HealthyNCT01727583
Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients
A study testing meal intake in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This pilot study is aimed at assessing the acute effect of several combinations of lipids differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1 secretion in healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- meal intake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Nov 2013
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI : 19 - 24.9 kg.m-2
- Normal fasting glycemia
- Having obtained his informed consent.
Who cannot join
- Gastro-intestinal disease (ulcer), pancreatic disease, hepatic disease, metabolic diseases / disorders (diabetes, dyslipidemia), renal disease, cardiovascular disease (arterial hypertension), as determined by the medical screening visit and a blood analysis.
- Have had a gastrointestinal surgery (with the exception of appendices resection).
- Malabsorption disorders
- Lactose intolerance
- Significant weight loss during the past three months (more than 5% of initial weight)
- Have a regular consumption of medication
Show all 16Show fewer
- Regular supplements (vitamins and minerals) intake during the previous month
- Have an alcohol intake: > 2 units a day
- Smoker (more than 2 cigarettes a day)
- Illicit substances intake, as stated on the medical screening questionnaire
- Allergy to any food or medication
- Anaemia defined by a number of erythrocytes or hemoglobin Hb or hematocrit Ht which are inferior to laboratory normal ranges
- Having given blood in the past three months or willing to give blood in the 3 months following the completion of the study
- Intense physical activity > 3 hours per week
- Currently participating or having participated in another clinical trial during the past month.
- Volunteer who cannot be expected to comply with the protocol, including consuming rapidly the study products, chronic medication intake
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study is aimed at assessing the acute effect of several combinations of lipids differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1 secretion in healthy subjects.
Read the detailed description
In this study, the investigators aim to investigate the effect of various lipid types on GLP-2 and GLP-1 secretion. This will allow to determine the importance of lipids in nutritional solutions. Moreover, this will allow us to assess whether existing clinical formulas can be improved in order to stimulate GLP-2 and accelerate intestinal recovery.
- Conditions
- Healthy
- Being tested
- meal intake, Placebo
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meal intakeDietary supplement
Intake of meals characterized by lipid composition
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Lipid 1 | Active comparator | Meal intake Receives: Dietary Supplement: meal intake |
| Lipid-free | Placebo comparator | Maltodextrine + proteins Receives: Dietary Supplement: Placebo |
| Lipid 2 | Active comparator | Meal intake Receives: Dietary Supplement: meal intake |
| Lipid 3 | Active comparator | Meal intake Receives: Dietary Supplement: meal intake |
| Lipid 4 | Active comparator | meal intake Receives: Dietary Supplement: meal intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-2 and GLP-1 kinetics
GLP-2 and GLP-1 are measured using Elisa
Measured: changes from baseline to 4 hours following meal intake
Secondary outcomes (1)
Intestinal and metabolic hormones
Those hormones will be measured based on enzymatic technics
Measured: Changes from baseline to 4 hours following meal intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionNov 2013
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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 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, Principal investigator, Nestlé / CDU / Metabolic Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727583
- Sponsor's protocol ID
- 12.10.MET
- Status last verified
- Nov 2013
- First submitted
- 12 Nov 2012
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients
- ClinicalTrials.gov ID
- NCT01727583
- Acronym / sponsor ID
- 12.10.MET
- Conditions
- Healthy
- Keywords
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Nov 2012 (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.
This pilot study is aimed at assessing the acute effect of several combinations of lipids differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1 secretion in healthy subjects.
Detailed description
In this study, the investigators aim to investigate the effect of various lipid types on GLP-2 and GLP-1 secretion. This will allow to determine the importance of lipids in nutritional solutions. Moreover, this will allow us to assess whether existing clinical formulas can be improved in order to stimulate GLP-2 and accelerate intestinal recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lipid 1 | Active comparator | Dietary Supplement: meal intakeMeal intake |
| Lipid-free | Placebo comparator | Dietary Supplement: PlaceboMaltodextrine + proteins |
| Lipid 2 | Active comparator | Dietary Supplement: meal intakeMeal intake |
| Lipid 3 | Active comparator | Dietary Supplement: meal intakeMeal intake |
| Lipid 4 | Active comparator | Dietary Supplement: meal intakemeal intake |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI : 19 - 24.9 kg.m-2
- Normal fasting glycemia
- Having obtained his informed consent.
Key exclusion criteria (16 listed)
- Gastro-intestinal disease (ulcer), pancreatic disease, hepatic disease, metabolic diseases / disorders (diabetes, dyslipidemia), renal disease, cardiovascular disease (arterial hypertension), as determined by the medical screening visit and a blood analysis.
- Have had a gastrointestinal surgery (with the exception of appendices resection).
- Malabsorption disorders
- Lactose intolerance
- Significant weight loss during the past three months (more than 5% of initial weight)
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 |
|---|---|---|
| meal intakeIntake of meals characterized by lipid composition | Dietary supplement | Lipid 1, Lipid 2, Lipid 3, Lipid 4 |
| Placebo | Dietary supplement | Lipid-free |
Primary outcome
GLP-2 and GLP-1 kinetics
Time frame: changes from baseline to 4 hours following meal intake
GLP-2 and GLP-1 are measured using Elisa
1 secondary outcome
Intestinal and metabolic hormones
Time frame: Changes from baseline to 4 hours following meal 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 8 Nov 2013.
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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 principal investigator
Nestlé / CDU / Metabolic Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meal intake 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 3 inclusion and 16 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 8 Nov 2013. 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. Some participants in this study may receive a placebo. 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?
GLP-2 and GLP-1 kinetics (time frame: changes from baseline to 4 hours following meal 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 8 Nov 2013.