Body Fat Distribution and Fat Metabolism

April 4, 2008 updated by: TNO

The Effect of Body Fat Distribution on the Physiological Response to a Dietary Fat Intervention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fatty acid kinetics (in plasma and subcutaneous fat)
Time Frame: 3 weeks
3 weeks
lipoprotein and adiponectin metabolism
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
visual analogue scales to evaluate satiety
Time Frame: 3 weeks
3 weeks
body weight
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TNO

Collaborators

Netherlands: Ministry of Health, Welfare and Sports

Investigators

  • Principal Investigator: Wilrike Pasman, PhD, TNO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

May 18, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Estimate)

April 7, 2008

Last Update Submitted That Met QC Criteria

April 4, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P7261

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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