Functional Ingredients: Effect in Gastrointestinal System

NCT ID: NCT02467972

Last Updated: 2015-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Overweight Diabetes Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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UBF group

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

Group Type EXPERIMENTAL

Ready-to-eat frozen soups added unripe banana flour

Intervention Type DIETARY_SUPPLEMENT

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

Control

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

Group Type PLACEBO_COMPARATOR

Ready-to-eat frozen soups added maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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

Inulin group

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

Group Type EXPERIMENTAL

Ready-to-eat frozen soups added inulin

Intervention Type DIETARY_SUPPLEMENT

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

Nisin group

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

Group Type EXPERIMENTAL

Ready-to-eat frozen soups added nisin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Ready-to-eat frozen soups added unripe banana flour

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

Intervention Type DIETARY_SUPPLEMENT

Ready-to-eat frozen soups added maltodextrin

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

Intervention Type DIETARY_SUPPLEMENT

Ready-to-eat frozen soups added inulin

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

Intervention Type DIETARY_SUPPLEMENT

Ready-to-eat frozen soups added nisin

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Eliana Bistriche Giuntini

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabete W Menezes, Prof Assoc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmaceutical Sciences of University of Sao Paulo

Locations

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Faculty of Pharmaceutical Sciences USP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CONEP Brasil

Identifier Type: REGISTRY

Identifier Source: secondary_id

CONEP Brasil

Identifier Type: REGISTRY

Identifier Source: secondary_id

CEPFCF194 CEPFCF18

Identifier Type: -

Identifier Source: org_study_id

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