Body Fat Distribution and Fat Metabolism

NCT00475774 | Completed

• 1 other identifier: P7261
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Disease

Outcome Measures

Primary Outcomes (2)

• fatty acid kinetics (in plasma and subcutaneous fat)

  3 weeks

• lipoprotein and adiponectin metabolism

  3 weeks

Secondary Outcomes (2)

• visual analogue scales to evaluate satiety

  3 weeks

• body weight

  3 weeks

Interventions

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

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TNO: lead
• Netherlands: Ministry of Health, Welfare and Sports: collaborator

Study Sites (1)

TNO Quality of Life

Zeist, Netherlands

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases

Interventions

Neprilysin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Antigens, Neoplasm; Antigens; Biological Factors; Biomarkers, Tumor; Biomarkers

Study Officials

• Wilrike Pasman, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 21, 2007
• Study Start: May 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 7, 2008

Record last verified: 2008-04

Locations

NL (1)