HealthyNCT03540550
Effects of a Diet Based on Inulin-rich Vegetables on Gut Health and Nutritional Behaviour in Healthy Humans
A study testing Diet based on inulin-rich vegetables in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
Inulin-type fructans (ITF) are fermentable dietary fibres that can confer beneficial health effects through changes in the gut microbiota. However, their effect on gut sensitivity and nutritional behaviour is a matter of debate. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Diet based on inulin-rich vegetables
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2016to 12 Apr 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 20 and 25 kg/m²
- Caucasian ethnicity
- Hydrogen producers (assessed by hydrogen breath test)
Who cannot join
- Smokers
- Laxative consumption (<4 weeks)
- Severe intestinal problems
- Psychiatric problems or use of antipsychotic
- Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (<6 weeks)
- Specific dietary practise (vegetarian, vegan,...)
Show all 10Show fewer
- Specific dietary treatment (<6 weeks) (e.g. high protein diet)
- Excessive alcohol consumption (>3 glasses/day)
- Consumption of the following drugs: proton pump inhibitor, antidiabetic drugs, cholesterol lowering drugs
- Inconclusive acceptability test (regarding the protocol of the intervention and the vegetables used in the protocol)
About this study
Official title: Modification of the Gut Microbiota Following the Consumption of Inulin-rich Vegetables: Effect on Gut Tolerance, Transit, Behaviour and Digestion in Healthy Humans
Inulin-type fructans (ITF) are fermentable dietary fibres that can confer beneficial health effects through changes in the gut microbiota. However, their effect on gut sensitivity and nutritional behaviour is a matter of debate.
The investigators evaluated, in healthy individuals, the impact of shifting from their usual food habits towards a diet based on the daily consumption of ITF-rich vegetables on gut microbiota, gastro-intestinal symptoms and food-related behaviour.
- Conditions
- Healthy
- Being tested
- Diet based on inulin-rich vegetables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet based on inulin-rich vegetablesOther
During two weeks, healthy subjects were instructed to adhere to a controlled diet based on ITF-rich vegetables (±15 g ITF/day).
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | Not described Receives: Other: Diet based on inulin-rich vegetables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition
Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).
Measured: 33 days
Secondary outcomes (6)
Gut microbiota fermentation in vivo
Gut microbiota fermentation is assessed in vivo by an hydrogen breath test. After an oral load of purified inulin, the level of expired hydrogen (ppm) is measured.
Measured: 33 days
Gut microbiota fermentation in vitro
Gut microbiota fermentation is assessed in vitro by the measurement of total gas (ml/g of dry matter) produced from subject feces incubated with inulin-rich substrates.
Measured: 14 days
Gastrointestinal Symptoms
Gastrointestinal symptoms were assessed by Visual Analogue Scale (horizontal line of 100 mm). Each subject completed seven separate scales, one for each symptom (rumble, burp, bloating, discomfort, nausea, flatulence, cramp), ranging from "no sensation" (0 mm) to "very severe sensation" (100 mm).
Measured: 33 days
Appetite-related feelings
Appetite-related feelings were assessed by Visual Analogue Scale (horizontal line of 100 mm). Each subject completed seven separate scales, one for each appetite-related feeling (satiety, intention to eat, fullness, sweet envy, very sweet envy, fat envy, salt envy), ranging from "no sensation" (0 mm or 100 mm depending on the feeling) , to "very strong sensation" (0 mm or 100 mm depending on the feeling).
Measured: 33 days
Correlation of gastrointestinal symptoms with gut bacteria
The levels of gastrointestinal symptoms were correlated (Spearman correlations) with the relative abundance of bacterial taxa and OTUs (operational taxonomic units)
Measured: 33 days
Short chain fatty acids production
Short chain fatty acids (SCFAs) production was assessed in vitro by the measurement of total SCFAs (mg/g of dry matter) produced from subject feces incubated with inulin-rich substrates.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start4 Mar 2016
- Primary completion12 Apr 2016
- Study completion12 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Thissen, Pr., Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540550
- Sponsor's protocol ID
- B403201627275
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hiel S, Bindels LB, Pachikian BD, Kalala G, Broers V, Zamariola G, Chang BPI, Kambashi B, Rodriguez J, Cani PD, Neyrinck AM, Thissen JP, Luminet O, Bindelle J, Delzenne NM. Effects of a diet based on inulin-rich vegetables on gut health and nutritional behavior in healthy humans. Am J Clin Nutr. 2019 Jun 1;109(6):1683-1695. doi: 10.1093/ajcn/nqz001.
PubMed 31108510
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of the Gut Microbiota Following the Consumption of Inulin-rich Vegetables: Effect on Gut Tolerance, Transit, Behaviour and Digestion in Healthy Humans
- ClinicalTrials.gov ID
- NCT03540550
- Acronym / sponsor ID
- B403201627275
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 12 Apr 2016 (actual)
- Study completion
- 12 Apr 2016 (actual)
- First posted
- 30 May 2018 (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.
Inulin-type fructans (ITF) are fermentable dietary fibres that can confer beneficial health effects through changes in the gut microbiota. However, their effect on gut sensitivity and nutritional behaviour is a matter of debate.
The investigators evaluated, in healthy individuals, the impact of shifting from their usual food habits towards a diet based on the daily consumption of ITF-rich vegetables on gut microbiota, gastro-intestinal symptoms and food-related behaviour.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Other: Diet based on inulin-rich vegetables |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 20 and 25 kg/m²
- Caucasian ethnicity
- Hydrogen producers (assessed by hydrogen breath test)
Key exclusion criteria (10 listed)
- Smokers
- Laxative consumption (<4 weeks)
- Severe intestinal problems
- Psychiatric problems or use of antipsychotic
- Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (<6 weeks)
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 |
|---|---|---|
| Diet based on inulin-rich vegetablesDuring two weeks, healthy subjects were instructed to adhere to a controlled diet based on ITF-rich vegetables (±15 g ITF/day). | Other | Dietary intervention |
Primary outcome
Gut microbiota composition
Time frame: 33 days
Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).
6 secondary outcomes
Gut microbiota fermentation in vivo
Time frame: 33 days
Gut microbiota fermentation in vitro
Time frame: 14 days
Gastrointestinal Symptoms
Time frame: 33 days
Appetite-related feelings
Time frame: 33 days
Correlation of gastrointestinal symptoms with gut bacteria
Time frame: 33 days
Short chain fatty acids production
Time frame: 14 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 1 Jun 2018.
- Derived from this study: PubMed 31108510Hiel S, Bindels LB, Pachikian BD, Kalala G, Broers V, Zamariola G, Chang BPI, Kambashi B, Rodriguez J, Cani PD, Neyrinck AM, Thissen JP, Luminet O, Bindelle J, Delzenne NM. Effects of a diet based on inulin-rich vegetables on gut health and nutritional behavior in healthy humans. Am J Clin Nutr. 2019 Jun 1;109(6):1683-1695. doi: 10.1093/ajcn/nqz001.
- 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.
Jean-Paul Thissen, Pr. principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
A study testing Diet based on inulin-rich vegetables in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 10 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 1 Jun 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?
Gut microbiota composition (time frame: 33 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540550, which also lists 1 linked publication.
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 1 Jun 2018.