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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05923593
• Other study ID #: 2214NR
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 30, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• MAG oil oral nutritional supplement (ONS)
The study product is suitable for use as an oral nutritional supplement (ONS).The study product contains MAG oil.

Locations

Country	Name	City	State
Switzerland	Clinical Innovation Lab.	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in stool frequency	Assessed by a questionnaire on daily number of stools	Day 1 to Day 15
Secondary	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
Secondary	Change in weight	Measured with a weight scale	Day 1 and Day 15
Secondary	Change in BMI	Measured with a weight scale and size scale	Day 1 and Day 15
Secondary	Changes in lipid profile in the blood	Triglycerides, cholesterol (total cholesterol, LDL cholesterol and HDL cholesterol) measured in plasma	Day 1 and Day 15
Secondary	Changes in liver function tests in the blood	ALAT measured in plasma	Day 1 and Day 15
Secondary	Changes in liver function tests in the blood	ASAT measured in plasma	Day 1 and Day 15
Secondary	Changes in liver function tests in the blood	phosphatase alkaline measured in plasma	Day 1 and Day 15
Secondary	Changes in liver function tests in the blood	Gamma glutamyl transferase measured in plasma	Day 1 and Day 15
Secondary	Changes in liver function tests in the blood	Total and direct bilirubin measured in plasma	Day 1 and Day 15
Secondary	Changes in liver function tests in the blood	Protein and albumin measured in plasma	Day 1 and Day 15
Secondary	Changes in renal function tests in the blood	Urea, creatinine measured in plasma	Day 1 and Day 15
Secondary	Changes in blood chemistry tests	C-Reactive Protein measured in serum	Day 1 and Day 15
Secondary	Changes in blood chemistry tests	Glucose measured in serum	Day 1 and Day 15
Secondary	Changes in blood chemistry tests	Sodium measured in serum	Day 1 and Day 15
Secondary	Changes in blood chemistry tests	Potassium measured in serum	Day 1 and Day 15
Secondary	Changes in blood chemistry tests	Calcium measured in serum	Day 1 and Day 15
Secondary	Changes in blood chemistry tests	Phosphate measured in serum	Day 1 and Day 15
Secondary	Changes in blood chemistry tests	Magnesium measured in serum	Day 1 and Day 15
Secondary	Changes in blood chemistry tests	Chloride measured in serum	Day 1 and Day 15
Secondary	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
Secondary	Changes in full blood count	thrombocyte count	Day 1 and Day 15
Secondary	Changes in full blood count	Erythrocyte count	Day 1 and Day 15
Secondary	Changes in full blood count	haemoglobin measured in blood	Day 1 and Day 15
Secondary	Changes in full blood count	haematocrit measured in blood	Day 1 and Day 15
Secondary	Changes in full blood count	mean cell hemoglobin concentation measured in Blood	Day 1 and Day 15
Secondary	Changes in fatty acids profile	Plasma and erythrocytes fatty acids profile	Day 1 and Day 15
Secondary	Change in Vitamin A level	Change in serum Vitamin A	Day 1 and Day 15
Secondary	Change in 25-hydroxy vitamin D level	Change in serum 25-hydroxy vitamin D	Day 1 and Day 15
Secondary	Change in vitamin E level	Change in serum vitamin E	Day 1 and Day 15
Secondary	Changes in Vitamin K level	change in international normalized ratio	Day 1 and Day 15
Secondary	Changes in in fat-soluble vitamins	Vitamin E/cholesterol ratio measured in plasma	Day 1 and Day 15