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Completed

NCT Number: NCT03295968

IL-6 in Exercise-Induced Anorexia

This study investigates the effect of high intensity exercise, with and without the inflammation inhibitor, ibuprofen, on plasma levels of IL-6 and other selective biomarkers of inflammation and appetite on food intake and subjective ratings of appetite in normal-weight boys.

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Key information

Conditions

Appetitive Behavior Behavior Behavior, Animal Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

13 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 13-18 yrs, healthy, male

Exclusion criteria

  • female, heamatophobia, following a diete, diagnosed with diabetes or other metabolic diseases, scoring ≥11 on an Eating Habit Questionnaire

Treatment and study plan

High Intensity Exercise/Ibuprofen

Other

HIEX, with and without the inflammation inhibitor, ibuprofen, on plasma levels of IL-6 and other selective biomarkers of inflammation and appetite on food intake and subjective ratings of appetite in normal-weight boys.

Primary outcomes

  1. Food Intake

    Time frame: 100-120 min

    Participants were provided with ad libitum lunch meal, consisting of rice (Uncle Ben's, Bolton, ON, Canada), beef meatballs (President's Choice, Brampton, ON, Canada) and tomato sauce (Ragu, Mount Prospect, IL, USA) at 100 - 120 min. The meatballs were cut into small and uniform pieces and were mixed homogeneously with the other ingredients in a bowl. One bowl was a 479.5 g portion which represented 827.5 kcal, 30.8 g fat, 104.8 g carbohydrate and 30.2 g protein based on the weight consumed and the compositional information provided by the manufacturers. Two portions we served in 10 min intervals and FI from the pizza meal was calculated based on the weight consumed during the lunch. Participants were instructed to eat until comfortably and stay seated during the duration of the meal.

  2. Visual Analog Scale Appetite Scores

    Time frame: 0-120min

    Visual Analog Scales were employed to assess subjective appetite based on the following questionnaires: Determination to Eat, Hunger, Fullness and Prospective Food Consumption.

  3. Appetite Biomarkers

    Time frame: 0-120min

    Active Ghrelin, Blood Glucose, Insulin, Peptide-YY and Glucagon-like peptide-1 were determined as appetite biomarkers.

  4. Inflammatory and Stress Biomarkers

    Time frame: 0-120min

    Interleukin-6, Tumor necrosis factor alpha and cortisol were determined as appetite biomarkers.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

The Role of IL-6 in Exercise-Induced Anorexia in Normal-weight Boys

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 28, 2017
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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