Tolerance and Safety of an Oral Nutritional Supplement

Nestlé

Status: Terminated

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: MAG oil oral nutritional supplement (ONS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05100901

2104CLI

Details and patient eligibility

About

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

Full description

Primary objective is to assess whether the MAG oil (monoacylglycerol oil) containing study formula is well tolerated and safe when used as an ONS in healthy adults and adolescents.

Secondary objectives:

1. Describe the incidence and characteristics of possible gastrointestinal intolerance symptoms
2. Describe changes in 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 assess dietary adherence to the study protocol

Enrollment: 12 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Oral nutritional supplement

Experimental group

Description:

Oral nutritional supplement that contains MAG oil

Treatment:

Dietary Supplement: MAG oil oral nutritional supplement (ONS)