Skip to content

Functional Ingredients: Effect in Gastrointestinal System

Functional Ingredients: Effect in Satiety and Intestinal Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02467972
Enrollment
61
Registered
2015-06-10
Start date
2012-04-30
Completion date
2012-12-31
Last updated
2015-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Diabetes, Overweight

Keywords

Hunger and satiety, Hormones gastrointestinal, Bowel movements

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.

Interventions

DIETARY_SUPPLEMENTReady-to-eat frozen soups added unripe banana flour

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

DIETARY_SUPPLEMENTReady-to-eat frozen soups added maltodextrin

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

DIETARY_SUPPLEMENTReady-to-eat frozen soups added inulin

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

DIETARY_SUPPLEMENTReady-to-eat frozen soups added nisin

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

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Change in hormonal parameters related to hunger and satiety.6 weeksChanges in satiety measured by specific hormones kit
Change in bowel function6 weeksChanges measured by GSRS and daily questionnaires
Change in colonic bacteria population6 weeksChanges measured by microbiological analysis by r16SDNA sequencing
Change in satiety6 weeksChanges in satiety measured by Visual Analogue Scale questionnaire.

Secondary

MeasureTime frameDescription
Change in biochemical parameters6 weeksChanges measured by biochemical kit

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026