Functional Ingredients: Effect in Gastrointestinal System

Functional Ingredients: Effect in Satiety and Intestinal Health

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)

Study Overview

• Status: Completed
• Conditions: Diabetes; Overweight; Constipation
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508000
    • Faculty of Pharmaceutical Sciences USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Elizabete W Menezes, Prof Assoc, Faculty of Pharmaceutical Sciences of University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 5, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Estimate): June 17, 2015
• Last Update Submitted That Met QC Criteria: June 15, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Hunger and satiety; Hormones gastrointestinal; Bowel movements
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Body Weight; Overweight; Constipation
• Other Study ID Numbers: CEPFCF194 CEPFCF18; CONEP Brasil (Registry Identifier: CAAE 0069.0.018.198-11)