Effect of Food Insulin Index on Metabolic Parameters in Obese Adolescents

NCT03387293 | Completed DMC

• 1 other identifier: 116S069
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pediatric Obesity

Keywords

Pediatric Obesity; Insulin Resistance; Diet

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Four hours postprandial period

Secondary Outcomes (14)

• Hunger rating

  Four hours postprandial period

• Fullness rating

  Four hours postprandial period

• Desiring to eat

  Four hours postprandial period

• Prospective food consumption

  Four hours postprandial period

• Desiring for sweet

  Four hours postprandial period

Study Arms (2)

LGI-LII Breakfast

EXPERIMENTAL

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

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

Other: LGI-LII Breakfast; Other: LGI-HII Breakfast

Interventions

LGI-LII Breakfast 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; LGI-LII Breakfast

LGI-HII Breakfast 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; LGI-LII Breakfast

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: January 2, 2018
• Study Start: November 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 2, 2018

Record last verified: 2017-12