Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes

August 4, 2011 updated by: Hospital de Clinicas de Porto Alegre

Glycemic and Satiety Response to Meals With Different Fiber Content and Glycemic Index in Type 2 Diabetic Patients

The aim of this study is to assess the post-prandial response of four breakfast with different content of dietary fiber and glycemic index on glycemic response and satiety in patients with type 2 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Design study:

Single-blind crossover randomized clinical trial

Hypothesis:

A meal with high GI and high fiber content determines a lower glycemic response compared to a meal with high GI and low fiber content (fiber beneficial effect on glycemic response independent of glycemic index.

Test meals:

Four test meals isocaloric and with the same proportion of macronutrients will be evaluated (5 kcal/kg, 17% of energy provided by protein, 58% of energy provided by carbohydrates, and 25% of energy provided by fat):

Test Meal A:high glycemic index (GI= 60.3%) and high fiber content(5.88g) Test Meal B:high glycemic index (GI= 62.8%) and LOW fiber content(2.05g) Test Meal C:low glycemic index (GI= 37.0%) and high fiber content(5.75g) Test Meal D:low glycemic index (GI= 38.4%) and high fiber content(1.91g)

Outcomes:

Glycemic response: serum glucose and insulin Satiety response: serum ghrelin and subjective assessment of satiety by a specific scale for measurement of appetite in single test meal studies.

Logistic:

Patients will undergo a clinical, nutritional and laboratory evaluation for confirm the inclusion criteria and will be request to give their written informed consent.

All participants will test each meal with a mean of seven days separating the individual test days.A 12h fast will precede all the study visits.Pre-and postprandial blood samples will be draw to determine the concentrations of serum insulin and plasma glucose, and ghrelin through an antecubital cannula before and 15, 30, 45, 60, 90, 120 and 180 min after the test meals. The VAS scale will be applied in these times.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
        • Sub-Investigator:
          • Thais Steemburgo
        • Sub-Investigator:
          • Caroline Kramer
        • Sub-Investigator:
          • Giovana Menegotto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetes,
  • HbA1c < 9%,
  • BMI < 35kg/m²,
  • Metformin and/or diet as treatment for diabetes

Exclusion Criteria:

  • Use of insulin as diabetes treatment
  • digestive disease with malabsorption
  • diabetes neuropathy with gastroparesis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: meal D
low fiber and low GI
Other: GI and fiber meals
meals with different fiber content and glycemic index
Other: meals
four different meal regarding GI and fiber content
Experimental: meal C
low Fiber and High GI
Other: GI and fiber meals
meals with different fiber content and glycemic index
Other: meals
four different meal regarding GI and fiber content
Experimental: meal B
high Fiber and low GI
Other: GI and fiber meals
meals with different fiber content and glycemic index
Other: meals
four different meal regarding GI and fiber content
Experimental: meal A
high fiber and high GI meal
Other: GI and fiber meals
meals with different fiber content and glycemic index
Other: meals
four different meal regarding GI and fiber content

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycemic control
Time Frame: fasting and post-prandial (differents times during 180 minutes)
glucose and insulin
fasting and post-prandial (differents times during 180 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measures of satiety and appetite
Time Frame: fasting and post-prandial (different times for 180 min)
ghrelin and subjective analogue scale of appetite
fasting and post-prandial (different times for 180 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

  • Study Chair: Flávia M Silva, Hospital de Clínicas de Porto Alegre
  • Study Chair: Thais Steemburgo, Hospital de Clínicas de Porto Alegre
  • Study Chair: Caroline Kramer, Hospital de Clínicas de Porto Alegre
  • Study Chair: Giovana Menegotto, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

August 5, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPPG 10-0472

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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