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Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus

Primary Purpose

Dietary Modification, Diabetes Mellitus Type 2, Insulin Tolerance

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
HFD Meal: High fiber from food
HFS Meal: High fiber from supplement
UF Meal: usual amount of fiber
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dietary Modification focused on measuring Dietary fiber, Dietary Supplements, Type 2 diabetes, Postprandial Period, Plasma insulin, Plasma glucose, Area Under Curve, Soluble fiber

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with type 2 diabetes
  • Body Mass Index (BMI) <= 35 kg / m²
  • Hemoglobin A1c (HbA1c) <= 9%

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

HFD Meal: high fiber from food

HFS Meal: High fiber from supplement

UF Meal: usual amount of fiber

Arm Description

HFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g)

HFS 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 (total fiber 2.4g; soluble fiber 0.8g)

Outcomes

Primary Outcome Measures

Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses

Secondary Outcome Measures

Full Information

First Posted
July 28, 2014
Last Updated
February 13, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT02204384
Brief Title
Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFD Meal: high fiber from food
Arm Type
Experimental
Arm Description
HFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g)
Arm Title
HFS Meal: High fiber from supplement
Arm Type
Experimental
Arm Description
HFS Meal: high amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - Fiber Mais, Nestlé
Arm Title
UF Meal: usual amount of fiber
Arm Type
Experimental
Arm Description
UF Meal: usual amount of fiber (total fiber 2.4g; soluble fiber 0.8g)
Intervention Type
Other
Intervention Name(s)
HFD Meal: High fiber from food
Other Intervention Name(s)
HFD
Intervention Description
High amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g)
Intervention Type
Dietary Supplement
Intervention Name(s)
HFS Meal: High fiber from supplement
Other Intervention Name(s)
HFS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
UF Meal: usual amount of fiber
Intervention Description
Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with type 2 diabetes Body Mass Index (BMI) <= 35 kg / m² Hemoglobin A1c (HbA1c) <= 9% Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirela J Azevedo, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28855225
Citation
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.
Results Reference
derived

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Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus

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