ObesityNCT03590561
Effect of High Caloric Diet on Brain Insulin Sensitivity and Inflammation
A study testing High caloric diet in people with Obesity and Diabetes Mellitus, Type 2, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- High caloric diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jun 2018to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 19-24 kg/m2
- Non smoking
- normal glucose tolerance during 75g oral glucose tolerance test (OGTT)
- Exercise less than 2h per week
Who cannot join
- Vegetarians and Vegans
- Food allergies
- Working at night
- Professional Athletes
- Not removable metal parts in or on the body
- manifest cardiovascular disease
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
About this study
Official title: Einfluss Von Hochkalorischer Nahrungsaufnahme Auf Die Insulinsensitivität Des Menschlichen Zentralnervensystems
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
- Being tested
- High caloric diet
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High caloric dietOther
After dietary counseling, subjects will receive high caloric snacks for five days.
| Study group | Role | What they receive |
|---|---|---|
| High caloric diet | Experimental | Participants will eat 1500 kcal more than their usual diet for five days. Receives: Other: High caloric diet |
| Control diet | No intervention | Participants will eat regular diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain insulin sensitivity
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.
Measured: 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.
Change in quantitative proton density
The inflammatory processes in the brain will be measured through the quantification of the water content by means of proton density imaging.
Measured: 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.
Change in brain metabolites
The inflammatory processes in the brain will be measured through the determination of brain metabolites by MR spectroscopy
Measured: 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.
Secondary outcomes (4)
Change in whole-body insulin sensitivity
Insulin sensitivity will be estimated from a frequent-sampling 75 g oral glucose tolerance test using the Matsuda formula.
Measured: 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.
Change in body fat distribution
Body composition will be addressed by whole-body MRI and liver MRS.
Measured: 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.
Behavioral assessment
Memory function, food reward behavior and mood will be assessed by questionnaires, neuropsychological testing and a snack test.
Measured: 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.
Change in insulin secretion
Insulin secretion will be estimated from a frequent-sampling 75 g oral glucose tolerance test.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start13 Jun 2018
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590561
- Sponsor's protocol ID
- 813/2017BO2
- Status last verified
- May 2020
- First submitted
- 14 Jun 2018
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not able to share individual participant data due to data protection restraints.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Von Hochkalorischer Nahrungsaufnahme Auf Die Insulinsensitivität Des Menschlichen Zentralnervensystems
- ClinicalTrials.gov ID
- NCT03590561
- Acronym / sponsor ID
- 813/2017BO2
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High caloric diet | Experimental | Other: High caloric dietParticipants will eat 1500 kcal more than their usual diet for five days. |
| Control diet | No intervention | –Participants will eat regular diet. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 19-24 kg/m2
Key exclusion criteria (14 listed)
- Vegetarians and Vegans
- Food allergies
- Working at night
- Professional Athletes
- Not removable metal parts in or on the body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High caloric dietAfter dietary counseling, subjects will receive high caloric snacks for five days. | Other | High caloric diet |
Primary outcome
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.
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.
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
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No. We will not able to share individual participant data due to data protection restraints.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High caloric diet in people with Obesity and Diabetes Mellitus, Type 2, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.