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Effect of High Caloric Diet on Brain Insulin Sensitivity and Inflammation

U

University Hospital Tuebingen

Status

Completed

Conditions

Obesity
Diabetes Mellitus, Type 2

Treatments

Other: High caloric diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03590561
813/2017BO2

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

Male

Ages

18 to 29 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

32 participants in 2 patient groups

High caloric diet
Experimental group
Description:
Participants will eat 1500 kcal more than their usual diet for five days.
Treatment:
Other: High caloric diet
Control diet
No Intervention group
Description:
Participants will eat regular diet.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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