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

NCT03540550 | Completed

• 1 other identifier: B403201627275
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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).

  33 days

Secondary Outcomes (6)

• Gut microbiota fermentation in vivo

  33 days

• Gut microbiota fermentation in vitro

  14 days

• Gastrointestinal Symptoms

  33 days

• Appetite-related feelings

  33 days

• Correlation of gastrointestinal symptoms with gut bacteria

  33 days

Study Arms (1)

Dietary intervention

EXPERIMENTAL

Other: Diet based on inulin-rich vegetables

Interventions

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).

Dietary intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Related Publications (1)

• 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.

  PMID: 31108510 DERIVED

Study Officials

• Jean-Paul Thissen, Pr.

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 30, 2018
• Study Start: March 4, 2016
• Primary Completion: April 12, 2016
• Study Completion: April 12, 2016
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share