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临床试验/NCT02467972
NCT02467972已完成不适用

Functional Ingredients: Effect in Satiety and Intestinal Health

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2012年4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
61
试验地点
2
主要终点
Change in hormonal parameters related to hunger and satiety.

研究概览

简要总结

The addition of fructans or unripe banana flour to frozen meals can change the hormonal parameters related to hunger and satiety, improve the bowel movements and increase in colonic bacteria population measured by microbiological determinations (qPCR). The inulin no can change bowel movements and increase in colonic bacteria population measured by microbiological determinations (qPCR)

详细描述

Non-transmissible chronic diseases have been constantly related to the consumption of diets with inadequate nutrient input; at the same time, the ingestion of unavailable carbohydrates have presented an inverse relationship with the risk for these diseases. Among these carbohydrates is inulin, a fructan considered as a prebiotic and the unripe banana flour, rich in resistant starch, which may contribute to the intestinal health.

This study evaluated the effect of regular intake of frozen soups added functional ingredients (fructans and unripe banana flour) by heath volunteers, about gastrointestinal hormones, satiety and bowel movements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • good health condition

排除标准

  • history of renal or gastrointestinal disease
  • hyperthyroidism
  • diabetes, nor parents with diabetes
  • for women: not pregnant, breastfeeding or using hormonal therapy
  • using any drug that might affect the digestion of food and absorption (antibiotics, laxatives)

研究组 & 干预措施

Control

Placebo Comparator

Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week)

干预措施: Ready-to-eat frozen soups added maltodextrin (Dietary Supplement)

UBF group

Experimental

Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week)

干预措施: Ready-to-eat frozen soups added unripe banana flour (Dietary Supplement)

Inulin group

Experimental

Ready-to-eat frozen soups added inulin (18 portions; 3 times/week)

干预措施: Ready-to-eat frozen soups added inulin (Dietary Supplement)

Nisin group

Experimental

Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)

干预措施: Ready-to-eat frozen soups added nisin (Dietary Supplement)

结局指标

主要结局

Change in hormonal parameters related to hunger and satiety.

时间窗: 6 weeks

Changes in satiety measured by specific hormones kit

Change in colonic bacteria population

时间窗: 6 weeks

Changes measured by microbiological analysis by r16SDNA sequencing

Change in satiety

时间窗: 6 weeks

Changes in satiety measured by Visual Analogue Scale questionnaire.

Change in bowel function

时间窗: 6 weeks

Changes measured by GSRS and daily questionnaires

次要结局

  • Change in biochemical parameters(6 weeks)

研究者

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

Eliana Bistriche Giuntini

PhD

University of Sao Paulo

研究点 (2)

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