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

Gastric Emptying Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03982836
• Other study ID #: CAAE: 85797918.1.0000.5149
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2018
• Est. completion date: July 27, 2019

Study information

• Verified date: June 2019
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: July 27, 2019
• Est. primary completion date: April 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Emptying
• Intestinal Transit Time

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Brazil	Escola de Enfermagem - UFMG	Belo Horizonte	MG

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric Emptying Time and intestinal transit time	The impact of the fibers under the gastric emptying and intestinal transit time is evaluated after the volunteer performs the ingestion of the 3 modules on different days.	After the 3rd day of the protocol
Secondary	Intestinal Hormones Concentrations	Dosage of serum concentrations	Up to 3 weeks after protocol termination
Secondary	Compare gastric emptying and intestinal transit times between dietary fiber types	To compare how the fibers influenced the time of gastric emptying and intestinal transit	Up to 3 weeks after protocol termination