Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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LGI-LII Breakfast

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

Group Type EXPERIMENTAL

LGI-LII Breakfast

Intervention Type OTHER

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 Breakfast

Intervention Type OTHER

In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.

LGI-HII Breakfast

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

Group Type EXPERIMENTAL

LGI-LII Breakfast

Intervention Type OTHER

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 Breakfast

Intervention Type OTHER

In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No