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Completed

NCT Number: NCT00259259

Functional Lipids and Appetite Regulation

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

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg C, Copenhagen, 1958, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SALATRIM

Behavioral

Primary outcomes

  1. Appetite

  2. energy intake

  3. Hormones

Secondary outcomes

  1. Palability

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Danisco

Registry information

Official study title

The Effect of Functional Lipids on Appetite Regulation in Man

Important dates

Study start
2005
Study completion
2005
First posted
Nov 29, 2005
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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