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OpenTrials
Completed

NCT Number: NCT02467972

Functional Ingredients: Effect in Gastrointestinal System

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)

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Key information

Conditions

Overweight Body Weight Constipation Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Pharmaceutical Sciences USP

São Paulo, 05508000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ready-to-eat frozen soups added unripe banana flour

Dietary Supplement

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

Ready-to-eat frozen soups added maltodextrin

Dietary Supplement

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

Ready-to-eat frozen soups added inulin

Dietary Supplement

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

Ready-to-eat frozen soups added nisin

Dietary Supplement

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

Primary outcomes

  1. Change in hormonal parameters related to hunger and satiety.

    Time frame: 6 weeks

    Changes in satiety measured by specific hormones kit

  2. Change in bowel function

    Time frame: 6 weeks

    Changes measured by GSRS and daily questionnaires

  3. Change in colonic bacteria population

    Time frame: 6 weeks

    Changes measured by microbiological analysis by r16SDNA sequencing

  4. Change in satiety

    Time frame: 6 weeks

    Changes in satiety measured by Visual Analogue Scale questionnaire.

Secondary outcomes

  1. Change in biochemical parameters

    Time frame: 6 weeks

    Changes measured by biochemical kit

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Functional Ingredients: Effect in Satiety and Intestinal Health

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 10, 2015
Registry last updated
Jun 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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