Diet, Insulin Sensitivity And the Brain

NCT01297738 | Completed

• 1 other identifier: DISAB
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Mellitus Type 2

Keywords

diet manipulation; serotonin; dopamine; insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• Cerebral binding of [123I]FP-CIT to serotonin- and dopamine transporters and correlation with changes in in vivo and ex vivo insulin sensitivity

  Difference in cerebral binding of the radioligand \[123I\]FP-CIT to serotonin- and dopamine transporters before and after dietary manipulations and correlation of cerebral dopamine and serotonin transporter binding with changes in in vivo and ex vivo insulin sensitivity.

  At baseline and after 6 weeks of hypercaloric HFHS or HS diet

Secondary Outcomes (3)

• Abdominal fat mass

  At baseline and after 6 weeks of HFHS or HS hypercaloric diet

• Glucoregularoty hormones

  At baseline and after 6 weeks of hypercaloric HFHS- or HS diet

• Insulin signalling pathways

  At baseline and after 6 weeks of hypercaloric HFHS- or HS diet

Study Arms (5)

Meal size increase with HFHS

EXPERIMENTAL

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®)

Other: Meal size increase with HFHS

Meal size increase with HS

EXPERIMENTAL

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.

Other: Meal size increase with HS

Meal frequency increase with HFHS

EXPERIMENTAL

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.

Other: Meal frequency increase with HFHS

Meal frequency increase with HS

EXPERIMENTAL

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.

Other: Meal frequency increase with HS

Control group

NO INTERVENTION

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

Interventions

Meal size increase with HFHS 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.

Also known as: Nutridrink

Meal size increase with HFHS

Meal size increase with HS 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 size increase with HS

Meal frequency increase with HFHS 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.

Also known as: Nutridrink

Meal frequency increase with HFHS

Meal frequency increase with HS 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.

Meal frequency increase with HS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 24668862 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

• Mireille JM Serlie, Dr

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

  STUDY DIRECTOR

• Karin EM Koopman, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ms

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 17, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

NL (1)