HealthyNCT03383250
Metabolomic Response to Meal Ingestion
A study testing Normal meal in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial summary
The investigators have recently shown that postprandial sensations correlate with changes in circulating metabolites after a meal ingestion; however this phenomenon was demonstrated with a meal load up to the level of tolerance which involved an unpleasant fullness sensation. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Normal meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2014to 15 Oct 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non obese
Who cannot join
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
- alcohol abuse
- psychological disorders
- eating disorders
About this study
Official title: Factors to Determine the Responses to Meal Ingestion: Circulating Metabolites
The investigators have recently shown that postprandial sensations correlate with changes in circulating metabolites after a meal ingestion; however this phenomenon was demonstrated with a meal load up to the level of tolerance which involved an unpleasant fullness sensation. The aim of the present study is to determine changes in circulating metabolites of a satiating pleasurable meal. Healthy men (n = 32) will be evaluated after a 5 h fast. Perception measurements and blood samples will be taken before and 20 minutes after ingestion of a palatable probe meal (juice and warm ham and cheese sandwich, total 300 ml, 440 kcal). NMR spectroscopy will be performed to determine plasmatic Low Molecular Weight Metabolites (LMWM) and to characterize lipoprotein profiles (number of particles, lipid content and size of the main three lipoprotein classes (VLDL, LDL and HDL). Homeostatic (satiety, fullness) and hedonic sensations (digestive well-being, mood) will be measured by 10 cm analogical scales.
- Conditions
- Healthy
- Being tested
- Normal meal
- Keywords
- meal ingestion, postprandial sensations, circulating metabolites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal mealDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Meal ingestion | Experimental | Not described Receives: Dietary Supplement: Normal meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic response in serum
Measured: 30 min
Secondary outcomes (5)
Change in digestive well-being measured after the test meal
Change in average well-being measured by 10 score scales at the end of the test meal.
Measured: 1 day
Change in satiety measured after the test meal
Change in average satiety measured by 10 score scales at the end of the test meal
Measured: 1 day
Change in fullness sensation measured after the test meal
Change in average fullness measured by 10 score scales at the end of the test meal
Measured: 1 day
Change in abdominal discomfort/pain sensation measured after the test meal
Change in average abdominal discomfort/pain measured by 10 score scales at the end of the test meal
Measured: 1 day
Change in mood measured after the test meal
Change in average mood measured by 10 score scales at the end of the test meal.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start15 Nov 2014
- Primary completion30 Jun 2017
- Study completion15 Oct 2017
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 Hospital Universitari Vall d'Hebron Research InstituteThe 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
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383250
- Sponsor's protocol ID
- PR(AG)338/2016D
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors to Determine the Responses to Meal Ingestion: Circulating Metabolites
- ClinicalTrials.gov ID
- NCT03383250
- Acronym / sponsor ID
- PR(AG)338/2016D
- Conditions
- Healthy
- Keywords
- meal ingestion, postprandial sensations, circulating metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 15 Nov 2014 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 26 Dec 2017 (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.
The investigators have recently shown that postprandial sensations correlate with changes in circulating metabolites after a meal ingestion; however this phenomenon was demonstrated with a meal load up to the level of tolerance which involved an unpleasant fullness sensation. The aim of the present study is to determine changes in circulating metabolites of a satiating pleasurable meal. Healthy men (n = 32) will be evaluated after a 5 h fast. Perception measurements and blood samples will be taken before and 20 minutes after ingestion of a palatable probe meal (juice and warm ham and cheese sandwich, total 300 ml, 440 kcal). NMR spectroscopy will be performed to determine plasmatic Low Molecular Weight Metabolites (LMWM) and to characterize lipoprotein profiles (number of particles, lipid content and size of the main three lipoprotein classes (VLDL, LDL and HDL). Homeostatic (satiety, fullness) and hedonic sensations (digestive well-being, mood) will be measured by 10 cm analogical scales.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meal ingestion | Experimental | Dietary Supplement: Normal meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non obese
Key exclusion criteria (8 listed)
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
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 |
|---|---|---|
| Normal meal | Dietary supplement | Meal ingestion |
Primary outcome
Metabolomic response in serum
Time frame: 30 min
5 secondary outcomes
Change in digestive well-being measured after the test meal
Time frame: 1 day
Change in satiety measured after the test meal
Time frame: 1 day
Change in fullness sensation measured after the test meal
Time frame: 1 day
Change in abdominal discomfort/pain sensation measured after the test meal
Time frame: 1 day
Change in mood measured after the test meal
Time frame: 1 day
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 4 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Normal meal in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute.
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 1 inclusion and 8 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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Metabolomic response in serum (time frame: 30 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 4 Jan 2018.