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

Study Overview
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Brief Summary
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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

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

Conditions
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Gastric Emptying, Intestinal Transit Time

Intervention / Treatment
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* Dietary Supplement: Soluble Dietary Fibers


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fructooligosaccharide<br>All the 25 volunteers received the sandwich containing 20 grams of fructooligosaccharide | Dietary Supplement: Soluble Dietary Fibers<br>* 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.<br>* Other names: Partially hydrolyzed guar gum;|
| Experimental: Partially hydrolyzed guar gum<br>All the 25 volunteers received the sandwich containing 20 grams of partially hydrolyzed guar gum | Dietary Supplement: Soluble Dietary Fibers<br>* 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.<br>* Other names: Partially hydrolyzed guar gum;|
| Placebo Comparator: Maltodextrin<br>All the 25 volunteers received the sandwich containing 20 grams of Maltodextrin | Dietary Supplement: Soluble Dietary Fibers<br>* 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.<br>* Other names: Partially hydrolyzed guar gum;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Emptying, Scintigraphy, Intestinal Transit Time, Prebiotic, Soluble Dietary Fiber, Technetium-99m