Functional Lipids and Appetite Regulation

Obesity Clinical Trial

Official title:

The Effect of Functional Lipids on Appetite Regulation in Man

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259259
• Other study ID #: (KF) 01 275625
• Secondary ID: B218
• Status: Completed
• Phase: N/A
• First received: November 28, 2005
• Last updated: January 20, 2009
• Start date: October 2005
• Est. completion date: December 2005

Study information

• Verified date: September 2006
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

To evaluate the short-term effects of structured lipids on appetite regulation.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• SALATRIM

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, The Royal Veterinary and Agricultural University	Frederiksberg C	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Danisco

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appetite
Primary	energy intake
Primary	Hormones
Secondary	Palability