Clinical trial NCT03387293: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Pediatric Obesity
Insulin Resistance
Diet
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2018-01-02
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Postprandial glucose response
timeFrame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
measure: Postprandial insulin response
timeFrame: Four hours postprandial period
measure: Postprandial C-peptide response
timeFrame: Four hours postprandial period
Secondary outcomes:
measure: Hunger rating
timeFrame: Four hours postprandial period
measure: Fullness rating
timeFrame: Four hours postprandial period
measure: Desiring to eat
timeFrame: Four hours postprandial period
measure: Prospective food consumption
timeFrame: Four hours postprandial period
measure: Desiring for sweet
timeFrame: Four hours postprandial period
measure: Desiring for salty
timeFrame: Four hours postprandial period
measure: Desiring for savoury
timeFrame: Four hours postprandial period
measure: Desiring for fatty
timeFrame: Four hours postprandial period
measure: Subsequent energy consumption
timeFrame: Four hours after consuming test meal (at 240 minutes)
measure: Visual appeal of test meal
timeFrame: Immediately after consuming test meal (at 15 minutes)
measure: Smell of test meal
timeFrame: Immediately after consuming test meal (at 15 minutes)
measure: Taste of test meal
timeFrame: Immediately after consuming test meal (at 15 minutes)
measure: Aftertaste of test meal
timeFrame: Immediately after consuming test meal (at 15 minutes)
measure: Palatability of test meal
timeFrame: Immediately after consuming test meal (at 15 minutes)
Other outcomes:
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