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The effect of body fat distribution on the physiological response to a dietary fat intervention.

The effect of body fat distribution on the physiological response to a dietary fat intervention. - Body fat distribution and fat metabolism

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31240
Enrollment
12
Registered
2007-06-12
Start date
2007-06-18
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overgewicht/obesitas Obesity overweight

Interventions

Two treatments will be supplied for three weeks, with a wash-out period of at least 3 weeks in-between. Two treatments will be given: three weeks with a fat supplement containing long chain fatty a

Sponsors

TNO
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests; 2. Males aged between 30 - 60 years at Day 01 of the study; 3. Overweight/obese subjects, Body Mass Index (BMI) between 27-35 kg/m2 ; 4. Range in waist-hip ratio as high as possible (preferably below 0.90 or above 0.95); 5. Regular Dutch eating habits as assessed by P7261 F02 and used to consume margarine; 6. Non restrained eater, defined as a score of

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study; 2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances; 3. Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder; 4. Use of medication that may influence appetite, and/or sensory functioning within 14 days before day 01, except paracetamol; 5. Smoking; 6. Alcohol consumption (> 28 units/week); 7. Contra-indication to MRI scanning (claustrophobia; pacemakers and defibrillators; nerve stimulators; intracranial clips; intraorbital or intraocular metallic fragments; cochlear implants; ferromagnetic implants; presence of any other metal object e.g. in the mouth); 8. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening; 9. Reported slimming or medically prescribed diet; 10. Reported vegan, vegetarian or macrobiotic; 11. Recent blood donation (

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: On the last day (day 21 and day 63) of each treatment period subjects will come to the metabolic ward of 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. The primary objective of the study is to investigate the effect of chain length of the fatty acid consumed on kinetics of fat metabolism and fat disposition (centrally or subcutaneously).

Secondary

MeasureTime frame
2. leucine tracers in blood as a measure for lipoprotein synthesis and degeneration ; 3. changes in fat tissue characteristue due to the intervention; 4. satiety hormones and scores.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)