Dietary ModificationNCT02204384
Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus
A study testing HFD Meal: High fiber from food, HFS Meal: High fiber from supplement and UF Meal: usual amount of fiber in people with Dietary Modification and Diabetes Mellitus Type 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
To compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The hypothesis is a meal with a high content of soluble fiber from food determines glycemic and insulinemic response similar to a meal with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Modification, Diabetes Mellitus Type 2, Insulin Tolerance
- What is being tested?
- HFD Meal: High fiber from food, HFS Meal: High fiber from supplement and UF Meal: usual amount of fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes
- Body Mass Index (BMI) <= 35 kg / m²
- Hemoglobin A1c (HbA1c) <= 9%
Who cannot join
- Serum creatinine >2.0 mg/dL
- Digestive diseases (e.g. malabsorption)
- Severe autonomic neuropathy (presence of symptomatic postural hypotension, gastroparesis, diabetic diarrhea)
- Recent cardiovascular event
- Cachexia
- Psychiatric disorder with impairment of understanding
- Participating in other research protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Plasma Glucose and Insulin Responses After Consumption of Breakfasts With Different Sources of Soluble Fiber in Type 2 Diabetes Patients: a Randomized Crossover Clinical Trial
To compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The hypothesis is a meal with a high content of soluble fiber from food determines glycemic and insulinemic response similar to a meal with a high content of soluble fiber from supplement sources.
Read the detailed description
Three breakfasts (high amount of fiber from diet food sources - HFD, high amount of soluble fiber from guar gum supplement - HFS and usual amount of fiber -UF), isocaloric and similar distribution of carbohydrates, proteins and lipids, the order of breakfasts randomly determined. Meals HFD and HFS have the same amount of fiber from different sources, origin in food and supplement respectively. Meal UF consist of the same foods meal HFS, but without the use of soluble fiber supplement and white bread instead of rye bread (low fiber content in relation to meals HFD and HFS). The supplement (Sachet 5g - Fiber Mais ®: 60% guar gum and 40% inulin) will be added to the plain water to meal HFD.
- Conditions
- Dietary Modification, Diabetes Mellitus Type 2, Insulin Tolerance, Diabetic Blood Glucose Monitoring
- Being tested
- HFD Meal: High fiber from food, HFS Meal: High fiber from supplement, UF Meal: usual amount of fiber
- Keywords
- Dietary fiber, Dietary Supplements, Type 2 diabetes, Postprandial Period, Plasma insulin, Plasma glucose, Area Under Curve, Soluble fiber
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFD Meal: High fiber from foodOther
Also called HFD
High amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g)
HFS Meal: High fiber from supplementDietary supplement
Also called HFS
High amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - sachet 5 g Fiber Mais, Nestlé Brasil, São Paulo, BR
UF Meal: usual amount of fiberOther
Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)
| Study group | Role | What they receive |
|---|---|---|
| HFD Meal: high fiber from food | Experimental | HFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g) Receives: Other: HFD Meal: High fiber from food |
| HFS Meal: High fiber from supplement | Experimental | HFS Meal: high amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - Fiber Mais, Nestlé Receives: Dietary Supplement: HFS Meal: High fiber from supplement |
| UF Meal: usual amount of fiber | Experimental | UF Meal: usual amount of fiber (total fiber 2.4g; soluble fiber 0.8g) Receives: Other: UF Meal: usual amount of fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses
Measured: Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Mirela Jobim de Azevedo, Hospital de Clinicas de Porto Alegre
- Investigators
- Mirela J Azevedo, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204384
- Sponsor's protocol ID
- 140161
- Status last verified
- Feb 2017
- First submitted
- 28 Jul 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
de Carvalho CM, de Paula TP, Viana LV, Machado VM, de Almeida JC, Azevedo MJ. Plasma glucose and insulin responses after consumption of breakfasts with different sources of soluble fiber in type 2 diabetes patients: a randomized crossover clinical trial. Am J Clin Nutr. 2017 Nov;106(5):1238-1245. doi: 10.3945/ajcn.117.157263. Epub 2017 Aug 30.
