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Effects of a Diet Based on Inulin-rich Vegetables on Gut Health and Nutritional Behaviour in Healthy Humans

Modification of the Gut Microbiota Following the Consumption of Inulin-rich Vegetables: Effect on Gut Tolerance, Transit, Behaviour and Digestion in Healthy Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03540550
Enrollment
26
Registered
2018-05-30
Start date
2016-03-04
Completion date
2016-04-12
Last updated
2018-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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. 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.

Interventions

OTHERDiet based on inulin-rich vegetables

During two weeks, healthy subjects were instructed to adhere to a controlled diet based on ITF-rich vegetables (±15 g ITF/day).

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI between 20 and 25 kg/m² * Caucasian ethnicity * Hydrogen producers (assessed by hydrogen breath test)

Exclusion criteria

* 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,...) * 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)

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota composition33 daysGut 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).

Secondary

MeasureTime frameDescription
Gut microbiota fermentation in vitro14 daysGut 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.
Gastrointestinal Symptoms33 daysGastrointestinal 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).
Gut microbiota fermentation in vivo33 daysGut 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.
Correlation of gastrointestinal symptoms with gut bacteria33 daysThe levels of gastrointestinal symptoms were correlated (Spearman correlations) with the relative abundance of bacterial taxa and OTUs (operational taxonomic units)
Short chain fatty acids production14 daysShort 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.
Appetite-related feelings33 daysAppetite-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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026