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Sponsors and Collaborators: |
TNO Quality of Life Netherlands: Ministry of Health, Welfare and Sports |
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Information provided by: | TNO Quality of Life |
ClinicalTrials.gov Identifier: | NCT00242021 |
The objective of the study is to investigate the effect of fatty acid composition of a fat supplement:
Condition | Intervention |
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Obesity |
Behavioral: Fatty acid composition of a margarine (spread) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Fatty Acid Composition of a Fat Supplement on Energy Intake, Satiety and Fat Metabolism in Lean and Obese Men |
Estimated Enrollment: | 20 |
Study Start Date: | October 2005 |
Study Completion Date: | December 2005 |
Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
One of the physiological factors regulating the food intake pattern is satiety. Satiety is defined as the absence of ingestive motivation, which ends when the next meal is initiated (Blundell et al., 1996). Food intake affects a number of physiological objective parameters in blood known to be involved in signaling satiety, such as glucose (Melanson et al, 1999; Chapman et al, 1999; Campfield et al, 1996), insulin (Speechly et al, 2000) and cholecystokinin (CCK) (Gutzwiller et al., 2000; Beglinger et al., 2001; French et al., 2000; Degen et al., 2001; Burton-Freemanet al., 2002, 2004). More recently, the gastric hormone ghrelin was identified as a marker for hunger and meal initiation (De Graaf et al, 2004). Ghrelin concentrations in blood were highly correlated with subjective measures of appetite. PYY, a gut hormone produced postprandially, will be measured in this study because it has been mentioned that this hormone inhibits food intake (Batterham et al., 2003). The baseline level of PYY is lower in obese subjects than in lean subjects. The two groups different in body weight will therefore show different baseline levels, and perhaps different curves as well.
Humans do not only eat in response to a metabolic or physiological need. Humans also respond to a significant extend to other internal subjective and emotional signals (cues). The exact relations between the physiological internal signals and subjective and emotional internal signals are not known.
Besides also external and social factors modulate physiological-derived hunger and satiety signals.
In the present clinical trial, the effect of fatty acid composition of a fat supplement will be studied on hunger and satiety. In the supplement a mixture of fatty acids known for their satiating effect will be tested and will be compared with a control supplement containing fatty acids normally consumed with breakfast.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands, Utrecht | |
TNO Quality of Life | |
Zeist, Utrecht, Netherlands, 3704 HE |
Principal Investigator: | Wilrike Pasman, PhD | TNO Quality of Life |
Responsible Party: | TNO Quality of Life ( Dr. W.J. Pasman ) |
Study ID Numbers: | P6468 |
Study First Received: | October 18, 2005 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00242021 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Satiety, ad libitum food intake, fatty acids, hormones |
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Hormones |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |