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

NCT05923593 | Completed

• 1 other identifier: 2214NR
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (34)

• Severity of gastrointestinal intolerance symptoms

  Day 1 to Day 15

• Severity of gastrointestinal intolerance symptoms

  Day 1 and Day 15

• Change in stool frequency

  Day 1 to Day 15

• Change in stool consistency

  Day 1 to Day 15

• Change in weight

  Day 1 and Day 15

Study Arms (1)

Oral nutritional supplement

EXPERIMENTAL

Oral nutritional supplement that contains MAG oil

Dietary Supplement: MAG oil oral nutritional supplement (ONS)

Interventions

MAG oil oral nutritional supplement (ONS) DIETARY_SUPPLEMENT

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

Oral nutritional supplement

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Innovation Lab.

Lausanne, Switzerland

Location

Related Publications (1)

• Zemrani B, Krattinger LF, Giuffrida F, Corthesy J, Ran-Ressler RR, Benyacoub J. Safety and tolerability of Monoacylglycerol-rich oil as a novel predigested dietary fat source of an enteral formula in healthy adults and adolescents: Two single-arm, open-label studies. Clin Nutr ESPEN. 2025 Feb;65:339-347. doi: 10.1016/j.clnesp.2024.12.014. Epub 2024 Dec 15.

  PMID: 39681164 DERIVED

Study Officials

• Pamela Sun

  Neslté

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: June 28, 2023
• Study Start: March 20, 2023
• Primary Completion: June 15, 2023
• Study Completion: August 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

CH (1)