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CompletedNCT03387293Updated Jan 2, 2018

Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents

An interventional study of LGI-LII Breakfast and LGI-HII Breakfast in Pediatric Obesity, sponsored by TC Erciyes University. Completed. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-01-02.

Sponsored by TC Erciyes University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pediatric Obesity

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Keywords

  • Pediatric Obesity
  • Insulin Resistance
  • Diet
03

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    LGI-LII Breakfast

    Low glycemic index, low insulin index (LGI-LII) breakfast as a test meal

    Other: LGI-LII Breakfast · Other: LGI-HII Breakfast

  • Experimental
    LGI-HII Breakfast

    Low glycemic index, high insulin index (LGI-HII) breakfast as a test meal

    Other: LGI-LII Breakfast · Other: LGI-HII Breakfast

Interventions

  • OtherLGI-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.

  • OtherLGI-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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)

  2. 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.

    Time frame: Four hours postprandial period

  3. 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.

    Time frame: Four hours postprandial period

Secondary outcomes

  1. 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.

    Time frame: Four hours postprandial period

  2. 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.

    Time frame: Four hours postprandial period

  3. 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.

    Time frame: Four hours postprandial period

  4. 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.

    Time frame: Four hours postprandial period

  5. 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.

    Time frame: Four hours postprandial period

  6. 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.

    Time frame: Four hours postprandial period

  7. 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.

    Time frame: Four hours postprandial period

  8. 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.

    Time frame: Four hours postprandial period

  9. 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.

    Time frame: Four hours after consuming test meal (at 240 minutes)

  10. 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).

    Time frame: Immediately after consuming test meal (at 15 minutes)

  11. 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).

    Time frame: Immediately after consuming test meal (at 15 minutes)

  12. 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).

    Time frame: Immediately after consuming test meal (at 15 minutes)

  13. 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).

    Time frame: Immediately after consuming test meal (at 15 minutes)

  14. 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).

    Time frame: Immediately after consuming test meal (at 15 minutes)

06

Study locations

No study locations are listed for this record.

07

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 2, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03387293
Lead sponsor
TC Erciyes University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Zeynep Caferoglu, PhD (Assistant Professor Doctor, TC Erciyes University) — Principal investigator
First posted
Jan 2, 2018
Start date
Nov 1, 2016
Primary completion
Mar 1, 2017
Completion
May 1, 2017
Last update
Jan 2, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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