Functional Ingredients: Effect in Gastrointestinal System

Study Overview
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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.

Official Title
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Functional Ingredients: Effect in Satiety and Intestinal Health

Conditions
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Overweight, Diabetes, Constipation

Intervention / Treatment
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* Dietary Supplement: Ready-to-eat frozen soups added unripe banana flour
* Dietary Supplement: Ready-to-eat frozen soups added maltodextrin
* Dietary Supplement: Ready-to-eat frozen soups added inulin
* Dietary Supplement: Ready-to-eat frozen soups added nisin


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UBF group<br>Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week) | Dietary Supplement: Ready-to-eat frozen soups added unripe banana flour<br>* Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week)<br>|
| Placebo Comparator: Control<br>Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week) | Dietary Supplement: Ready-to-eat frozen soups added maltodextrin<br>* Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week)<br>|
| Experimental: Inulin group<br>Ready-to-eat frozen soups added inulin (18 portions; 3 times/week) | Dietary Supplement: Ready-to-eat frozen soups added inulin<br>* Ready-to-eat frozen soups added inulin (18 portions; 3 times/week)<br>|
| Experimental: Nisin group<br>Ready-to-eat frozen soups added nisin (18 portions; 3 times/week) | Dietary Supplement: Ready-to-eat frozen soups added nisin<br>* Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biochemical parameters | Changes measured by biochemical kit | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hunger and satiety, Hormones gastrointestinal, Bowel movements