 2023-02-27
• Study Start: 2023-03-20
• Primary Completion: 2023-06-15
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-06-28
• Study Completion: 2023-08-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Healthy volunteers aged 12-17 years
2. BMI range between the 10th and 90th percentile according to the Swiss growth charts with a minimum body weight of 40 kg.
3. Deemed able to comply with study protocol for the study period
4. Able to obtain written informed consent from participants and legally authorized representative(s)

Exclusion Criteria

1. Pre-existing chronic medical or psychiatric conditions.
2. 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.
3. Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.
4. 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.
5. Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.
6. 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.
7. Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments.
8. Subjects following a weight loss program including a low-carbohydrate or low-fat diet, ketogenic diet, intermittent fasting, or any other special diet.
9. 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.
10. Subjects taking energy or protein supplements.
11. Known alcohol or substance abuse.
12. 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.
13. Family or hierarchical relationships with Clinical Innovation Lab staff

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral nutritional supplement	MAG oil oral nutritional supplement (ONS)	Oral nutritional supplement that contains MAG oil

Primary Outcome Measures

Name	Time	Method
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	Day 2 to Day 15	Number of subjects who develop significant gastrointestinal adverse events leading to discontinuation of the study product and withdrawal from the study

Secondary Outcome Measures

Name	Time	Method
Changes in blood chemistry tests	Day 1 and Day 15	Chloride measured in serum
Changes in Vitamin K level	Day 1 and Day 15	change in international normalized ratio
Change in weight	Day 1 and Day 15	Measured with a weight scale
Changes in lipid profile in the blood	Day 1 and Day 15	Triglycerides, cholesterol (total cholesterol, LDL cholesterol and HDL cholesterol) measured in plasma
Changes in renal function tests in the blood	Day 1 and Day 15	Urea, creatinine measured in plasma
Change in stool frequency	Day 1 to Day 15	Assessed by a questionnaire on daily number of stools
Change in BMI	Day 1 and Day 15	Measured with a weight scale and size scale
Change in Vitamin A level	Day 1 and Day 15	Change in serum Vitamin A
Changes in in fat-soluble vitamins	Day 1 and Day 15	Vitamin E/cholesterol ratio measured in plasma
Change in 25-hydroxy vitamin D level	Day 1 and Day 15	Change in serum 25-hydroxy vitamin D
Changes in liver function tests in the blood	Day 1 and Day 15	Protein and albumin measured in plasma
Daily intake of study product	Day 1 to Day 15	Number of participants adhering to daily intake of the study product assessed by a daily questionnaire
Changes in fatty acids profile	Day 1 and Day 15	Plasma and erythrocytes fatty acids profile
Change in vitamin E level	Day 1 and Day 15	Change in serum vitamin E
Severity of gastrointestinal intolerance symptoms	Day 1 and Day 15	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)
Change in stool consistency	Day 1 to Day 15	Assessed by Bristol Stool Scale from stool consistency A (Separate hard lumps, like nuts, hard to pass) to G (Watery, no solid pieces)
Changes in full blood count	Day 1 and Day 15	mean cell hemoglobin concentation measured in Blood

Trial Locations

Locations (1)

Clinical Innovation Lab.; 🇨🇭 Lausanne, Switzerland