Body Fat Distribution and Fat Metabolism

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475774
• Other study ID #: P7261
• Status: Completed
• Phase: N/A
• First received: May 18, 2007
• Last updated: April 4, 2008
• Start date: May 2007
• Est. completion date: September 2007

Study information

• Verified date: April 2008
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Obesity

Intervention

Behavioral:
• Long-chain (C18:2) and medium chain fatty acid (C8 and C10).

Locations

Country	Name	City	State
Netherlands	TNO Quality of Life	Zeist

Sponsors (2)

Lead Sponsor	Collaborator
TNO	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatty acid kinetics (in plasma and subcutaneous fat)		3 weeks
Primary	lipoprotein and adiponectin metabolism		3 weeks
Secondary	visual analogue scales to evaluate satiety		3 weeks
Secondary	body weight		3 weeks