ObesityNCT00259259
Functional Lipids and Appetite Regulation
A study testing SALATRIM in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
To evaluate the short-term effects of structured lipids on appetite regulation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- SALATRIM
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2005to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males
- Normal weigh, e.i. BMI between 18,5-25 kg/m2
- age 18-40 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg C, Copenhagen, 1958
About this study
Official title: The Effect of Functional Lipids on Appetite Regulation in Man
To evaluate the short-term effects of structured lipids on appetite regulation.
Read the 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
- Conditions
- Obesity
- Being tested
- SALATRIM
- Keywords
- Appetite regulation, Hormones, Energy intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SALATRIMBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite
energy intake
Hormones
Secondary outcomes (1)
Palability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startOct 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danisco
- Investigators
- Arne Astrup, Proffessor, Principal investigator, Department of human nutrition, The Royal Veterinary and Agricultural University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259259
- Sponsor's protocol ID
- (KF) 01 275625
- Other IDs
- B218
- Status last verified
- Sep 2006
- First submitted
- 28 Nov 2005
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Lipids on Appetite Regulation in Man
- ClinicalTrials.gov ID
- NCT00259259
- Acronym / sponsor ID
- (KF) 01 275625
- Conditions
- Obesity
- Keywords
- