Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents

December 28, 2017 updated by: Zeynep Caferoglu, PhD, TC Erciyes University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LGI-LII Breakfast
Low glycemic index, low insulin index (LGI-LII) breakfast as a test meal
Other: LGI-LII Breakfast
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.
Other: LGI-HII Breakfast
In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.
Experimental: LGI-HII Breakfast
Low glycemic index, high insulin index (LGI-HII) breakfast as a test meal
Other: LGI-LII Breakfast
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.
Other: LGI-HII Breakfast
In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postprandial glucose response
Time Frame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
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
Time Frame: Four hours postprandial period
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
Time Frame: Four hours postprandial period
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hunger rating
Time Frame: Four hours postprandial period
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
Time Frame: Four hours postprandial period
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
Time Frame: Four hours postprandial period
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
Time Frame: Four hours postprandial period
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
Time Frame: Four hours postprandial period
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
Time Frame: Four hours postprandial period
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
Time Frame: Four hours postprandial period
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
Time Frame: Four hours postprandial period
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
Time Frame: Four hours after consuming test meal (at 240 minutes)
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
Time Frame: Immediately after consuming test meal (at 15 minutes)
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
Time Frame: Immediately after consuming test meal (at 15 minutes)
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
Time Frame: Immediately after consuming test meal (at 15 minutes)
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
Time Frame: Immediately after consuming test meal (at 15 minutes)
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
Time Frame: Immediately after consuming test meal (at 15 minutes)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 116S069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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