HealthyBioLENCT02865486
Digestion of Biopolymer Based Lipid Emulsions
A study testing Lipid emulsion in people with Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that they differ in terms of acid stability, lipid droplet size and fat redispersibility. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lipid emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to Oct 2016
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-25 kg/m²
- Written informed consent
Who cannot join
- Donated blood within the last 3 months
- History of GI, cardiorespiratory (including arterial
- hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes
- Prior abdominal surgery other than uncomplicated appendectomy or hernia repair
- Requiring medication that might alter gut function, including calcium channel blockers, prokinetics, macrolide antibiotics
- Presence of metallic implants, devices or metallic foreign bodies
Show all 12Show fewer
- Pregnancy and lactation (female participants of child bearing age will receive a pregnancy test prior to study)
- Claustrophobia
- Regular smoking
- A history of drug or alcohol abuse
- A history of food allergies or intolerances
- Uncertainty about the willingness or ability of the participant to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Gastroenterology and Hepatology, University Hopsital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: The Effect of Biopolymer Based Lipid Emulsions on GI Function, GI Peptide Response and Satiation in Healthy Volunteers; a Randomized, Double Blind, Unbalanced Three-way Crossover Study
In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that they differ in terms of acid stability, lipid droplet size and fat redispersibility. The investigators hypothesize that the gastric emptying of fat will differ between the lipid emulsions.
An optional study day (visit 5) will be used to assess the degree of lipolysis in Lipid emulsion 5 (LE5) and Lipid emulsion 6 (LE6). This study day is a randomized, single blinded study.
Read the detailed description
The physical state of fat has been demonstrated to affect the rate of fat digestion. By engineering the physical properties of lipid emulsions the investigators are able to alter characteristics such as acid stability, lipid droplet size and fat redispersibility. These factors have been shown to modulate the physical state of fat in the stomach, the subsequent fat gastric emptying and digestion as well as satiation in healthy subjects. The investigators have recently developed a new series of lipid emulsions based on biopolymers. Preliminary animal studies have shown that these emulsions are able to effect GI physiology including GI peptide hormones and eating behavior. The primary aim of this work is to apply these biopolymer based lipid emulsions in healthy subjects and investigate their impact on fat digestion and satiation. A secondary aim is to develop an image analysis method that can quantify the heterogeneity of fat distribution within gastric content from the MRI data.
The participants (n=17) will be randomized at screening to receive 3 of the 4 lipid emulsions (LE).
On each of the three study days subjects will receive 200 mL of a lipid emulsion. MRI scans will be performed at regular intervals over a period of 3.5 h. Blood samples (for GI peptide hormone analysis) will also be taken at regular intervals until 5 h post LE ingestion. Further, 13C breath test samples will be obtained from participants every 10 min until 5 h post ingestion of LE. Throughout the entire 5 h study period participants will be asked to score their visceral sensation in relation to satiation. Once the technical section of the study is complete the participant will be provided with an ad libitum buffet from which they can consume as much or a little of the food options provided in the buffet.
Optional study day: After the main study is complete and the MRI data has been analyzed the study will be unblinded. This will enable the investigators to optimize an MR imaging and gastric content sampling schedule for LE5 and LE6. The participants (n=17) will be randomized and 10 subjects will then be given the opportunity to participate in the optional study day. The optional study day is single blinded and consists of 1 extra visit and is of a maximum 3 h duration. No bloods, breath test samples or visceral sensation scores will be taken. Subjects will arrive fasted and a nasogastric tube will be positioned. 200 mL of either LE5 or LE6 containing the 13C breath test marker will then be infused. MR imaging will continue at defined intervals until maximum of 3 h. In total five gastric content samples of 5 mL will be taken with the nasogastric tube.
- Conditions
- Healthy
- Being tested
- Lipid emulsion
- Keywords
- Gastric emptying, MRI, lipid emulsions, breath test, GI peptide hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid emulsionDietary supplement
1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 2.
