Diet, Insulin Sensitivity And the Brain

NCT ID: NCT01297738

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-07-31

Brief Summary

Obesity and insulin resistance may be in part explained by an altered reward system with changes in the serotonin/dopamine system. These changes might be caused by changes in dietary habits, especially by an increased intake of liquid sugar and an increase in meal frequency. The investigators hypothesize that increasing meal frequency compared to increasing meal size and when consuming a hypercaloric high-sugar diet (HS) compared to a hypercaloric high-fat-high-sugar diet (HFHS) will result in a reduction in cerebral serotonin and dopamine transporters and in a more prominent increase in insulin resistance. In addition, the investigators hypothesize that the changes in insulin sensitivity will be independent of changes in abdominal (visceral) and liver fat and that changes in insulin sensitivity due to the dietary manipulation will co-occur with changes in insulin signaling pathways in peripheral fat and muscle tissue.

Detailed Description

Lean, healthy, young men will follow a hypercaloric HF- or HFHS diet for 6 weeks. Before and after the dietary intervention, the investigators will perform a SPECT-scan for serotonin and dopamine transporters with the radioligand [123I]FP-CIT, administered intravenously. The investigators will also perform a structural MRI for localization. Furthermore the investigators will perform a liver MRS and abdominal MRI for liver fat- and abdominal visceral fat measurement. The investigators will also perform a euglycemic, hyperinsulinemic clamp to measure insulin sensitivity and muscle- and fat biopsies to examine changes in insulin signaling pathways and fat metabolism. After the hypercaloric diet subjects will follow a hypocaloric diet until their weight is back to baseline.

Conditions

Obesity; Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Meal size increase with HFHS

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a liquid meal which is high in fat and sugar (Nutridrink®)

Group Type: EXPERIMENTAL

Meal size increase with HFHS

Intervention Type: OTHER

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a high-fat, high-sugar liquid medical food supplement (Nutridrink®). Subjects consume the Nutridrink® with their meals, which results in an increase in meal size.

Meal size increase with HS

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume this caloric surplus with their meals, which results in an increase in meal size.

Group Type: EXPERIMENTAL

Meal size increase with HS

Intervention Type: OTHER

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume these sugar-sweetened beverages with their meals, which results in an increase in meal size.

Meal frequency increase with HFHS

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a liquid meal which has a high fat and sugar content(Nutridrink®). Subjects consume the Nutridrink 3 times a day in between meals. which results in an increase in meal frequency.

Group Type: EXPERIMENTAL

Meal frequency increase with HFHS

Intervention Type: OTHER

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a high-fat, high-sugar liquid medical food supplement (Nutridrink®). Subjects consume the Nutridrink® 3 times a day in between meals, which results in an increase in meal frequency.

Meal frequency increase with HS

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume these sugar-sweetened beverages 3 times a day in between meals, which results in an increase in meal frequency.

Group Type: EXPERIMENTAL

Meal frequency increase with HS

Intervention Type: OTHER

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume these sugar-sweetened beverages 3 times a day in between meals, which results in an increase in meal frequency.

Control group

Subjects will not follow any diet but their own ad-libitum, healty diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meal size increase with HFHS

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a high-fat, high-sugar liquid medical food supplement (Nutridrink®). Subjects consume the Nutridrink® with their meals, which results in an increase in meal size.

Intervention Type: OTHER

Meal size increase with HS

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume these sugar-sweetened beverages with their meals, which results in an increase in meal size.

Intervention Type: OTHER

Meal frequency increase with HFHS

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a high-fat, high-sugar liquid medical food supplement (Nutridrink®). Subjects consume the Nutridrink® 3 times a day in between meals, which results in an increase in meal frequency.

Intervention Type: OTHER

Meal frequency increase with HS

On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume these sugar-sweetened beverages 3 times a day in between meals, which results in an increase in meal frequency.

Intervention Type: OTHER

Other Intervention Names

Nutridrink; Nutridrink

Eligibility Criteria

Inclusion Criteria

• BMI 19-26 kg/m2
• Age 18-40 years old
• Male gender
• Caucasian
• Stable weight 3 months prior to start study participation

Exclusion Criteria

• Abnormal oral glucose tolerance test (OGTT)
• Lipid disorders, renal disorders, thyroid disorders, elevated liver enzymes
• Use of medication
• Use of alcohol > 3/day
• Use of ecstasy, amphetamines or cocaine
• Smoking
• History of eating disorder or psychiatric disorder
• Any medical condition, intensive sports ( >3 times/week), shift work

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Netherlands Organisation for Scientific Research

OTHER_GOV

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

K.E.M. Koopman

ms

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mireille JM Serlie, Dr

Role: STUDY_DIRECTOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Karin EM Koopman, MD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

Academic Medical Center

Amsterdam, North Holland, Netherlands

Countries

Netherlands

References

Koopman KE, Caan MW, Nederveen AJ, Pels A, Ackermans MT, Fliers E, la Fleur SE, Serlie MJ. Hypercaloric diets with increased meal frequency, but not meal size, increase intrahepatic triglycerides: a randomized controlled trial. Hepatology. 2014 Aug;60(2):545-53. doi: 10.1002/hep.27149. Epub 2014 May 13.

Reference Type: DERIVED

PMID: 24668862 (View on PubMed)

Other Identifiers

DISAB

Identifier Type: -

Identifier Source: org_study_id