Diet, Insulin Sensitivity And the Brain (DISAB)
This study has been completed.
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator:
Netherlands Organisation for Scientific Research
Information provided by (Responsible Party):
K.E.M. Koopman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01297738
First received: February 16, 2011
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Diabetes Mellitus Type 2 |
Other: Meal size increase with HFHS Other: Meal size increase with HS Other: Meal frequency increase with HFHS Other: Meal frequency increase with HS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | The Effect of Dietary Patterns and Diet Composition on Insulin Sensitivity and Cerebral Dopamine- and Serotonin Transporters |
Resource links provided by NLM:
Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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 Outcome Measures:
- Abdominal fat mass [ Time Frame: At baseline and after 6 weeks of HFHS or HS hypercaloric diet ] [ Designated as safety issue: No ]Changes in accumulated amount of abdominal (visceral) and liver fat
- Glucoregularoty hormones [ Time Frame: At baseline and after 6 weeks of hypercaloric HFHS- or HS diet ] [ Designated as safety issue: No ]Changes in glucoregulatory hormones such as glucagon and leptin
- Insulin signalling pathways [ Time Frame: At baseline and after 6 weeks of hypercaloric HFHS- or HS diet ] [ Designated as safety issue: No ]Changes in insulin signalling pathways in peripheral fat and muscle tissue
| Enrollment: | 39 |
| Study Start Date: | February 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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®)
|
Other: 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.
Other Name: Nutridrink
|
|
Experimental: 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.
|
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.
|
|
Experimental: 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.
|
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.
Other Name: Nutridrink
|
|
Experimental: 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.
|
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.
|
|
No Intervention: Control group
Subjects will not follow any diet but their own ad-libitum, healty diet.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297738
Locations
| Netherlands | |
| Academic Medical Center | |
| Amsterdam, Noord-Holland, Netherlands, 1105 AZ | |
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Netherlands Organisation for Scientific Research
Investigators
| Study Director: | Mireille JM Serlie, Dr | Academic Medical Center, Amsterdam |
| Principal Investigator: | Karin EM Koopman, MD | Academic Medical Center, Amsterdam |
More Information
No publications provided
| Responsible Party: | K.E.M. Koopman, ms, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| ClinicalTrials.gov Identifier: | NCT01297738 History of Changes |
| Other Study ID Numbers: | DISAB |
| Study First Received: | February 16, 2011 |
| Last Updated: | January 23, 2013 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
diet manipulation serotonin dopamine insulin sensitivity |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Insulin Resistance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Hyperinsulinism Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013