HealthyNCT05197218
Prebiotic Properties of Phenolic Compounds
A study testing Prebiotic in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Gas evacuated per anus originates by-and-large in the colon, where unabsorbed meal residues are fermented by colonic bacteria. Within subjects, gas output varies in relation to the diet. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prebiotic
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2021to 29 Apr 2022
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- gastrointestinal symptoms
- recent (3 months) antibiotic intake
- change in dietary habits 4 weeks before
Trial locations and contacts
1 site in 1 country.
About this study
Gas evacuated per anus originates by-and-large in the colon, where unabsorbed meal residues are fermented by colonic bacteria. Within subjects, gas output varies in relation to the diet. However, there is a great interindividual variability: gas evacuation in subjects maintained on a similar diet may differ substantially, and this depends on the composition and metabolic pathways of the colonic microbiota. Hence, the volume of gas production and anal evacuation is determined by two main factors: the diet, particularly the amount of fermentable residues, and the individual composition of colonic microbiota. A series of recent studies suggest that some non-absorbable, fermentable meal products (prebiotics) serve as substrate to colonic bacteria and change their composition, thereby producing beneficial effects to the host. These products are fermented by bacteria and at initial intake increase gas production and may induce gas-related symptoms. However, after 7-10 days administration some prebiotics induce an adaptation of intestinal microbiota towards more efficient metabolic pathways with less gas production and the initial symptoms disappear. Some data suggest that phenolic compounds have prebiòtic properties. Aim of the study: to explore the prebiotic effect of a combination of two polyphenol-rich berry extracts (cranberry and chokeberry). Design: single-centre, single arm, open label, proof-of-concept study in healthy subjects. Intervention: a combination of a polyphenol rich extract of chokeberry (Aronia melanocarpa) and a polyphenol rich extract of cranberry (Vaccinium macrocarpon Aiton) will be administered for 18 days. Outcomes: during 2 days immediately before, at the beginning and at the end of the administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of an event marker; b) perception of digestive sensations by daily scales; c) microbiota composition by fecal analysis; d) metabolites in urine.
- Conditions
- Healthy
- Being tested
- Prebiotic
- Keywords
- intestinal gas, healthy subjects, microbiota, prebiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Combination of a polyphenol rich extract of chokeberry (Aronia melanocarpa) and a polyphenol rich extract of cranberry (Vaccinium macrocarpon Aiton) will be administered for 18 days.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Prebiotic administration Receives: Dietary Supplement: Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of daily anal gas evacuations
Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment
Measured: 18 days
Secondary outcomes (4)
Microbiota composition by fecal analysis
Change from beginning of treatment to end of treatment
Measured: 18 days
Sensation of flatulence by scales
Sensation of flatulence measured on a 0-10 scale graded from 0 (no flatulence) to 10 (very intense sensation). Change from beginning of treatment to end of treatment
Measured: 18 days
Sensation of abdominal bloating by scales
Sensation of abdominal bloating measured on a 0-10 scale graded from 0 (no bloating) to 10 (very intense sensation). Change from beginning of treatment to end of treatment.
Measured: 18 days
Sensation of digestive well-being by scales
Sensation of digestive well-being measured on a -5 to +5 scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation). Change from beginning of treatment to end of treatment
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jul 2021
- Primary completion31 Mar 2022
- Study completion29 Apr 2022
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.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197218
- Sponsor's protocol ID
- PR(AG)33/2021
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 9 Jun 2022
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotic Properties of Phenolic Compounds
- ClinicalTrials.gov ID
- NCT05197218
- Acronym / sponsor ID
- PR(AG)33/2021
- Conditions
- Healthy
- Keywords
- intestinal gas, healthy subjects, microbiota, prebiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 19 Jan 2022 (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.
Gas evacuated per anus originates by-and-large in the colon, where unabsorbed meal residues are fermented by colonic bacteria. Within subjects, gas output varies in relation to the diet. However, there is a great interindividual variability: gas evacuation in subjects maintained on a similar diet may differ substantially, and this depends on the composition and metabolic pathways of the colonic microbiota. Hence, the volume of gas production and anal evacuation is determined by two main factors: the diet, particularly the amount of fermentable residues, and the individual composition of colonic microbiota. A series of recent studies suggest that some non-absorbable, fermentable meal products (prebiotics) serve as substrate to colonic bacteria and change their composition, thereby producing beneficial effects to the host. These products are fermented by bacteria and at initial intake increase gas production and may induce gas-related symptoms. However, after 7-10 days administration some prebiotics induce an adaptation of intestinal microbiota towards more efficient metabolic pathways with less gas production and the initial symptoms disappear. Some data suggest that phenolic compounds have prebiòtic properties. Aim of the study: to explore the prebiotic effect of a combination of two polyphenol-rich berry extracts (cranberry and chokeberry). Design: single-centre, single arm, open label, proof-of-concept study in healthy subjects. Intervention: a combination of a polyphenol rich extract of chokeberry (Aronia melanocarpa) and a polyphenol rich extract of cranberry (Vaccinium macrocarpon Aiton) will be administered for 18 days. Outcomes: during 2 days immediately before, at the beginning and at the end of the administration phase participants will be put on a standard diet and the following outcomes will be measured: a) number of gas evacuations during daytime for 2 days by means of an event marker; b) perception of digestive sensations by daily scales; c) microbiota composition by fecal analysis; d) metabolites in urine.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Dietary Supplement: PrebioticPrebiotic administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (3 listed)
- gastrointestinal symptoms
- recent (3 months) antibiotic intake
- change in dietary habits 4 weeks before
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 |
|---|---|---|
| PrebioticCombination of a polyphenol rich extract of chokeberry (Aronia melanocarpa) and a polyphenol rich extract of cranberry (Vaccinium macrocarpon Aiton) will be administered for 18 days. | Dietary supplement | Healthy subjects |
Primary outcome
Number of daily anal gas evacuations
Time frame: 18 days
Change in the number of anal gas evacuations measured by an event marker from beginning of treatment to end of treatment
4 secondary outcomes
Microbiota composition by fecal analysis
Time frame: 18 days
Sensation of flatulence by scales
Time frame: 18 days
Sensation of abdominal bloating by scales
Time frame: 18 days
Sensation of digestive well-being by scales
Time frame: 18 days
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 9 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 3 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 9 Jun 2022. 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 Spain. 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?
Number of daily anal gas evacuations (time frame: 18 days). 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 9 Jun 2022.