Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents

Study Overview
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Brief Summary
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The aim of this study was to determine the effect of food insulin index (FII) on metabolic parameters and appetite in obese adolescents with insulin resistance. A randomized, single-blind and crossover trial included 15 obese adolescents aged 12-18 years with insulin resistance. All participants were submitted two different breakfasts: low glycemic index, low insulin index (LGI-LII) and low glycemic index, high insulin index (LGI-HII), with a 1-week washout period between meals. At time 0 (just before breakfast), 15, 30, 45, 60, 90, 120, 180 and 240 minutes after the meal, serum glucose, insulin and c-peptide levels were measured and appetite was evaluated by visual analog scale. At the end of four hours, participants were served ad libitum lunch meal. Then, the foods eaten at lunch were recorded and their energy and nutrient analysis was calculated.

Official Title
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Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Other: LGI-LII Breakfast
* Other: LGI-HII Breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 12-18 years Age- and sex-specific body mass index (BMI) ≥95th percentile of the World Health Organization (WHO) growth-reference data New diagnosis and not receiving any treatment Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) >3.16 Exclusion Criteria: Hypertension, cardiovascular disease, diabetes mellitus or any other significant metabolic, endocrine or gastrointestinal disease Use of tobacco or alcohol Taking any medications Having difficulties for physical activity

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LGI-LII Breakfast<br>Low glycemic index, low insulin index (LGI-LII) breakfast as a test meal | Other: LGI-LII Breakfast<br>* This test meal with low GI and low FII amounts were served as a breakfast after 12-hours fasting and participants were asked to consume the meal in full, within 15 min.<br>Other: LGI-HII Breakfast<br>* In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.<br>|
| Experimental: LGI-HII Breakfast<br>Low glycemic index, high insulin index (LGI-HII) breakfast as a test meal | Other: LGI-LII Breakfast<br>* This test meal with low GI and low FII amounts were served as a breakfast after 12-hours fasting and participants were asked to consume the meal in full, within 15 min.<br>Other: LGI-HII Breakfast<br>* In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose response | Postprandial glucose response was quantified as area under the curve (AUC) (mg/dL x minutes), which was calculated according to the trapezoidal rule by using serum glucose values at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes. | Four hours postprandial period (from fasting to 240 minutes after the test breakfast) | 
| Postprandial insulin response | Postprandial insulin response was quantified as AUC (μU/mL x minutes), which was calculated according to the trapezoidal rule by using serum insulin values at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes. | Four hours postprandial period | 
| Postprandial C-peptide response | Postprandial C-peptide response was quantified as AUC (ng/mL x minutes), which was calculated according to the trapezoidal rule by using serum C-peptide values at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes. | Four hours postprandial period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hunger rating | Visual analogue scale (VAS) ratings were measured by using a question How hungry do you feel? (not at all hungry - as hungry as I ever felt) at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes, and hunger rating was quantified as AUC (mm x minutes), which was calculated according to the trapezoidal rule by using those VAS scores. | Four hours postprandial period | 
| Fullness rating | Visual analogue scale (VAS) ratings were measured by using a question How full do you feel? (not at all full - totally full) at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes, and fullness rating was quantified as AUC (mm x minutes), which was calculated according to the trapezoidal rule by using those VAS scores. | Four hours postprandial period | 
| Desiring to eat | Visual analogue scale (VAS) ratings were measured by using a question How strong is your desire to eat? (very weak - very strong) at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes, and desiring to eat was quantified as AUC (mm x minutes), which was calculated according to the trapezoidal rule by using those VAS scores. | Four hours postprandial period | 
| Prospective food consumption | Visual analogue scale (VAS) ratings were measured by using a question How much do you think you can eat? (no food at all - a large amount of food) at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes, and prospective food consumption was quantified as AUC (mm x minutes), which was calculated according to the trapezoidal rule by using those VAS scores. | Four hours postprandial period | 
| Desiring for sweet | Visual analogue scale (VAS) ratings were measured by using a question Would you like to eat something sweet? (No, not at all - Yes, very much) at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes, and desiring for sweet was quantified as AUC (mm x minutes), which was calculated according to the trapezoidal rule by using those VAS scores. | Four hours postprandial period | 
| Desiring for salty | Visual analogue scale (VAS) ratings were measured by using a question Would you like to eat something salty? (No, not at all - Yes, very much) at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes, and desiring for salty was quantified as AUC (mm x minutes), which was calculated according to the trapezoidal rule by using those VAS scores. | Four hours postprandial period | 
| Desiring for savoury | Visual analogue scale (VAS) ratings were measured by using a question Would you like to eat something savoury? (No, not at all - Yes, very much) at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes, and desiring for savoury was quantified as AUC (mm x minutes), which was calculated according to the trapezoidal rule by using those VAS scores. | Four hours postprandial period | 
| Desiring for fatty | Visual analogue scale (VAS) ratings were measured by using a question Would you like to eat something fatty? (No, not at all - Yes, very much) at time points 0, 15, 30, 45, 60, 90, 120, 180 and 240 minutes, and desiring for fatty was quantified as AUC (mm x minutes), which was calculated according to the trapezoidal rule by using those VAS scores. | Four hours postprandial period | 
| Subsequent energy consumption | At 240 minutes after the test breakfast, participants were presented with an ad libitum lunch following appetite sensation measurement. Participants selected from a buffet-style meal. During the lunch, participants were left alone in a quiet room with controlled lightning and ambient room temperature, and asked to consume whatever they wanted and to eat until they felt comfortably full. Foods were weighted or measured to the nearest 0.1 g before consumption, and any remaining food was reweighed to determine intake at lunch. Energy intake was calculated using The National Food Composition Database (TurKomp) and manufacturer labelling. | Four hours after consuming test meal (at 240 minutes) | 
| Visual appeal of test meal | Visual analogue scale (VAS) ratings were measured by using a question How is the visual appeal of test meal? (Good - Bad) at time points 15 minutes (immediately after consuming test meal). | Immediately after consuming test meal (at 15 minutes) | 
| Smell of test meal | Visual analogue scale (VAS) ratings were measured by using a question How is the smell of test meal? (Good - Bad) at time points 15 minutes (immediately after consuming test meal). | Immediately after consuming test meal (at 15 minutes) | 
| Taste of test meal | Visual analogue scale (VAS) ratings were measured by using a question How is the taste of test meal? (Good - Bad) at time points 15 minutes (immediately after consuming test meal). | Immediately after consuming test meal (at 15 minutes) | 
| Aftertaste of test meal | Visual analogue scale (VAS) ratings were measured by using a question Is there any perceived taste in your mouth after test meal? (Much - None) at time points 15 minutes (immediately after consuming test meal). | Immediately after consuming test meal (at 15 minutes) | 
| Palatability of test meal | Visual analogue scale (VAS) ratings were measured by using a question How is the palatability of test meal? (Good - Bad) at time points 15 minutes (immediately after consuming test meal). | Immediately after consuming test meal (at 15 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Obesity, Insulin Resistance, Diet