Effect of High Caloric Diet on Brain Insulin Sensitivity and Inflammation

NCT ID: NCT03590561

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-13
• Study Completion Date: 2020-03-10

Brief Summary

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.

Conditions

Obesity; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

High caloric diet

Participants will eat 1500 kcal more than their usual diet for five days.

Group Type: EXPERIMENTAL

High caloric diet

Intervention Type: OTHER

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

Control diet

Participants will eat regular diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High caloric diet

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Tuebingen, Department of Internal Medicine IV

Tübingen, , Germany

Countries

Germany

Other Identifiers

813/2017BO2

Identifier Type: -

Identifier Source: org_study_id