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TerminatedNCT05100901Updated Apr 5, 2023

Tolerance and Safety of an Oral Nutritional Supplement

An interventional study of MAG oil oral nutritional supplement (ONS) in Healthy Volunteers, sponsored by Société des Produits Nestlé (SPN). Terminated at 1 site in Switzerland. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-05.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Other

Why this study was terminated
Adolescent cohort will be conducted as separate trial
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Oral nutritional supplement

    Oral nutritional supplement that contains MAG oil

    Dietary Supplement: MAG oil oral nutritional supplement (ONS)

Interventions

  • Dietary supplementMAG oil oral nutritional supplement (ONS)

    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.

06

What researchers measure

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: [ Time Frame: Day 2 to Day 15 ]

Secondary outcomes

  1. Severity of gastrointestinal intolerance symptoms

    Visual analog scale from 0 (no symptom) to 10 (maximum severity)

    Time frame: [ Time Frame: Day 2 to Day 14 ]

  2. Severity of gastrointestinal intolerance symptoms

    Gastrointestinal Symptom Rating Scale, each visit will asses symptoms over the past 7 days

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  3. Change in stool frequency

    Assessed by a questionnaire for stool frequency

    Time frame: [ Time Frame: Day 1 to Day 15 ]

  4. Change in weight

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  5. Change in triglycerides

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  6. Change in cholesterol

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  7. Change in fatty acids profile

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  8. Changes full blood count

    Number of participants with changes in haematology measurements (erythrocyte count, thrombocyte count, haemoglobin, haematocrit, mean cell hemoglobin concertation) using immunoassays.

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  9. Changes liver function

    Number of participants with changes in liver function measurements (AST, ALT, ALP, GGT, albumin) using immunoassays

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  10. Changes in renal function

    Number of participants with changes in renal function measurements (urea, creatinine) using immunoassays

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  11. Changes in blood glucose

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  12. Daily intake of study product

    Number of subjects adhering to daily intake of the study product from baseline to Day 15, assessed by a daily questionnaire

    Time frame: [ Time Frame: Day 1 to Day 15 ]

  13. Change in stool consistency

    Assessed by the Bristol Stool Scale

    Time frame: [ Time Frame: Day 1 to Day 15 ]

  14. Change in BMI

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  15. Change in Fat soluble-vitamins profile

    Fat soluble-vitamins (A, D, E, K)

    Time frame: [ Time Frame: Day 1 and Day 15 ]

  16. Change in serum biochemistry parameters

    Number of participants with changes in serum biochemistry (triglycerides, total protein, bilirubin total, bilirubin direct, sodium, potassium, calcium, phosphate, magnesium, chloride, CRP) using immunoassays

    Time frame: [ Time Frame: Day 1 and Day 15 ]

07

Study locations

1 site
  • Nestlé CDU / Clinical Innovation Lab
    Lausanne, 1000, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05100901
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Oct 29, 2021
Start date
Sep 24, 2021
Primary completion
Oct 15, 2021
Completion
Oct 15, 2021
Last update
Apr 5, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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