Functional Ingredients: Effect in Gastrointestinal System

Diabetes Clinical Trial

Official title:

Functional Ingredients: Effect in Satiety and Intestinal Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467972
• Other study ID #: CEPFCF194 CEPFCF18
• Secondary ID: CONEP BrasilCONE
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: June 15, 2015
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Constipation
• Diabetes
• Overweight

Intervention

Dietary Supplement:
• Ready-to-eat frozen soups added unripe banana flour
Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week)
• Ready-to-eat frozen soups added maltodextrin
Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week)
• Ready-to-eat frozen soups added inulin
Ready-to-eat frozen soups added inulin (18 portions; 3 times/week)
• Ready-to-eat frozen soups added nisin
Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)

Locations

Country	Name	City	State
Brazil	Faculty of Pharmaceutical Sciences USP	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hormonal parameters related to hunger and satiety.	Changes in satiety measured by specific hormones kit	6 weeks	No
Primary	Change in bowel function	Changes measured by GSRS and daily questionnaires	6 weeks	No
Primary	Change in colonic bacteria population	Changes measured by microbiological analysis by r16SDNA sequencing	6 weeks	No
Primary	Change in satiety	Changes in satiety measured by Visual Analogue Scale questionnaire.	6 weeks	No
Secondary	Change in biochemical parameters	Changes measured by biochemical kit	6 weeks	No