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Completed

NCT Number: NCT01297738

Diet, Insulin Sensitivity And the Brain

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Nutridrink

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 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.

Other names: Nutridrink

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.

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

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

    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.

Secondary outcomes

  1. Abdominal fat mass

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

    Changes in accumulated amount of abdominal (visceral) and liver fat

  2. Glucoregularoty hormones

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

    Changes in glucoregulatory hormones such as glucagon and leptin

  3. Insulin signalling pathways

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

    Changes in insulin signalling pathways in peripheral fat and muscle tissue

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Netherlands Organisation for Scientific Research

Registry information

Official study title

The Effect of Dietary Patterns and Diet Composition on Insulin Sensitivity and Cerebral Dopamine- and Serotonin Transporters

Acronym: DISAB

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2011
Registry last updated
Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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