Healthy VolunteersNCT05100901
Tolerance and Safety of an Oral Nutritional Supplement
A study testing MAG oil oral nutritional supplement (ONS) in people with Healthy Volunteers, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This is an open label, non-randomized, interventional, single arm study. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MAG oil oral nutritional supplement (ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Sep 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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:
- Describe the incidence and characteristics of possible gastrointestinal intolerance symptoms
- Describe changes in stool characteristics, specifically stool frequency and consistency
- Describe changes in anthropometric parameters, particularly weight and body mass index (BMI)
- Describe changes in blood parameters of lipid metabolism
- Describe changes in hematological and serum biochemistry parameters
- Describe daily ONS intake and assess dietary adherence to the study protocol
- Conditions
- Healthy Volunteers
- Being tested
- MAG oil oral nutritional supplement (ONS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral nutritional supplement | Experimental | Oral nutritional supplement that contains MAG oil Receives: Dietary Supplement: MAG oil oral nutritional supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [ Time Frame: Day 2 to Day 15 ]
Secondary outcomes (16)
Severity of gastrointestinal intolerance symptoms
Visual analog scale from 0 (no symptom) to 10 (maximum severity)
Measured: [ Time Frame: Day 2 to Day 14 ]
Severity of gastrointestinal intolerance symptoms
Gastrointestinal Symptom Rating Scale, each visit will asses symptoms over the past 7 days
Measured: [ Time Frame: Day 1 and Day 15 ]
Change in stool frequency
Assessed by a questionnaire for stool frequency
Measured: [ Time Frame: Day 1 to Day 15 ]
Change in weight
Measured: [ Time Frame: Day 1 and Day 15 ]
Change in triglycerides
Measured: [ Time Frame: Day 1 and Day 15 ]
Change in cholesterol
Measured: [ Time Frame: Day 1 and Day 15 ]
Change in fatty acids profile
Measured: [ Time Frame: Day 1 and Day 15 ]
Changes full blood count
Number of participants with changes in haematology measurements (erythrocyte count, thrombocyte count, haemoglobin, haematocrit, mean cell hemoglobin concertation) using immunoassays.
Measured: [ Time Frame: Day 1 and Day 15 ]
Changes liver function
Number of participants with changes in liver function measurements (AST, ALT, ALP, GGT, albumin) using immunoassays
Measured: [ Time Frame: Day 1 and Day 15 ]
Changes in renal function
Number of participants with changes in renal function measurements (urea, creatinine) using immunoassays
Measured: [ Time Frame: Day 1 and Day 15 ]
Changes in blood glucose
Measured: [ Time Frame: Day 1 and Day 15 ]
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
Measured: [ Time Frame: Day 1 to Day 15 ]
Change in stool consistency
Assessed by the Bristol Stool Scale
Measured: [ Time Frame: Day 1 to Day 15 ]
Change in BMI
Measured: [ Time Frame: Day 1 and Day 15 ]
Change in Fat soluble-vitamins profile
Fat soluble-vitamins (A, D, E, K)
Measured: [ Time Frame: Day 1 and Day 15 ]
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
Measured: [ Time Frame: Day 1 and Day 15 ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start24 Sep 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Why it stopped: Adolescent cohort will be conducted as separate trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100901
- Sponsor's protocol ID
- 2104CLI
- Status last verified
- Jun 2022
- First submitted
- 16 Aug 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39681164
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05100901
- Acronym / sponsor ID
- 2104CLI
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adolescent cohort will be conducted as separate trial
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Describe the incidence and characteristics of possible gastrointestinal intolerance symptoms
- Describe changes in stool characteristics, specifically stool frequency and consistency
- Describe changes in anthropometric parameters, particularly weight and body mass index (BMI)
- Describe changes in blood parameters of lipid metabolism
- Describe changes in hematological and serum biochemistry parameters
- Describe daily ONS intake and assess dietary adherence to the study protocol
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral nutritional supplement | Experimental | Dietary Supplement: MAG oil oral nutritional supplement (ONS)Oral nutritional supplement that contains MAG oil |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAG 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. | Dietary supplement | Oral nutritional supplement |
Primary outcome
Number of subjects who develop gastrointestinal intolerance leading to premature discontinuation
Time frame: [ Time Frame: Day 2 to Day 15 ]
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
16 secondary outcomes
Severity of gastrointestinal intolerance symptoms
Time frame: [ Time Frame: Day 2 to Day 14 ]
Severity of gastrointestinal intolerance symptoms
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in stool frequency
Time frame: [ Time Frame: Day 1 to Day 15 ]
Change in weight
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in triglycerides
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in cholesterol
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in fatty acids profile
Time frame: [ Time Frame: Day 1 and Day 15 ]
Changes full blood count
Time frame: [ Time Frame: Day 1 and Day 15 ]
Changes liver function
Time frame: [ Time Frame: Day 1 and Day 15 ]
Changes in renal function
Time frame: [ Time Frame: Day 1 and Day 15 ]
Changes in blood glucose
Time frame: [ Time Frame: Day 1 and Day 15 ]
Daily intake of study product
Time frame: [ Time Frame: Day 1 to Day 15 ]
Change in stool consistency
Time frame: [ Time Frame: Day 1 to Day 15 ]
Change in BMI
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in Fat soluble-vitamins profile
Time frame: [ Time Frame: Day 1 and Day 15 ]
Change in serum biochemistry parameters
Time frame: [ Time Frame: Day 1 and Day 15 ]
Results and safety
The study was stopped early (reason given: Adolescent cohort will be conducted as separate trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 39681164Zemrani 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAG oil oral nutritional supplement (ONS) in people with Healthy Volunteers, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Adolescent cohort will be conducted as separate trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who develop gastrointestinal intolerance leading to premature discontinuation (time frame: [ Time Frame: Day 2 to Day 15 ]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.