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Clinical Trials/NCT02467972
NCT02467972CompletedNot Applicable

Functional Ingredients: Effect in Satiety and Intestinal Health

University of Sao Paulo2 sites in 1 country61 target enrollmentStarted: April 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
2
Primary Endpoint
Change in hormonal parameters related to hunger and satiety.

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

Control

Placebo Comparator

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

Intervention: 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)

Intervention: 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)

Intervention: Ready-to-eat frozen soups added inulin (Dietary Supplement)

Nisin group

Experimental

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

Intervention: Ready-to-eat frozen soups added nisin (Dietary Supplement)

Outcomes

Primary Outcomes

Change in hormonal parameters related to hunger and satiety.

Time Frame: 6 weeks

Changes in satiety measured by specific hormones kit

Change in colonic bacteria population

Time Frame: 6 weeks

Changes measured by microbiological analysis by r16SDNA sequencing

Change in satiety

Time Frame: 6 weeks

Changes in satiety measured by Visual Analogue Scale questionnaire.

Change in bowel function

Time Frame: 6 weeks

Changes measured by GSRS and daily questionnaires

Secondary Outcomes

  • Change in biochemical parameters(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eliana Bistriche Giuntini

PhD

University of Sao Paulo

Study Sites (2)

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