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Functional Ingredients: Effect in Gastrointestinal System

Primary Purpose

Overweight, Diabetes, Constipation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ready-to-eat frozen soups added unripe banana flour
Ready-to-eat frozen soups added maltodextrin
Ready-to-eat frozen soups added inulin
Ready-to-eat frozen soups added nisin
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Hunger and satiety, Hormones gastrointestinal, Bowel movements

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Faculty of Pharmaceutical Sciences USP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

UBF group

Control

Inulin group

Nisin group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in biochemical parameters
Changes measured by biochemical kit

Full Information

First Posted
June 3, 2015
Last Updated
June 15, 2015
Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02467972
Brief Title
Functional Ingredients: Effect in Gastrointestinal System
Official Title
Functional Ingredients: Effect in Satiety and Intestinal Health
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Diabetes, Constipation
Keywords
Hunger and satiety, Hormones gastrointestinal, Bowel movements

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UBF group
Arm Type
Experimental
Arm Description
Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week)
Arm Title
Inulin group
Arm Type
Experimental
Arm Description
Ready-to-eat frozen soups added inulin (18 portions; 3 times/week)
Arm Title
Nisin group
Arm Type
Experimental
Arm Description
Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready-to-eat frozen soups added unripe banana flour
Intervention Description
Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready-to-eat frozen soups added maltodextrin
Intervention Description
Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready-to-eat frozen soups added inulin
Intervention Description
Ready-to-eat frozen soups added inulin (18 portions; 3 times/week)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready-to-eat frozen soups added nisin
Intervention Description
Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)
Primary Outcome Measure Information:
Title
Change in hormonal parameters related to hunger and satiety.
Description
Changes in satiety measured by specific hormones kit
Time Frame
6 weeks
Title
Change in bowel function
Description
Changes measured by GSRS and daily questionnaires
Time Frame
6 weeks
Title
Change in colonic bacteria population
Description
Changes measured by microbiological analysis by r16SDNA sequencing
Time Frame
6 weeks
Title
Change in satiety
Description
Changes in satiety measured by Visual Analogue Scale questionnaire.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in biochemical parameters
Description
Changes measured by biochemical kit
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabete W Menezes, Prof Assoc
Organizational Affiliation
Faculty of Pharmaceutical Sciences of University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Pharmaceutical Sciences USP
City
Sao Paulo
ZIP/Postal Code
05508000
Country
Brazil

12. IPD Sharing Statement

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Functional Ingredients: Effect in Gastrointestinal System

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