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Completed

NCT Number: NCT03540550

Effects of a Diet Based on Inulin-rich Vegetables on Gut Health and Nutritional Behaviour 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.

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Key information

Conditions

Healthy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Diet based on inulin-rich vegetables

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Gut microbiota fermentation in vivo

    Time frame: 33 days

    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.

  2. Gut microbiota fermentation in vitro

    Time frame: 14 days

    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.

  3. Gastrointestinal Symptoms

    Time frame: 33 days

    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).

  4. Appetite-related feelings

    Time frame: 33 days

    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).

  5. Correlation of gastrointestinal symptoms with gut bacteria

    Time frame: 33 days

    The levels of gastrointestinal symptoms were correlated (Spearman correlations) with the relative abundance of bacterial taxa and OTUs (operational taxonomic units)

  6. Short chain fatty acids production

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 30, 2018
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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