Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 9:27 AM
Study NCT ID:
NCT00259259
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2005-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Lipids and Appetite Regulation
Sponsor:
University of Copenhagen
Organization:
Study Overview
Official Title:
The Effect of Functional Lipids on Appetite Regulation in Man
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the short-term effects of structured lipids on appetite regulation.
Detailed Description:
Background Obesity is a major health problem worldwide, and it is a risk factor for several chronic disorders. Even small changes in energy intake, leading to a positive balance may lead to weight gain over time. Thus, slight modifications in food intake, such as the inclusion of foods that effect energy balance, may prevent weight gain and even facilitate weight loss. Replacing dietary fat with low-calorie fat (LCF), such as modified triglycerides with medium and long chained PUFA.may be an efficient way to reduce body fat.
Bray et al. (2002) has shown a sustained weight loss of \~6 kg over a 9 month period where one-third of a fat-reduced diet (25% fat) was replaced by olestra. This weight loss can not solely be explained by the decreased caloric content of olestra. Thus, inhibition of appetite leading to lower food intake, may be a potential mechanism of the observed weight loss.
A reduced absorption of LCF leaves undigested fatty acids in the middle and lower intestine, which may generate increased feelings of satiety and decrease caloric intake due to regulating peptides and hormones such (CCK, GLP-1, etc.). In addition, intraduodenal fatty acids may also promote distension of the stomach and distension of the intestine, which are well-known gastrointestinal signals controlling mechanisms for food intake.
Taken together, in addition to the acute reduction in caloric intake, LCF may encourage a gastrointestinal hormone response promoting beneficial effects on appetite regulation and energy balance.
Aims To evaluate the short-term effects of LCF on
Primary:
* Appetite sensations after a meal (VAS)
* Postprandiel secretion of appetite regulating hormones
* Ad libitum caloric intake 4,5-h subsequent to a fixed meal
Secondary:
• Palatability of the test meal
Bray et al. (2002) has shown a sustained weight loss of \~6 kg over a 9 month period where one-third of a fat-reduced diet (25% fat) was replaced by olestra. This weight loss can not solely be explained by the decreased caloric content of olestra. Thus, inhibition of appetite leading to lower food intake, may be a potential mechanism of the observed weight loss.
A reduced absorption of LCF leaves undigested fatty acids in the middle and lower intestine, which may generate increased feelings of satiety and decrease caloric intake due to regulating peptides and hormones such (CCK, GLP-1, etc.). In addition, intraduodenal fatty acids may also promote distension of the stomach and distension of the intestine, which are well-known gastrointestinal signals controlling mechanisms for food intake.
Taken together, in addition to the acute reduction in caloric intake, LCF may encourage a gastrointestinal hormone response promoting beneficial effects on appetite regulation and energy balance.
Aims To evaluate the short-term effects of LCF on
Primary:
* Appetite sensations after a meal (VAS)
* Postprandiel secretion of appetite regulating hormones
* Ad libitum caloric intake 4,5-h subsequent to a fixed meal
Secondary:
• Palatability of the test meal
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| B218 | None | None | View |