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临床试验/NCT01939600
NCT01939600已完成不适用

Digestibility of Selected Resistant Starches in Humans

Unity Health Toronto2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
Amount of carbohydrate in ileostomy effluent

研究概览

简要总结

Dietary fiber is a type of carbohydrate which is not digested in the human small intestine. Whole grains are a source of dietary fiber that are used to promote health; however, using whole grains in commercial products results in a different taste and/or texture than the usual products made from refined grains. Thus, other types of high-fiber ingredients have been developed which can be incorporated into food products with less effect on their taste and/or texture. An example of this is resistant starch, defined as starch which is not digested in the human small intestine. The digestibility of starch is usually determined in-vitro; however, there is evidence that such methods may overestimate the amount of resistant starch by as much as 100%. The measurement of the amount of carbohydrate in the ileal effluent, digestive waste, of subjects with an ileostomy is considered to be the best in-vivo method of starch digestibility. The subjects collect ileal effluent during the day during which time they consume a polysaccharide-free diet. There is evidence that resistant starch consumed at breakfast is completely recovered in ileal effluent 8-10hr after consumption. The purpose of this study will be to compare the carbohydrate content recovered in ileal effluent of 10 subjects with a conventional ileostomy.

详细描述

Dietary fiber consists mainly of carbohydrates which are not digested in the human small intestine. A high intake of dietary fiber is associated with many health benefits including, but not limited to, improved bowel function and reduced risk of weight gain, cardiovascular disease and diabetes. Therefore, there is great interest in the food industry to produce products enriched with dietary fiber to promote health. One way to achieve this is to use more whole grains (wheat, rice, oats, barley) as ingredients in products such as breakfast cereals, breads and food bars. However, the use of whole grains results in products which have a different taste and/or texture than the usual products made from refined grains. Thus, other types of high-fiber ingredients have been developed which can be incorporated into food products with less effect on their taste and/or texture. Examples of such ingredients are inulin (an oligosaccharide containing fructose) and resistant starch. Resistant starch, defined as starch which is not digested in the human small intestine, is present in small amounts (2-5% of total starch) in many normal foods.

Starch is the most abundant energy containing nutrient in the human diet; it consists of 2 types of polysaccharides: amylose, is a linear polymer consisting of long chains of glucose molecules joined by 1-4 linkages; and amylopectin, a highly branched polymer consisting of long chains of glucose molecules joined by 1-4 linkages with numerous 1-6 linkage branch points. Most (70-80%) of the starch in normal starchy foods (eg. cereals and potatoes) is amylopectin. Amylopectin is highly digestible because its branched structure makes it readily able to gelatinize, the process whereby adjacent starch molecules swell and separate from each other under the influence of moist heat (ie. cooking). By contrast amylose is less digestible because its linear structure allows adjacent molecules to associate by hydrogen bonding which reduces their ability to gelatinize. Some types of commercially available resistant starch come from strains of corn which produce starch containing 70 to 100% amylose.

The digestibility of starch is usually determined in-vitro using methods involving digestion of the starch with α-amylase under pH and temperature conditions thought to mimick digestion in the human small intestine. However, there is evidence that such methods may overestimate the amount of resistant starch by as much as 100%. Methods used to estimate starch digestibility in-vivo include the breath hydrogen method and the measurement of the amount of carbohydrate in the ileal effluent of subjects with an ileostomy. The latter is considered to be the best in-vivo method which involves preparation of subjects with a polysaccharide-free diet the day before then consumption of the test carbohydrate with breakfast. Subjects collect ileal effluent during the day during which time they consume a polysaccharide-free diet. There is evidence that resistant starch consumed at breakfast is completely recovered in ileal effluent 8-10hr after consumption. The objective of this study is to determine the amount of carbohydrates in 3 commercially available starches (Hi-Maize® 260, Hylon® VII and Amioca corn starch) which escape digestion in the human small intestine.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • males or non-pregnant females with a conventional ileostomy
  • clinically stable with no clinical evidence of malabsorption

排除标准

  • short bowel syndrome
  • acute exacerbation of inflammatory bowel disease
  • prone to high output with change in diet
  • ileostomy created less than 6 months from the first study visit
  • subjects using medications which influence gastrointestinal motility or absorption
  • any condition which might, in the opinion of Dr. Wolever or Dr. Kim either: 1) make participation dangerous to the subject or to others, or 2) affect the results
  • subjects who cannot or will not comply with the experimental procedures
  • food allergies of any kind

研究组 & 干预措施

All subjects

Experimental

All subjects will undergo all 4 treatments, starch-free breakfast, Hi-Maize 260, Hylon VII and Amioca in randomized order

干预措施: Starch-free breakfast (Other)

All subjects

Experimental

All subjects will undergo all 4 treatments, starch-free breakfast, Hi-Maize 260, Hylon VII and Amioca in randomized order

干预措施: Hi-Maize 260 (Other)

All subjects

Experimental

All subjects will undergo all 4 treatments, starch-free breakfast, Hi-Maize 260, Hylon VII and Amioca in randomized order

干预措施: Hylon VII (Other)

All subjects

Experimental

All subjects will undergo all 4 treatments, starch-free breakfast, Hi-Maize 260, Hylon VII and Amioca in randomized order

干预措施: Amioca (Other)

结局指标

主要结局

Amount of carbohydrate in ileostomy effluent

时间窗: Up to 10 hours after starting to consume breakfast

Carbohydrate in ileal effluent will be measured using by proximate analysis and expressed in grams.

次要结局

  • Amount of fiber in ileostomy effluent(Up to 10 hours after starting to consume breakfast)
  • Amount of starch in ileostomy effluent(Up to 10 hours after starting to consume breakfast)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Wolever

Scientist at Keenan Research Centre in the Li Ka Shing Knowledge Institute

Unity Health Toronto

研究点 (2)

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