Tolerance and Safety of an Oral Nutritional Supplement

NCT05100901 | Terminated

• 1 other identifier: 2104CLI
• 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 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: Day 2 to Day 15 ]

Secondary Outcomes (16)

• Severity of gastrointestinal intolerance symptoms

  [ Time Frame: Day 2 to Day 14 ]

• Severity of gastrointestinal intolerance symptoms

  [ Time Frame: Day 1 and Day 15 ]

• Change in stool frequency

  [ Time Frame: Day 1 to Day 15 ]

• Change in weight

  [ Time Frame: Day 1 and Day 15 ]

• Change in triglycerides

  [ Time Frame: 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, hydrolyzed whey protein, simple carbohydrates, vitamins and minerals.

Oral nutritional supplement

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• BMI range from \>18 to \<28 kg/m2 for adults with a minimum body weight of 45 kg
• BMI range between the 25th and 90th percentile according to the Swiss growth charts for adolescents with a minimum body weight of 40 kg
• Cohort 1: Adults aged 18+ years (6 males, 6 females)
• Cohort 2: Adolescents aged 12-17 years (6 males, 6 females)
• Deemed able to comply with study protocol for 2 weeks
• Able to obtain written informed consent from participants and /or legal guardians

You may not qualify if:

• Pre-existing chronic medical or psychiatric conditions, as diagnosed by the treating physician
• Subjects taking dietary supplements (energy supplements, protein supplements) will be excluded. Subjects can continue taking vitamin or herbal supplements during the study period.
• Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease (IBD), diverticular disease, colon cancer, irritable bowel syndrome (IBS), history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average, or chronic or recurrent diarrhea with loose or watery bowel movements more than 3 times daily.
• Recent episode of an acute gastrointestinal illness with significant gastrointestinal symptoms in the 7 days prior to enrolment.
• Colonoscopy or other bowel cleansing procedures within 4 weeks prior to enrolment.
• Prior use of prescription medication(s), in particular antibiotics, antacids, laxatives or other medications impacting gastrointestinal transit time, within 8 weeks prior to enrolment.
• Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments.
• Known food allergy in particular cow's milk protein allergy (CMPA) or known hypersensitivity/intolerance to any other ingredients in the study product.
• Known alcohol or substance abuse; specifically, alcohol intake \> 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
• Pregnant or lactating women or having given birth in the past 6 months prior to enrolment.
• Family or hierarchical relationships with Clinical Innovation Lab staff.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Nestlé CDU / Clinical Innovation Lab

Lausanne, 1000, 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 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: August 16, 2021
• First Posted: October 29, 2021
• Study Start: September 24, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: April 5, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)