Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Other: GI and fiber meals Other: meals |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
| Official Title: | Glycemic and Satiety Response to Meals With Different Fiber Content and Glycemic Index in Type 2 Diabetic Patients |
- glycemic control [ Time Frame: fasting and post-prandial (differents times during 180 minutes) ] [ Designated as safety issue: Yes ]glucose and insulin
- 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
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Flávia M Silva | 93771824 | flavia.moraes.silva@hotmail.com |
| Brazil | |
| Hospital de Clínicas de Porto Alegre | Recruiting |
| Porto Alegre, Rio Grande do Sul, Brazil | |
| Contact: Flávia M Silva 93771824 flavia.moraes.silva@hotmail.com | |
| Sub-Investigator: Thais Steemburgo | |
| Sub-Investigator: Caroline Kramer | |
| Sub-Investigator: Giovana Menegotto | |
| 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 |
More Information
No publications provided
| Responsible Party: | Mirela Jobim de Azevedo, Endocrine Division of Hospital de Clínicas de Porto Alegre |
| ClinicalTrials.gov Identifier: | NCT01410292 History of Changes |
| Other Study ID Numbers: | GPPG 10-0472 |
| Study First Received: | August 3, 2011 |
| Last Updated: | August 4, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Hospital de Clinicas de Porto Alegre:
|
fiber glycemic index glycemic response diabetes ghrelin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013