Pediatric ObesityNCT03387293
Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents
A study testing LGI-LII Breakfast and LGI-HII Breakfast in people with Pediatric Obesity, run by TC Erciyes University.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- LGI-LII Breakfast and LGI-HII Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Pediatric Obesity
- Being tested
- LGI-LII Breakfast, LGI-HII Breakfast
- Keywords
- Pediatric Obesity, Insulin Resistance, Diet
- Medical subject headings
- Pediatric Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGI-LII BreakfastOther
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.
LGI-HII BreakfastOther
In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.
| Study group | Role | What they receive |
|---|---|---|
| LGI-LII Breakfast | Experimental | Low glycemic index, low insulin index (LGI-LII) breakfast as a test meal Receives: Other: LGI-LII Breakfast; Other: LGI-HII Breakfast |
| LGI-HII Breakfast | Experimental | Low glycemic index, high insulin index (LGI-HII) breakfast as a test meal Receives: Other: LGI-LII Breakfast; Other: LGI-HII Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Four hours postprandial period
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Immediately after consuming test meal (at 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Nov 2016
- Primary completion1 Mar 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Zeynep Caferoglu, PhD, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387293
- Sponsor's protocol ID
- 116S069
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents
- ClinicalTrials.gov ID
- NCT03387293
- Acronym / sponsor ID
- 116S069
- Conditions
- Pediatric Obesity
- Keywords
- Pediatric Obesity, Insulin Resistance, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGI-LII Breakfast | Experimental | Other: LGI-LII Breakfast, Other: LGI-HII BreakfastLow glycemic index, low insulin index (LGI-LII) breakfast as a test meal |
| LGI-HII Breakfast | Experimental | Other: LGI-LII Breakfast, Other: LGI-HII BreakfastLow glycemic index, high insulin index (LGI-HII) breakfast as a test meal |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LGI-LII BreakfastThis 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, LGI-LII Breakfast |
| LGI-HII BreakfastIn crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast. | Other | LGI-HII Breakfast, LGI-LII Breakfast |
Primary outcome
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.
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.
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.
14 secondary outcomes
Hunger rating
Time frame: Four hours postprandial period
Fullness rating
Time frame: Four hours postprandial period
Desiring to eat
Time frame: Four hours postprandial period
Prospective food consumption
Time frame: Four hours postprandial period
Desiring for sweet
Time frame: Four hours postprandial period
Desiring for salty
Time frame: Four hours postprandial period
Desiring for savoury
Time frame: Four hours postprandial period
Desiring for fatty
Time frame: Four hours postprandial period
Subsequent energy consumption
Time frame: Four hours after consuming test meal (at 240 minutes)
Visual appeal of test meal
Time frame: Immediately after consuming test meal (at 15 minutes)
Smell of test meal
Time frame: Immediately after consuming test meal (at 15 minutes)
Taste of test meal
Time frame: Immediately after consuming test meal (at 15 minutes)
Aftertaste of test meal
Time frame: Immediately after consuming test meal (at 15 minutes)
Palatability of test meal
Time frame: Immediately after consuming test meal (at 15 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LGI-LII Breakfast and LGI-HII Breakfast in people with Pediatric Obesity, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose response (time frame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.