HealthyNCT02241681
Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake
A study testing Peptamen 1.5 in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their metabolites have not been explored in details. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Peptamen 1.5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Jan 2015
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females
- Aged between 20 and 65 years old
- BMI in the normal range (18.5 to 25.0 kg/m2)
- Having signed his/her consent form
Who cannot join
- Clinically relevant digestive (including malabsorption or major surgery), renal, hepatic, pancreatic or metabolic disease (diabetes, hypo or hyperthyroidism, hypo or hypercorticism), as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, ALDL, AHDL, triglycerides, ASAT, ALTI, gamma GT, RCRP, creatinine)
- Medically diagnosed anemia based on a blood formula
- Food allergy, lactose intolerance and intolerance to milk proteins (anamnesis)
- Smokers (anamnesis)
- Pregnancy (anamnesis)
- Under corticoids or hormone (adrenal, thyroid) treatment
Show all 11Show fewer
- Alcohol intake: > 2 units a day (anamnesis)
- Consumption of illicit drugs (anamnesis)
- Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- Subject who cannot be expected to comply with the study procedures, including consuming the test product
- Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Metabolic unit, clinical Development unit, Nestec
Lausanne, 1000
About this study
Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their metabolites have not been explored in details.
This is an exploratory study aiming at determining the plasma level of MCT and their metabolites after oral intake of Peptamen.
Read the detailed description
20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single day.
Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline
- Conditions
- Healthy
- Being tested
- Peptamen 1.5
- Keywords
- Medium Chain Triglycerides, Medium Chain Triglycerides metabolites, Peptamen 1.5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptamen 1.5Dietary supplement
Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Peptamen 1.5 | Other | 500 mL of Peptamen 1.5 Receives: Dietary Supplement: Peptamen 1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of plasma Medium Chain Triglycerides (MCT)
Tmax, Cmax and AUC for MCTs as compared to baseline.
Measured: over 8 hours post intake
Secondary outcomes (1)
Measure of plasma MCT metabolites such as free fatty acids
Tmax, Cmax and AUC for MCT metabolites as compared to baseline
Measured: over 8 hours post intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, MD,PhD, Principal investigator, Metabolic Unit, Clinical Development Unit,Nestec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241681
- Sponsor's protocol ID
- 14.22.MET
- Status last verified
- Nov 2014
- First submitted
- 5 Sep 2014
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake
- ClinicalTrials.gov ID
- NCT02241681
- Acronym / sponsor ID
- 14.22.MET
- Conditions
- Healthy
- Keywords
- Medium Chain Triglycerides, Medium Chain Triglycerides metabolites, Peptamen 1.5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Sep 2014 (estimated)
- 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.
Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their metabolites have not been explored in details.
This is an exploratory study aiming at determining the plasma level of MCT and their metabolites after oral intake of Peptamen.
Detailed description
20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single day.
Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptamen 1.5 | Other | Dietary Supplement: Peptamen 1.5500 mL of Peptamen 1.5 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males and females
- Aged between 20 and 65 years old
- BMI in the normal range (18.5 to 25.0 kg/m2)
- Having signed his/her consent form
Key exclusion criteria (11 listed)
- Clinically relevant digestive (including malabsorption or major surgery), renal, hepatic, pancreatic or metabolic disease (diabetes, hypo or hyperthyroidism, hypo or hypercorticism), as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, ALDL, AHDL, triglycerides, ASAT, ALTI, gamma GT, RCRP, creatinine)
- Medically diagnosed anemia based on a blood formula
- Food allergy, lactose intolerance and intolerance to milk proteins (anamnesis)
- Smokers (anamnesis)
- Pregnancy (anamnesis)
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 |
|---|---|---|
| Peptamen 1.5Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours. | Dietary supplement | Peptamen 1.5 |
Primary outcome
Measure of plasma Medium Chain Triglycerides (MCT)
Time frame: over 8 hours post intake
Tmax, Cmax and AUC for MCTs as compared to baseline.
1 secondary outcome
Measure of plasma MCT metabolites such as free fatty acids
Time frame: over 8 hours post intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
Maurice Beaumont, MD,PhD principal investigator
Metabolic Unit, Clinical Development Unit,Nestec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptamen 1.5 in people with Healthy, 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 4 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: finished, as of the sponsor's last update on 26 Mar 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of plasma Medium Chain Triglycerides (MCT) (time frame: over 8 hours post intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2015.