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Trial record 96 of 405 for:    PYY

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

Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE July 21, 2018
Actual Primary Completion Date April 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Intestinal Hormones Concentrations [ Time Frame: Up to 3 weeks after protocol termination ]
    Dosage of serum concentrations
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Different Dietary Fibers in Gastric Emptying Time and Intestinal Transit of Healthy Volunteers
Official Title  ICMJE Impact of Different Dietary Fibers in Gastric Emptying Time and Intestinal Transit of Healthy Volunteers
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Gastric Emptying
  • Intestinal Transit Time
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Fructooligosaccharide
    All the 25 volunteers received the sandwich containing 20 grams of fructooligosaccharide
    Intervention: Dietary Supplement: Soluble Dietary Fibers
  • Experimental: Partially hydrolyzed guar gum
    All the 25 volunteers received the sandwich containing 20 grams of partially hydrolyzed guar gum
    Intervention: Dietary Supplement: Soluble Dietary Fibers
  • Placebo Comparator: Maltodextrin
    All the 25 volunteers received the sandwich containing 20 grams of Maltodextrin
    Intervention: Dietary Supplement: Soluble Dietary Fibers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 27, 2019
Actual Primary Completion Date April 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982836
Other Study ID Numbers  ICMJE CAAE: 85797918.1.0000.5149
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
Study Sponsor  ICMJE Federal University of Minas Gerais
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simone V Generoso Federal University of Minas Gerais
PRS Account Federal University of Minas Gerais
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP