Body Fat Distribution and Fat Metabolism
Primary Purpose
Obesity, Metabolic Disease
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Long-chain (C18:2) and medium chain fatty acid (C8 and C10).
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Healthy
- Males aged between 30 - 60 years at Day 01 of the study
- Body Mass Index (BMI) between 27-35 kg/m2
- Range in waist-hip ratio as high as possible (preferably <0.90 or >0.95)
- Regular Dutch eating habits and used to consume margarine;
- Non restrained eater
- Voluntary participation
- Having given written informed consent
- Willing to comply with the study procedures
- Agree to be informed about chance findings of pathology found with the MRI
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion Criteria:
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Having a history of medical or surgical events that may significantly affect the study outcome
- Use of medication that may influence appetite, and/or sensory functioning
- Smoking
- Alcohol consumption (> 28 units/week)
- Contra-indication to MRI scanning
- Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- Reported slimming or medically prescribed diet
- Reported vegan, vegetarian or macrobiotic
- Recent blood donation (<1 month prior to the start of the study)
- Not willing to give up blood donation during the study
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his health to and from his general practitioner.
Sites / Locations
- TNO Quality of Life
Outcomes
Primary Outcome Measures
fatty acid kinetics (in plasma and subcutaneous fat)
lipoprotein and adiponectin metabolism
Secondary Outcome Measures
visual analogue scales to evaluate satiety
body weight
Full Information
NCT ID
NCT00475774
First Posted
May 18, 2007
Last Updated
April 4, 2008
Sponsor
TNO
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
1. Study Identification
Unique Protocol Identification Number
NCT00475774
Brief Title
Body Fat Distribution and Fat Metabolism
Official Title
The Effect of Body Fat Distribution on the Physiological Response to a Dietary Fat Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
TNO
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of the study is to examine the effect of body fat distribution on the physiological response to a dietary fat intervention. Physiological response will be evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance).
Secondary objectives are targeted protein production (apoB and adiponectin). Examination of the effect of chain length of the dietary fatty acids on fat tissue characteristics and the effect of chain length on satiety, will be studied as well.
Detailed Description
Rationale: The increased prevalence of obesity and the related risk for metabolic diseases have resulted in increased interest in prevention of obesity through life-style interventions. The site of fat storage (visceral or subcutaneous) is considered to be relevant in terms of risk for metabolic disorders. The type of fat consumed may determine storage in either fat storage site and hence be related to metabolic disorders. Long-chain fatty acids have been suggested to be preferentially targeted to subcutaneous fat, whereas medium chain fatty acids may preferably be targeted to the visceral fat depot.
Objective: The primary objective is to examine the effect of body fat distribution on the physiological response to a dietary fat intervention. Physiological response will be evaluated as fatty acid kinetics (plasma and subcutaneous fat appearance), targeted protein production (apoB and adiponectin) and satiety.
Study design: The study is designed as a randomized, double-blind, cross-over trial. Two treatments will be supplied for three weeks, with a wash-out period of at least 3 weeks in-between.
Study population: Twelve apparently healthy overweight/obese men (30-60 years of age) with a BMI of 27-35 kg.m-2 (6 upper body obese (high WHR) en 6 lower body obese (low WHR)).
Intervention: Three weeks intervention with a fat replacement containing long chain fatty acids and three weeks intervention with a fat replacement containing medium chain fatty acids. The margarines will replace the normally consumed margarine. Consumption will take place with breakfast, lunch and dinner.
Main study parameters/endpoints: On the last day of each treatment period subjects will come to TNO for evaluation of the effect of the dietary intervention on fat metabolism and fat tissue. This will be examined with stable isotope techniques and fat biopsies of subcutaneous fat. At baseline subjects will have a total body scan in the MRI to characterize body fat.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Long-chain (C18:2) and medium chain fatty acid (C8 and C10).
Primary Outcome Measure Information:
Title
fatty acid kinetics (in plasma and subcutaneous fat)
Time Frame
3 weeks
Title
lipoprotein and adiponectin metabolism
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
visual analogue scales to evaluate satiety
Time Frame
3 weeks
Title
body weight
Time Frame
3 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
Males aged between 30 - 60 years at Day 01 of the study
Body Mass Index (BMI) between 27-35 kg/m2
Range in waist-hip ratio as high as possible (preferably <0.90 or >0.95)
Regular Dutch eating habits and used to consume margarine;
Non restrained eater
Voluntary participation
Having given written informed consent
Willing to comply with the study procedures
Agree to be informed about chance findings of pathology found with the MRI
Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion Criteria:
Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
Having a history of medical or surgical events that may significantly affect the study outcome
Use of medication that may influence appetite, and/or sensory functioning
Smoking
Alcohol consumption (> 28 units/week)
Contra-indication to MRI scanning
Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
Reported slimming or medically prescribed diet
Reported vegan, vegetarian or macrobiotic
Recent blood donation (<1 month prior to the start of the study)
Not willing to give up blood donation during the study
Not having a general practitioner
Not willing to accept information-transfer concerning participation in the study, or information regarding his health to and from his general practitioner.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilrike Pasman, PhD
Organizational Affiliation
TNO
Official's Role
Principal Investigator
Facility Information:
Facility Name
TNO Quality of Life
City
Zeist
Country
Netherlands
12. IPD Sharing Statement
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Body Fat Distribution and Fat Metabolism
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