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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien
- Rekrytering
- Hospital de Clinicas de Porto Alegre
-
Kontakt:
- Flávia M Silva
- Telefonnummer: 93771824
- E-post: flavia.moraes.silva@hotmail.com
-
Underutredare:
- Thais Steemburgo
-
Underutredare:
- Caroline Kramer
-
Underutredare:
- Giovana Menegotto
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: meal D
low fiber and low GI
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
|
Experimentell: meal C
low Fiber and High GI
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
|
Experimentell: meal B
high Fiber and low GI
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
|
Experimentell: meal A
high fiber and high GI meal
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
glycemic control
Tidsram: fasting and post-prandial (differents times during 180 minutes)
|
glucose and insulin
|
fasting and post-prandial (differents times during 180 minutes)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
measures of satiety and appetite
Tidsram: 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)
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Flávia M Silva, Hospital de Clinicas de Porto Alegre
- Studiestol: Thais Steemburgo, Hospital de Clinicas de Porto Alegre
- Studiestol: Caroline Kramer, Hospital de Clinicas de Porto Alegre
- Studiestol: Giovana Menegotto, Hospital de Clinicas de Porto Alegre
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GPPG 10-0472
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