PubMed 28855225
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Glucose and Insulin Responses After Consumption of Breakfasts With Different Sources of Soluble Fiber in Type 2 Diabetes Patients: a Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT02204384
- Acronym / sponsor ID
- 140161
- Conditions
- Dietary Modification, Diabetes Mellitus Type 2, Insulin Tolerance, Diabetic Blood Glucose Monitoring
- Keywords
- Dietary fiber, Dietary Supplements, Type 2 diabetes, Postprandial Period, Plasma insulin, Plasma glucose, Area Under Curve, Soluble fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Jul 2014 (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.
To compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The hypothesis is a meal with a high content of soluble fiber from food determines glycemic and insulinemic response similar to a meal with a high content of soluble fiber from supplement sources.
Detailed description
Three breakfasts (high amount of fiber from diet food sources - HFD, high amount of soluble fiber from guar gum supplement - HFS and usual amount of fiber -UF), isocaloric and similar distribution of carbohydrates, proteins and lipids, the order of breakfasts randomly determined. Meals HFD and HFS have the same amount of fiber from different sources, origin in food and supplement respectively. Meal UF consist of the same foods meal HFS, but without the use of soluble fiber supplement and white bread instead of rye bread (low fiber content in relation to meals HFD and HFS). The supplement (Sachet 5g - Fiber Mais ®: 60% guar gum and 40% inulin) will be added to the plain water to meal HFD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFD Meal: high fiber from food | Experimental | Other: HFD Meal: High fiber from foodHFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g) |
| HFS Meal: High fiber from supplement | Experimental | Dietary Supplement: HFS Meal: High fiber from supplementHFS Meal: high amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - Fiber Mais, Nestlé |
| UF Meal: usual amount of fiber | Experimental | Other: UF Meal: usual amount of fiberUF Meal: usual amount of fiber (total fiber 2.4g; soluble fiber 0.8g) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes
- Body Mass Index (BMI) <= 35 kg / m²
- Hemoglobin A1c (HbA1c) <= 9%
Key exclusion criteria (7 listed)
- Serum creatinine >2.0 mg/dL
- Digestive diseases (e.g. malabsorption)
- Severe autonomic neuropathy (presence of symptomatic postural hypotension, gastroparesis, diabetic diarrhea)
- Recent cardiovascular event
- Cachexia
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 |
|---|---|---|
| HFD Meal: High fiber from foodAlso: HFDHigh amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g) | Other | HFD Meal: high fiber from food |
| HFS Meal: High fiber from supplementAlso: HFSHigh amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - sachet 5 g Fiber Mais, Nestlé Brasil, São Paulo, BR | Dietary supplement | HFS Meal: High fiber from supplement |
| UF Meal: usual amount of fiberUsual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g) | Other | UF Meal: usual amount of fiber |
Primary outcome
Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses
Time frame: Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal
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 14 Feb 2017.
- Derived from this study: PubMed 28855225de Carvalho CM, de Paula TP, Viana LV, Machado VM, de Almeida JC, Azevedo MJ. Plasma glucose and insulin responses after consumption of breakfasts with different sources of soluble fiber in type 2 diabetes patients: a randomized crossover clinical trial. Am J Clin Nutr. 2017 Nov;106(5):1238-1245. doi: 10.3945/ajcn.117.157263. Epub 2017 Aug 30.
- Individual participant dataSharing planned: Undecided
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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.
Mirela J Azevedo, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFD Meal: High fiber from food, HFS Meal: High fiber from supplement and UF Meal: usual amount of fiber in people with Dietary Modification and Diabetes Mellitus Type 2, run by Hospital de Clinicas de Porto Alegre 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 3 inclusion and 7 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 14 Feb 2017. 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. 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?
Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses (time frame: Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02204384, which also lists 1 linked publication.
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 14 Feb 2017.