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临床试验/NCT03982836
NCT03982836已完成不适用

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

Federal University of Minas Gerais2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年7月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Gastric Emptying Time and intestinal transit time

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

All subjects involved with this study will be masked. The masking was revealed only after the analysis of the results obtained.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Fructooligosaccharide

Experimental

All the 25 volunteers received the sandwich containing 20 grams of fructooligosaccharide

干预措施: Soluble Dietary Fibers (Dietary Supplement)

Partially hydrolyzed guar gum

Experimental

All the 25 volunteers received the sandwich containing 20 grams of partially hydrolyzed guar gum

干预措施: Soluble Dietary Fibers (Dietary Supplement)

Maltodextrin

Placebo Comparator

All the 25 volunteers received the sandwich containing 20 grams of Maltodextrin

干预措施: Soluble Dietary Fibers (Dietary Supplement)

结局指标

主要结局

Gastric Emptying Time and intestinal transit time

时间窗: 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.

次要结局

  • Intestinal Hormones Concentrations(Up to 3 weeks after protocol termination)
  • Compare gastric emptying and intestinal transit times between dietary fiber types(Up to 3 weeks after protocol termination)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Isabel Toulson Davisson Correia

Principal Investigator

Federal University of Minas Gerais

研究点 (2)

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