Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LGI-LII Breakfast
LGI-HII Breakfast
Sponsored by
About this trial
This is an interventional screening trial for Pediatric Obesity focused on measuring Pediatric Obesity, Insulin Resistance, Diet
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
LGI-LII Breakfast
LGI-HII Breakfast
Arm Description
Low glycemic index, low insulin index (LGI-LII) breakfast as a test meal
Low glycemic index, high insulin index (LGI-HII) breakfast as a test meal
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
Full Information
NCT ID
NCT03387293
First Posted
December 12, 2017
Last Updated
December 28, 2017
Sponsor
TC Erciyes University
Collaborators
The Scientific and Technological Research Council of Turkey
1. Study Identification
Unique Protocol Identification Number
NCT03387293
Brief Title
Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents
Official Title
Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
Collaborators
The Scientific and Technological Research Council of Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Pediatric Obesity, Insulin Resistance, Diet
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LGI-LII Breakfast
Arm Type
Experimental
Arm Description
Low glycemic index, low insulin index (LGI-LII) breakfast as a test meal
Arm Title
LGI-HII Breakfast
Arm Type
Experimental
Arm Description
Low glycemic index, high insulin index (LGI-HII) breakfast as a test meal
Intervention Type
Other
Intervention Name(s)
LGI-LII Breakfast
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
LGI-HII Breakfast
Intervention Description
In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.
Primary Outcome Measure Information:
Title
Postprandial glucose response
Description
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.
Time Frame
Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
Title
Postprandial insulin response
Description
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.
Time Frame
Four hours postprandial period
Title
Postprandial C-peptide response
Description
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.
Time Frame
Four hours postprandial period
Secondary Outcome Measure Information:
Title
Hunger rating
Description
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.
Time Frame
Four hours postprandial period
Title
Fullness rating
Description
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.
Time Frame
Four hours postprandial period
Title
Desiring to eat
Description
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.
Time Frame
Four hours postprandial period
Title
Prospective food consumption
Description
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.
Time Frame
Four hours postprandial period
Title
Desiring for sweet
Description
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.
Time Frame
Four hours postprandial period
Title
Desiring for salty
Description
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.
Time Frame
Four hours postprandial period
Title
Desiring for savoury
Description
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.
Time Frame
Four hours postprandial period
Title
Desiring for fatty
Description
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.
Time Frame
Four hours postprandial period
Title
Subsequent energy consumption
Description
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.
Time Frame
Four hours after consuming test meal (at 240 minutes)
Title
Visual appeal of test meal
Description
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).
Time Frame
Immediately after consuming test meal (at 15 minutes)
Title
Smell of test meal
Description
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).
Time Frame
Immediately after consuming test meal (at 15 minutes)
Title
Taste of test meal
Description
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).
Time Frame
Immediately after consuming test meal (at 15 minutes)
Title
Aftertaste of test meal
Description
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).
Time Frame
Immediately after consuming test meal (at 15 minutes)
Title
Palatability of test meal
Description
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).
Time Frame
Immediately after consuming test meal (at 15 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents
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