Lipid emulsionDietary supplement
1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 3.
Lipid emulsionDietary supplement
1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 4.
| Study group | Role | What they receive |
|---|---|---|
| Lipid emulsion: visit 2 | Experimental | One of four randomly assigned lipid emulsions Receives: Dietary Supplement: Lipid emulsion |
| Lipid emulsion: visit 3 | Experimental | One of four randomly assigned lipid emulsions Receives: Dietary Supplement: Lipid emulsion |
| Lipid emulsion: visit 4 | Experimental | One of four randomly assigned lipid emulsions Receives: Dietary Supplement: Lipid emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of gastric fat volume emptying [ml/h]
Measured: up to 210 min
Secondary outcomes (12)
The gastric content emptying time constant [min]
Measured: up to 210 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of CCK [pmol/L].
cholecystokinin (CCK) [pmol/L].
Measured: up to 300 min
Half emptying time from 13CO2 breath test (BT_t50) [min]
Measured: up to 300 min
Half emptying time of MRI fat volume (MRI_t50) [min]
Measured: up to 210 min
Concordance correlation of MRI fat volume MRI_t50 and breath test BT_t50 [:]
Measured: up to 300 min
Total calorie load from food consumed at the ad libitum food buffet [kcal]
Measured: up to 330 min
Amount of calories consumed from healthy foods versus unhealthy food consumed from the ad libitum food buffet [%kcal]
Measured: up to 330 min
Fatty acid concentration in gastric aspirates in percentage [%]
Measured: up to 300 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of PYY [pg/mL]
peptide YY (PYY) [pg/mL]
Measured: up to 300 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of (GLP-1) [pg/mL]
glucagon-like peptide-1 (GLP-1) [pg/mL]
Measured: up to 300 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of BHB [µmol/L ]
ketone bodies β-hydroxybutyrate (BHB) [µmol/L ]
Measured: up to 300 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of triglycerides [mmol/L ]
tryglycerides [mmol/L ]
Measured: up to 300 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionOct 2016
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 University of ZurichThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Steingötter, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865486
- Sponsor's protocol ID
- BASEC 2015-00032
- Acronym
- BioLE
- Status last verified
- Oct 2016
- First submitted
- 14 Apr 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Biopolymer Based Lipid Emulsions on GI Function, GI Peptide Response and Satiation in Healthy Volunteers; a Randomized, Double Blind, Unbalanced Three-way Crossover Study
- ClinicalTrials.gov ID
- NCT02865486
- Acronym / sponsor ID
- BioLE / BASEC 2015-00032
- Conditions
- Healthy
- Keywords
- Gastric emptying, MRI, lipid emulsions, breath test, GI peptide hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Aug 2016 (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.
In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that they differ in terms of acid stability, lipid droplet size and fat redispersibility. The investigators hypothesize that the gastric emptying of fat will differ between the lipid emulsions.
An optional study day (visit 5) will be used to assess the degree of lipolysis in Lipid emulsion 5 (LE5) and Lipid emulsion 6 (LE6). This study day is a randomized, single blinded study.
Detailed description
The physical state of fat has been demonstrated to affect the rate of fat digestion. By engineering the physical properties of lipid emulsions the investigators are able to alter characteristics such as acid stability, lipid droplet size and fat redispersibility. These factors have been shown to modulate the physical state of fat in the stomach, the subsequent fat gastric emptying and digestion as well as satiation in healthy subjects. The investigators have recently developed a new series of lipid emulsions based on biopolymers. Preliminary animal studies have shown that these emulsions are able to effect GI physiology including GI peptide hormones and eating behavior. The primary aim of this work is to apply these biopolymer based lipid emulsions in healthy subjects and investigate their impact on fat digestion and satiation. A secondary aim is to develop an image analysis method that can quantify the heterogeneity of fat distribution within gastric content from the MRI data.
