Functional Ingredients: Effect in Gastrointestinal System

Not Applicable

Completed

• Conditions: Diabetes; Constipation; Overweight

• Registration Number: NCT02467972
• Lead Sponsor: University of Sao Paulo

Brief Summary

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)

Detailed Description

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Status Verified: 2015-06
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-10
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• good health condition

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in hormonal parameters related to hunger and satiety.	6 weeks	Changes in satiety measured by specific hormones kit
Change in colonic bacteria population	6 weeks	Changes measured by microbiological analysis by r16SDNA sequencing
Change in satiety	6 weeks	Changes in satiety measured by Visual Analogue Scale questionnaire.
Change in bowel function	6 weeks	Changes measured by GSRS and daily questionnaires

Secondary Outcome Measures

Name	Time	Method
Change in biochemical parameters	6 weeks	Changes measured by biochemical kit

Trial Locations

Locations (1)

Faculty of Pharmaceutical Sciences USP; 🇧🇷 Sao Paulo, Brazil