Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes
NCT ID: NCT01410292
Last Updated: 2011-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2011-03-31
2012-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SINGLE
Study Groups
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meal D
low fiber and low GI
GI and fiber meals
meals with different fiber content and glycemic index
meals
four different meal regarding GI and fiber content
meal C
low Fiber and High GI
GI and fiber meals
meals with different fiber content and glycemic index
meals
four different meal regarding GI and fiber content
meal B
high Fiber and low GI
GI and fiber meals
meals with different fiber content and glycemic index
meals
four different meal regarding GI and fiber content
meal A
high fiber and high GI meal
GI and fiber meals
meals with different fiber content and glycemic index
meals
four different meal regarding GI and fiber content
Interventions
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GI and fiber meals
meals with different fiber content and glycemic index
meals
four different meal regarding GI and fiber content
Eligibility Criteria
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Inclusion Criteria
* HbA1c \< 9%,
* BMI \< 35kg/m²,
* Metformin and/or diet as treatment for diabetes
Exclusion Criteria
* digestive disease with malabsorption
* diabetes neuropathy with gastroparesis
18 Years
80 Years
ALL
No
Sponsors
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Federal University of Rio Grande do Sul
OTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Endocrine Division of Hospital de Clínicas de Porto Alegre
Principal Investigators
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Flávia M Silva
Role: STUDY_CHAIR
Hospital de Clínicas de Porto Alegre
Thais Steemburgo
Role: STUDY_CHAIR
Hospital de Clínicas de Porto Alegre
Caroline Kramer
Role: STUDY_CHAIR
Hospital de Clínicas de Porto Alegre
Giovana Menegotto
Role: STUDY_CHAIR
Hospital de Clínicas de Porto Alegre
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Silva FM, Kramer CK, Crispim D, Azevedo MJ. A high-glycemic index, low-fiber breakfast affects the postprandial plasma glucose, insulin, and ghrelin responses of patients with type 2 diabetes in a randomized clinical trial. J Nutr. 2015 Apr;145(4):736-41. doi: 10.3945/jn.114.195339. Epub 2015 Feb 11.
Other Identifiers
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GPPG 10-0472
Identifier Type: -
Identifier Source: org_study_id
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