The participants (n=17) will be randomized at screening to receive 3 of the 4 lipid emulsions (LE).
On each of the three study days subjects will receive 200 mL of a lipid emulsion. MRI scans will be performed at regular intervals over a period of 3.5 h. Blood samples (for GI peptide hormone analysis) will also be taken at regular intervals until 5 h post LE ingestion. Further, 13C breath test samples will be obtained from participants every 10 min until 5 h post ingestion of LE. Throughout the entire 5 h study period participants will be asked to score their visceral sensation in relation to satiation. Once the technical section of the study is complete the participant will be provided with an ad libitum buffet from which they can consume as much or a little of the food options provided in the buffet.
Optional study day: After the main study is complete and the MRI data has been analyzed the study will be unblinded. This will enable the investigators to optimize an MR imaging and gastric content sampling schedule for LE5 and LE6. The participants (n=17) will be randomized and 10 subjects will then be given the opportunity to participate in the optional study day. The optional study day is single blinded and consists of 1 extra visit and is of a maximum 3 h duration. No bloods, breath test samples or visceral sensation scores will be taken. Subjects will arrive fasted and a nasogastric tube will be positioned. 200 mL of either LE5 or LE6 containing the 13C breath test marker will then be infused. MR imaging will continue at defined intervals until maximum of 3 h. In total five gastric content samples of 5 mL will be taken with the nasogastric tube.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lipid emulsion: visit 2 | Experimental | Dietary Supplement: Lipid emulsionOne of four randomly assigned lipid emulsions |
| Lipid emulsion: visit 3 | Experimental | Dietary Supplement: Lipid emulsionOne of four randomly assigned lipid emulsions |
| Lipid emulsion: visit 4 | Experimental | Dietary Supplement: Lipid emulsionOne of four randomly assigned lipid emulsions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18-25 kg/m²
- Written informed consent
Key exclusion criteria (12 listed)
- Donated blood within the last 3 months
- History of GI, cardiorespiratory (including arterial
- hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes
- Prior abdominal surgery other than uncomplicated appendectomy or hernia repair
- Requiring medication that might alter gut function, including calcium channel blockers, prokinetics, macrolide antibiotics
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 |
|---|---|---|
| Lipid emulsion1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 2. | Dietary supplement | Lipid emulsion: visit 2 |
| Lipid emulsion1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 3. | Dietary supplement | Lipid emulsion: visit 3 |
| Lipid emulsion1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 4. | Dietary supplement | Lipid emulsion: visit 4 |
Primary outcome
The rate of gastric fat volume emptying [ml/h]
Time frame: up to 210 min
12 secondary outcomes
The gastric content emptying time constant [min]
Time frame: up to 210 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of CCK [pmol/L].
Time frame: up to 300 min
Half emptying time from 13CO2 breath test (BT_t50) [min]
Time frame: up to 300 min
Half emptying time of MRI fat volume (MRI_t50) [min]
Time frame: up to 210 min
Concordance correlation of MRI fat volume MRI_t50 and breath test BT_t50 [:]
Time frame: up to 300 min
Total calorie load from food consumed at the ad libitum food buffet [kcal]
Time frame: up to 330 min
Amount of calories consumed from healthy foods versus unhealthy food consumed from the ad libitum food buffet [%kcal]
Time frame: up to 330 min
Fatty acid concentration in gastric aspirates in percentage [%]
Time frame: up to 300 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of PYY [pg/mL]
Time frame: up to 300 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of (GLP-1) [pg/mL]
Time frame: up to 300 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of BHB [µmol/L ]
Time frame: up to 300 min
Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of triglycerides [mmol/L ]
Time frame: up to 300 min
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 5 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Andreas Steingötter, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid emulsion in people with Healthy, run by University of Zurich 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 2 inclusion and 12 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 5 Oct 2016. 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?
The rate of gastric fat volume emptying [ml/h] (time frame: up to 210 min). 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 5 Oct 2016.