Clinical trial NCT00259259: Functional Lipids and Appetite Regulation
Official title: The Effect of Functional Lipids on Appetite Regulation in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Appetite regulation
Hormones
Energy intake
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danisco
First posted: 2005-11-29
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

* healthy males
* Normal weigh, e.i. BMI between 18,5-25 kg/m2
* age 18-40 years

Exclusion Criteria:

* donation of blood 3 monhts prior or during the study
* gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease
* smoking
* consumption of more than 21 alcoholic drinks/week
* elite athletes
* on mediation
* diet supplements

Primary outcomes:
measure: Appetite
measure: energy intake
measure: Hormones
Secondary outcomes:
measure: Palability
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Human Nutrition, The Royal Veterinary and Agricultural University
state: Copenhagen
Study officials:
affiliation: Department of human nutrition, The Royal Veterinary and Agricultural University
name: Arne Astrup, Proffessor
role: PRINCIPAL_INVESTIGATOR
References: