OverweightNCT02467972
Functional Ingredients: Effect in Gastrointestinal System
A study testing Ready-to-eat frozen soups added unripe banana flour, Ready-to-eat frozen soups added maltodextrin and Ready-to-eat frozen soups added inulin in people with Overweight and Diabetes, run by University of Sao Paulo at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Diabetes, Constipation
- What is being tested?
- Ready-to-eat frozen soups added unripe banana flour, Ready-to-eat frozen soups added maltodextrin and Ready-to-eat frozen soups added inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good health condition
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Pharmaceutical Sciences USP
São Paulo, São Paulo, 05508000
About this study
Official title: 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)
Read the 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.
- Conditions
- Overweight, Diabetes, Constipation
- Being tested
- Ready-to-eat frozen soups added unripe banana flour, Ready-to-eat frozen soups added maltodextrin, Ready-to-eat frozen soups added inulin, Ready-to-eat frozen soups added nisin
- Keywords
- Hunger and satiety, Hormones gastrointestinal, Bowel movements
- Medical subject headings
- Overweight, Diabetes Mellitus, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready-to-eat frozen soups added unripe banana flourDietary supplement
Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week)
Ready-to-eat frozen soups added maltodextrinDietary supplement
Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week)
Ready-to-eat frozen soups added inulinDietary supplement
Ready-to-eat frozen soups added inulin (18 portions; 3 times/week)
Ready-to-eat frozen soups added nisinDietary supplement
Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)
| Study group | Role | What they receive |
|---|---|---|
| UBF group | Experimental | Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week) Receives: Dietary Supplement: Ready-to-eat frozen soups added unripe banana flour |
| Control | Placebo comparator | Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week) Receives: Dietary Supplement: Ready-to-eat frozen soups added maltodextrin |
| Inulin group | Experimental | Ready-to-eat frozen soups added inulin (18 portions; 3 times/week) Receives: Dietary Supplement: Ready-to-eat frozen soups added inulin |
| Nisin group | Experimental | Ready-to-eat frozen soups added nisin (18 portions; 3 times/week) Receives: Dietary Supplement: Ready-to-eat frozen soups added nisin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hormonal parameters related to hunger and satiety.
Changes in satiety measured by specific hormones kit
Measured: 6 weeks
Change in bowel function
Changes measured by GSRS and daily questionnaires
Measured: 6 weeks
Change in colonic bacteria population
Changes measured by microbiological analysis by r16SDNA sequencing
Measured: 6 weeks
Change in satiety
Changes in satiety measured by Visual Analogue Scale questionnaire.
Measured: 6 weeks
Secondary outcomes (1)
Change in biochemical parameters
Changes measured by biochemical kit
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Eliana Bistriche Giuntini, University of Sao Paulo
- Investigators
- Elizabete W Menezes, Prof Assoc, Principal investigator, Faculty of Pharmaceutical Sciences of University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467972
- Sponsor's protocol ID
- CEPFCF194 CEPFCF18
- Other IDs
- CONEP Brasil, CONEP Brasil
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2015
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Ingredients: Effect in Satiety and Intestinal Health
- ClinicalTrials.gov ID
- NCT02467972
- Acronym / sponsor ID
- CEPFCF194 CEPFCF18
- Conditions
- Overweight, Diabetes, Constipation
- Keywords
- Hunger and satiety, Hormones gastrointestinal, Bowel movements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UBF group | Experimental | Dietary Supplement: Ready-to-eat frozen soups added unripe banana flourReady-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week) |
| Control | Placebo comparator | Dietary Supplement: Ready-to-eat frozen soups added maltodextrinReady-to-eat frozen soups added maltodextrin (18 portions; 3 times/week) |
| Inulin group | Experimental | Dietary Supplement: Ready-to-eat frozen soups added inulinReady-to-eat frozen soups added inulin (18 portions; 3 times/week) |
| Nisin group | Experimental | Dietary Supplement: Ready-to-eat frozen soups added nisinReady-to-eat frozen soups added nisin (18 portions; 3 times/week) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- good health condition
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready-to-eat frozen soups added unripe banana flourReady-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week) | Dietary supplement | UBF group |
| Ready-to-eat frozen soups added maltodextrinReady-to-eat frozen soups added maltodextrin (18 portions; 3 times/week) | Dietary supplement | Control |
| Ready-to-eat frozen soups added inulinReady-to-eat frozen soups added inulin (18 portions; 3 times/week) | Dietary supplement | Inulin group |
| Ready-to-eat frozen soups added nisinReady-to-eat frozen soups added nisin (18 portions; 3 times/week) | Dietary supplement | Nisin group |
Primary outcome
Change in hormonal parameters related to hunger and satiety.
Time frame: 6 weeks
Changes in satiety measured by specific hormones kit
Change in bowel function
Time frame: 6 weeks
Changes measured by GSRS and daily questionnaires
Change in colonic bacteria population
Time frame: 6 weeks
Changes measured by microbiological analysis by r16SDNA sequencing
Change in satiety
Time frame: 6 weeks
Changes in satiety measured by Visual Analogue Scale questionnaire.
1 secondary outcome
Change in biochemical parameters
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabete W Menezes, Prof Assoc principal investigator
Faculty of Pharmaceutical Sciences of University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready-to-eat frozen soups added unripe banana flour, Ready-to-eat frozen soups added maltodextrin and Ready-to-eat frozen soups added inulin in people with Overweight and Diabetes, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hormonal parameters related to hunger and satiety. (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2015.