Clinical trial NCT05100901: Tolerance and Safety of an Oral Nutritional Supplement
Official title: Tolerance and Safety of an Oral Nutritional Supplement Containing Monoacylglycerol Oil (MAG Oil) as the Main Lipid Source in Healthy Adolescents and Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects who develop gastrointestinal intolerance leading to premature discontinuation
timeFrame: [ Time Frame: Day 2 to Day 15 ]
Secondary outcomes:
measure: Severity of gastrointestinal intolerance symptoms
timeFrame: [ Time Frame: Day 2 to Day 14 ]
measure: Severity of gastrointestinal intolerance symptoms
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Change in stool frequency
timeFrame: [ Time Frame: Day 1 to Day 15 ]
measure: Change in weight
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Change in triglycerides
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Change in cholesterol
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Change in fatty acids profile
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Changes full blood count
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Changes liver function
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Changes in renal function
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Changes in blood glucose
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Daily intake of study product
timeFrame: [ Time Frame: Day 1 to Day 15 ]
measure: Change in stool consistency
timeFrame: [ Time Frame: Day 1 to Day 15 ]
measure: Change in BMI
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Change in Fat soluble-vitamins profile
timeFrame: [ Time Frame: Day 1 and Day 15 ]
measure: Change in serum biochemistry parameters
timeFrame: [ Time Frame: Day 1 and Day 15 ]
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestlé CDU / Clinical Innovation Lab
Study officials:
References: