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

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

Study Overview

• Status: Unknown
• Conditions: Gastric Emptying; Intestinal Transit Time
• Intervention / Treatment: Dietary supplement: Soluble Dietary Fibers

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • MG
    • Belo Horizonte, MG, Brazil, 30130-100
      • Escola de Enfermagem - UFMG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fructooligosaccharide; All the 25 volunteers received the sandwich containing 20 grams of fructooligosaccharide	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.; Other Names: Prebiotic; Partially hydrolyzed guar gum
EXPERIMENTAL: Partially hydrolyzed guar gum; All the 25 volunteers received the sandwich containing 20 grams of partially hydrolyzed guar gum	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.; Other Names: Prebiotic; Partially hydrolyzed guar gum
PLACEBO_COMPARATOR: Maltodextrin; All the 25 volunteers received the sandwich containing 20 grams of Maltodextrin	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.; Other Names: Prebiotic; Partially hydrolyzed guar gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal Hormones Concentrations	Dosage of serum concentrations	Up to 3 weeks after protocol termination
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

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Simone V Generoso, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2018
• Primary Completion (ACTUAL): April 13, 2019
• Study Completion (ANTICIPATED): July 27, 2019

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (ACTUAL): June 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Prebiotic; Gastric Emptying; Scintigraphy; Soluble Dietary Fiber; Intestinal Transit Time; Technetium-99m
• Other Study ID Numbers: CAAE: 85797918.1.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No