Clinical trial NCT05923593: Tolerance and Safety of an Oral Nutritional Supplement (Adolescent Cohort)
Official title: Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Day 2 to Day 15
Secondary outcomes:
measure: Severity of gastrointestinal intolerance symptoms
timeFrame: Day 1 to Day 15
measure: Severity of gastrointestinal intolerance symptoms
timeFrame: Day 1 and Day 15
measure: Change in stool frequency
timeFrame: Day 1 to Day 15
measure: Change in stool consistency
timeFrame: Day 1 to Day 15
measure: Change in weight
timeFrame: Day 1 and Day 15
measure: Change in BMI
timeFrame: Day 1 and Day 15
measure: Changes in lipid profile in the blood
timeFrame: Day 1 and Day 15
measure: Changes in liver function tests in the blood
timeFrame: Day 1 and Day 15
measure: Changes in liver function tests in the blood
timeFrame: Day 1 and Day 15
measure: Changes in liver function tests in the blood
timeFrame: Day 1 and Day 15
measure: Changes in liver function tests in the blood
timeFrame: Day 1 and Day 15
measure: Changes in liver function tests in the blood
timeFrame: Day 1 and Day 15
measure: Changes in liver function tests in the blood
timeFrame: Day 1 and Day 15
measure: Changes in renal function tests in the blood
timeFrame: Day 1 and Day 15
measure: Changes in blood chemistry tests
timeFrame: Day 1 and Day 15
measure: Changes in blood chemistry tests
timeFrame: Day 1 and Day 15
measure: Changes in blood chemistry tests
timeFrame: Day 1 and Day 15
measure: Changes in blood chemistry tests
timeFrame: Day 1 and Day 15
measure: Changes in blood chemistry tests
timeFrame: Day 1 and Day 15
measure: Changes in blood chemistry tests
timeFrame: Day 1 and Day 15
measure: Changes in blood chemistry tests
timeFrame: Day 1 and Day 15
measure: Changes in blood chemistry tests
timeFrame: Day 1 and Day 15
measure: Daily intake of study product
timeFrame: Day 1 to Day 15
measure: Changes in full blood count
timeFrame: Day 1 and Day 15
measure: Changes in full blood count
timeFrame: Day 1 and Day 15
measure: Changes in full blood count
timeFrame: Day 1 and Day 15
measure: Changes in full blood count
timeFrame: Day 1 and Day 15
measure: Changes in full blood count
timeFrame: Day 1 and Day 15
measure: Changes in fatty acids profile
timeFrame: Day 1 and Day 15
measure: Change in Vitamin A level
timeFrame: Day 1 and Day 15
measure: Change in 25-hydroxy vitamin D level
timeFrame: Day 1 and Day 15
measure: Change in vitamin E level
timeFrame: Day 1 and Day 15
measure: Changes in Vitamin K level
timeFrame: Day 1 and Day 15
measure: Changes in in fat-soluble vitamins
timeFrame: Day 1 and Day 15
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinical Innovation Lab.
Study officials:
affiliation: Neslté
name: Pamela Sun
role: PRINCIPAL_INVESTIGATOR
References: