Impact of Different Dietary Fibers in Gastric Emptying Time and Intestinal Transit of Healthy Volunteers

NCT ID: NCT03982836

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-21
• Study Completion Date: 2019-09-30

Brief Summary

The digestive process begins in the mouth and follows in the stomach and intestine. In the stomach the food is mixed with the gastric juices forming the chyme. To mix the food with the gastric juice as well as to provide gastric emptying (GE), the movements of the stomach are of great importance. Intestinal transit time is understood of the combination of GE, small intestine transit and colon transit time. The composition of the diet (lipid and protein content) exerts a direct influence on intestinal transit time due to the stimulation of hormone secretion, cholecystokinin and gastrin, respectively, which act to decrease GE velocity. In this context, it is also observed an important influence of dietary fibers on the speed of GE. Despite all knowledge about dietary fibers, information on such compounds still has many controversies. Due to the difficulty of finding compounds that fit into only one specific category (viscous, fermentable or prebiotic) there is difficulty in establishing a concept that best defines what are dietary fibers. The CODEX Alimentarius Commission in 2009 defined dietary fibers as carbohydrate polymers composed of ten or more monomer units of this macronutrient, which are not hydrolyzed by enzymes in the human intestine. Dietary fibers can be classified into insoluble and soluble according to the ability to bind to water molecules and form gels. Soluble fibers, especially those classified as prebiotic, in the intestine are fermented by bacteria giving rise to short chain fatty acids (SCFA). The SCFA stimulates the production and secretion of PYY and GLP-1 are associated with inhibition of gastric motility. Due to the importance of knowing the intestinal transit time, several methods have been developed, but scintigraphy is the gold standard technique for this analysis. Given the above and controversies present in the literature on the dietary fibers, there was a shortage of studies with the objective of evaluating the impact of different dietary fibers in intestinal transit time. This study shows relevant to help elucidate the behavior of different dietary fibers in intestinal transit time, offering data for correct and safe use of dietary fibers in various clinical situations. The hypothesis of this study is that the partially hydrolyzed guar gum delays the time of gastric emptying and intestinal transit, being this effect not observed for fructooligosaccharide

Conditions

Gastric Emptying; Intestinal Transit Time

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Fructooligosaccharide

All the 25 volunteers received the sandwich containing 20 grams of fructooligosaccharide

Group Type: EXPERIMENTAL

Soluble Dietary Fibers

Intervention Type: DIETARY_SUPPLEMENT

All 25 volunteers received, were separated for 7 days of washout, one containing maltodextrin (control), Frutooligossacharide or guar gum partially hydrolyzed in a randomized manner. As the partially hydrolyzed guar gum and fructooligosaccharide, soluble dietary fibers that present different behaviors in the body.

Partially hydrolyzed guar gum

All the 25 volunteers received the sandwich containing 20 grams of partially hydrolyzed guar gum

Group Type: EXPERIMENTAL

Soluble Dietary Fibers

Intervention Type: DIETARY_SUPPLEMENT

All 25 volunteers received, were separated for 7 days of washout, one containing maltodextrin (control), Frutooligossacharide or guar gum partially hydrolyzed in a randomized manner. As the partially hydrolyzed guar gum and fructooligosaccharide, soluble dietary fibers that present different behaviors in the body.

Maltodextrin

All the 25 volunteers received the sandwich containing 20 grams of Maltodextrin

Group Type: PLACEBO_COMPARATOR

Soluble Dietary Fibers

Intervention Type: DIETARY_SUPPLEMENT

All 25 volunteers received, were separated for 7 days of washout, one containing maltodextrin (control), Frutooligossacharide or guar gum partially hydrolyzed in a randomized manner. As the partially hydrolyzed guar gum and fructooligosaccharide, soluble dietary fibers that present different behaviors in the body.

Interventions

Soluble Dietary Fibers

All 25 volunteers received, were separated for 7 days of washout, one containing maltodextrin (control), Frutooligossacharide or guar gum partially hydrolyzed in a randomized manner. As the partially hydrolyzed guar gum and fructooligosaccharide, soluble dietary fibers that present different behaviors in the body.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Prebiotic; Partially hydrolyzed guar gum

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers;
• Both sexes;
• Age Range:From 18 to 40 years old
• Volunteers who do not have gluten or egg restriction
• No history or diagnosis of gastrointestinal diseases;
• Had not undergone recent operations that compromised intestinal transit time and / or gastric emptying.

Exclusion Criteria

• Volunteers who used prebiotic, probiotic and / or symbiotic volunteers at least 10 days prior to study day;
• Volunteers diagnosed with hypothyroidism and / or diabetes or who reported hypoglycemia and not tolerance to fasting;
• Women were asked about pregnancy, suspected pregnancy, use of contraceptive methods and menstrual cycle. If there was any possibility of pregnancy, based on these questions, the volunteer was excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Maria Isabel Toulson Davisson Correia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone V Generoso

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Escola de Enfermagem - UFMG

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

CAAE: 85797918.1.0000.5149

Identifier Type: -

Identifier Source: org_study_id