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

This study is currently recruiting participants.
Verified August 2011 by Hospital de Clinicas de Porto Alegre
Sponsor:
Collaborators:
Federal University of Rio Grande do Sul
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01410292
First received: August 3, 2011
Last updated: August 4, 2011
Last verified: August 2011

August 3, 2011
August 4, 2011
March 2011
September 2011   (final data collection date for primary outcome measure)
glycemic control [ Time Frame: fasting and post-prandial (differents times during 180 minutes) ] [ Designated as safety issue: Yes ]
glucose and insulin
Same as current
Complete list of historical versions of study NCT01410292 on ClinicalTrials.gov Archive Site
measures of satiety and appetite [ Time Frame: fasting and post-prandial (different times for 180 min) ] [ Designated as safety issue: Yes ]
ghrelin and subjective analogue scale of appetite
Same as current
Not Provided
Not Provided
 
Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Type 2 Diabetes Mellitus
  • 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 D
    low fiber and low GI
    Interventions:
    • Other: GI and fiber meals
    • Other: meals
  • Experimental: meal C
    low Fiber and High GI
    Interventions:
    • Other: GI and fiber meals
    • Other: meals
  • Experimental: meal B
    high Fiber and low GI
    Interventions:
    • Other: GI and fiber meals
    • Other: meals
  • Experimental: meal A
    high fiber and high GI meal
    Interventions:
    • Other: GI and fiber meals
    • Other: meals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2012
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Flávia M Silva 93771824 flavia.moraes.silva@hotmail.com
Brazil
 
NCT01410292
GPPG 10-0472
Yes
Mirela Jobim de Azevedo, Endocrine Division of Hospital de Clínicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
  • Federal University of Rio Grande do Sul
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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
Hospital de Clinicas de Porto Alegre
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP