Healthy VolunteersNCT02800538
The Effects of Intragastric Administration of Nutrients on Executive Control in Healthy Subjects.
A study testing intragastric infusion of nutrient in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The previous research by one of our members in the research team (H. Miller) suggests a possible influence of oral nutrients intake of certain fat or carbohydrates (glucose, fructose) on executive control. On the other hand, another previous study from our group (L. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- intragastric infusion of nutrient
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- 25 May 2015to 27 Jun 2017
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- N = 26 These numbers are based on a power calculation for a repeated measures ANOVA with one within-subject factor using Gpower software version 3.1.7 (http://www.psycho.uni-duesseldorf.de/abteilungen/aap/gpower3), indicating that these sample sizes are needed to achieve 90% power to detect a medium-sized effect (f = 0.25).
- Men \& women
- Age: >17 years
- 20 ≤ BMI ≤ 25
- Of good mental and physical health
Who cannot join
- Participants with one or more of self-reported points below will be excluded:
- History of, or current presence of:
- Psychiatric disorders (e.g., anxiety disorders, somatization disorder, eating disorders, depression, substance-related disorders alcohol abuse or dependence etc.)
- Abnormal eating behavior (including restraint and emotional eating)
- Abdominal/thoracic surgery
- Neurological, endocrine or digestive related disorders
Show all 16Show fewer
- Head trauma with loss of consciousness
- Other serious medical conditions
- Use of any drugs, including cannabis, during the past 6 months
- Current presence of:
- Pregnancy
- Medication use that affects the function of the gastrointestinal tract and/or affects the nervous system, psychotropics or painkillers
- A recent accident or surgery that has not fully recovered
- Other
- Smoking
- Women not taking hormonal contraception
Trial locations and contacts
1 site in 1 country.
About this study
The previous research by one of our members in the research team (H. Miller) suggests a possible influence of oral nutrients intake of certain fat or carbohydrates (glucose, fructose) on executive control. On the other hand, another previous study from our group (L. Van Oudenhove) suggests a subliminal influence of intragastric administration of fatty acids on subjective and neural responses to negative emotion induction. The purpose of this study therefore is to examine the effect of intragastric administration of certain fatty acids and carbohydrates on executive control in healthy volunteers.
Therefore one group of healthy volunteers are invited to the study. The participants will be randomly administered one of the three fatty acid emulsions or placebo via a nasogastric tube in each of the visits. After the exposure period, participants will use a computer to perform there different tasks to measure executive control. During each study visit, regular measurements of emotion, physical sensations, as well as blood glucose will be assessed. Furthermore, an electrocardiogram will be continuously recorded for the calculation of vagal function.
- Conditions
- Healthy Volunteers
- Being tested
- intragastric infusion of nutrient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intragastric infusion of nutrientDietary supplement
Intragastric infusion of nutrient that can be widely found in daily food or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Lauric acid | Experimental | the nutrient that can be widely found in daily food. Receives: Dietary Supplement: intragastric infusion of nutrient |
| Palmitic acid | Experimental | the nutrient that can be widely found in daily food. Receives: Dietary Supplement: intragastric infusion of nutrient |
| Capric acid | Experimental | the nutrient that can be widely found in daily food. Receives: Dietary Supplement: intragastric infusion of nutrient |
| Saline | Placebo comparator | physiological salt water Receives: Dietary Supplement: intragastric infusion of nutrient |
What is being measured
The primary outcome is the main question the study is designed to answer.
trial making task
Participants will be required to connect a set of 25 numbered dots in numerical order as fast as possible while still maintaining accuracy.
Measured: 60 min after intervention
digital span task
Participants will be presented with a series of single-digit numbers and required to remember them. After the series has been presented the participants will need to indicate the numbers presented.
Measured: 60 min after intervention
memory task
A list of 15 words that are matched for frequency, concreteness, and imagery will be presented to the participant via a computer monitor at the rate of one every 2 sec. Afterwards they will be given 60 sec to write down as many words as they are able to recall from the list. Accuracy and errors will be recorded.
Measured: 60 min after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start25 May 2015
- Primary completion27 Jun 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800538
- Sponsor's protocol ID
- S56123
- Status last verified
- Nov 2016
- First submitted
- 6 Jun 2016
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intragastric Administration of Nutrients on Executive Control in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02800538
- Acronym / sponsor ID
- S56123
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 25 May 2015 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 15 Jun 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.
The previous research by one of our members in the research team (H. Miller) suggests a possible influence of oral nutrients intake of certain fat or carbohydrates (glucose, fructose) on executive control. On the other hand, another previous study from our group (L. Van Oudenhove) suggests a subliminal influence of intragastric administration of fatty acids on subjective and neural responses to negative emotion induction. The purpose of this study therefore is to examine the effect of intragastric administration of certain fatty acids and carbohydrates on executive control in healthy volunteers.
Therefore one group of healthy volunteers are invited to the study. The participants will be randomly administered one of the three fatty acid emulsions or placebo via a nasogastric tube in each of the visits. After the exposure period, participants will use a computer to perform there different tasks to measure executive control. During each study visit, regular measurements of emotion, physical sensations, as well as blood glucose will be assessed. Furthermore, an electrocardiogram will be continuously recorded for the calculation of vagal function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lauric acid | Experimental | Dietary Supplement: intragastric infusion of nutrientthe nutrient that can be widely found in daily food. |
| Palmitic acid | Experimental | Dietary Supplement: intragastric infusion of nutrientthe nutrient that can be widely found in daily food. |
| Capric acid | Experimental | Dietary Supplement: intragastric infusion of nutrientthe nutrient that can be widely found in daily food. |
| Saline | Placebo comparator | Dietary Supplement: intragastric infusion of nutrientphysiological salt water |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- N = 26 These numbers are based on a power calculation for a repeated measures ANOVA with one within-subject factor using Gpower software version 3.1.7 (http://www.psycho.uni-duesseldorf.de/abteilungen/aap/gpower3), indicating that these sample sizes are needed to achieve 90% power to detect a medium-sized effect (f = 0.25).
- Men \& women
- Age: >17 years
- 20 ≤ BMI ≤ 25
- Of good mental and physical health
Key exclusion criteria (16 listed)
- History of, or current presence of:
- Current presence of:
- Other
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 |
|---|---|---|
| intragastric infusion of nutrientIntragastric infusion of nutrient that can be widely found in daily food or placebo. | Dietary supplement | Capric acid, Lauric acid, Palmitic acid, Saline |
Primary outcome
trial making task
Time frame: 60 min after intervention
Participants will be required to connect a set of 25 numbered dots in numerical order as fast as possible while still maintaining accuracy.
digital span task
Time frame: 60 min after intervention
Participants will be presented with a series of single-digit numbers and required to remember them. After the series has been presented the participants will need to indicate the numbers presented.
memory task
Time frame: 60 min after intervention
A list of 15 words that are matched for frequency, concreteness, and imagery will be presented to the participant via a computer monitor at the rate of one every 2 sec. Afterwards they will be given 60 sec to write down as many words as they are able to recall from the list. Accuracy and errors will be recorded.
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 11 Sep 2017.
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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 intragastric infusion of nutrient in people with Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 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 11 Sep 2017. 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 Belgium. 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?
trial making task (time frame: 60 min after intervention). The study lists 3 primary outcomes in all. 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 11 Sep 2017.