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

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ClinicalTrials.gov Identifier: NCT03982836
Recruitment Status : Active, not recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

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

Condition or disease Intervention/treatment Phase
Gastric Emptying Intestinal Transit Time Dietary Supplement: Soluble Dietary Fibers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: It is a cross-sectional study, where the volunteer should attend the study area on three different days with a minimum washout of 7 days, each day receiving a sandwich containing one of the modules studied in a randomized manner (Partially Hydrolyzed Guar Gum, Fructooligosaccharide or Maltodextrin) and will be instructed to ingest this sandwich in the maximum time of 10 minutes. The volunteers should on an 8-hour fast. Samples of blood will be collected in the fasting, 60 and 180 minutes after the injection of the sandwich for intestinal hormone dosage.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All subjects involved with this study will be masked. The masking was revealed only after the analysis of the results obtained.
Primary Purpose: Basic Science
Official Title: Impact of Different Dietary Fibers in Gastric Emptying Time and Intestinal Transit of Healthy Volunteers
Actual Study Start Date : July 21, 2018
Actual Primary Completion Date : April 13, 2019
Estimated Study Completion Date : July 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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




Primary Outcome Measures :
  1. Gastric Emptying Time and intestinal transit time [ Time Frame: After the 3rd day of the protocol ]
    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.


Secondary Outcome Measures :
  1. Intestinal Hormones Concentrations [ Time Frame: Up to 3 weeks after protocol termination ]
    Dosage of serum concentrations

  2. Compare gastric emptying and intestinal transit times between dietary fiber types [ Time Frame: Up to 3 weeks after protocol termination ]
    To compare how the fibers influenced the time of gastric emptying and intestinal transit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982836


Locations
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Brazil
Escola de Enfermagem - UFMG
Belo Horizonte, MG, Brazil, 30130-100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Principal Investigator: Simone V Generoso Federal University of Minas Gerais

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Responsible Party: Maria Isabel Toulson Davisson Correia, Principal Investigator, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03982836     History of Changes
Other Study ID Numbers: CAAE: 85797918.1.0000.5149
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais:
Gastric Emptying
Scintigraphy
Intestinal Transit Time
Prebiotic
Soluble Dietary Fiber
Technetium-99m