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

NCT ID: NCT03540550

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-04
• Study Completion Date: 2016-04-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dietary intervention

Group Type: EXPERIMENTAL

Diet based on inulin-rich vegetables

Intervention Type: OTHER

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

Interventions

Diet 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).

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Paul Thissen, Pr.

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

References

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.

Reference Type: DERIVED

PMID: 31108510 (View on PubMed)

Other Identifiers

B403201627275

Identifier Type: -

Identifier Source: org_study_id