Skip to main content
OpenTrials
Completed

NCT Number: NCT03590561

Effect of High Caloric Diet on Brain Insulin Sensitivity and Inflammation

Obesity if known to be associated with brain insulin resistance in humans and evidence is rapidly accumulating that brain insulin resistance influences peripheral metabolism, eating behavior and cognition. A reduced insulin response in the brain is found mainly in people with a metabolically unfavorable fat distribution - high visceral fat. Visceral fat produces inflammatory mediators and elevated inflammatory levels are closely linked to insulin resistance. Inflammation of the brain (i.e., neuroinflammation) has been proposed as a possible cause of brain insulin resistance. Interestingly, rodent models of a high calorie diet show that these inflammatory mechanisms occur rapidly in the brain, even prior to weight gain of the animals. Among other things, it has been shown in humans that a short-term increase in calories, especially carbohydrates and fats, reduces insulin sensitivity in the body and increases inflammatory parameters in the blood. Whether a high-calorie diet triggers insulin resistance or inflammation in the human brain is currently unknown.

Aim of study:

The aim of the study is to investigate the effects of a five-day high calorie diet in healthy young male volunteers on peripheral and brain insulin sensitivity as well as on eating behavior, mood and cognition. Brain insulin sensitivity, peripheral metabolism and different behavioral assessments will be evaluated before, 1 week and 2 weeks after high caloric diet.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI 19-24 kg/m2
  • Non smoking
  • normal glucose tolerance during 75g oral glucose tolerance test (OGTT)
  • Exercise less than 2h per week

Exclusion criteria

  • Vegetarians and Vegans
  • Food allergies
  • Working at night
  • Professional Athletes
  • Not removable metal parts in or on the body
  • manifest cardiovascular disease
  • claustrophobia
  • recent surgery (less than 3 months)
  • Simultaneous participation in other studies
  • Acute disease or infection within the last 4 weeks
  • neurological and psychiatric disorders
  • treatment with centrally acting drugs
  • hemoglobin Hb <13g / dl
  • Hypersensitivity to any of the substances used

Treatment and study plan

High caloric diet

Other

After dietary counseling, subjects will receive high caloric snacks for five days.

Primary outcomes

  1. Change in brain insulin sensitivity

    Time frame: Outcome measurements will be assessed at baseline (t0). Then, the 5-day high caloric diet or control dietwill start 5 to 30 days after t0. Outcome measurements will again be assessed on the 6th-7th day and on the 10th-15th day after start of diet.

    fMRI measurement will be performed before and after administration of 160 U of human insulin as nasal spray. Changes in regional activity will be quantified to assess regional brain insulin sensitivity.

  2. Change in quantitative proton density

    Time frame: Outcome measurements will be assessed at baseline (t0). Then, the 5-day high caloric diet or control dietwill start 5 to 30 days after t0. Outcome measurements will again be assessed on the 6th-7th day and on the 10th-15th day after start of diet.

    The inflammatory processes in the brain will be measured through the quantification of the water content by means of proton density imaging.

  3. Change in brain metabolites

    Time frame: Outcome measurements will be assessed at baseline (t0). Then, the 5-day high caloric diet or control dietwill start 5 to 30 days after t0. Outcome measurements will again be assessed on the 6th-7th day and on the 10th-15th day after start of diet.

    The inflammatory processes in the brain will be measured through the determination of brain metabolites by MR spectroscopy

Secondary outcomes

  1. Change in whole-body insulin sensitivity

    Time frame: Outcome measurements will be assessed at baseline (t0). Then, the 5-day high caloric diet or control diet will start 5 to 30 days after t0. Outcome measurements will again be assessed on the 6th-7th day and on the 10th-15th day after start of diet.

    Insulin sensitivity will be estimated from a frequent-sampling 75 g oral glucose tolerance test using the Matsuda formula.

  2. Change in body fat distribution

    Time frame: Outcome measurements will be assessed at baseline (t0). Then, the 5-day high caloric diet or control dietwill start 5 to 30 days after t0. Outcome measurements will again be assessed on the 6th-7th day and on the 10th-15th day after start of diet.

    Body composition will be addressed by whole-body MRI and liver MRS.

  3. Behavioral assessment

    Time frame: Outcome measurements will be assessed at baseline (t0). Then, the 5-day high caloric diet or control dietwill start 5 to 30 days after t0. Outcome measurements will again be assessed on the 6th-7th day and on the 10th-15th day after start of diet.

    Memory function, food reward behavior and mood will be assessed by questionnaires, neuropsychological testing and a snack test.

  4. Change in insulin secretion

    Time frame: Outcome measurements will be assessed at baseline (t0). Then, the 5-day high caloric diet or control dietwill start 5 to 30 days after t0. Outcome measurements will again be assessed on the 6th-7th day and on the 10th-15th day after start of diet.

    Insulin secretion will be estimated from a frequent-sampling 75 g oral glucose tolerance test.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Einfluss Von Hochkalorischer Nahrungsaufnahme Auf Die Insulinsensitivität Des Menschlichen Zentralnervensystems

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2018
Registry last updated
May 20, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.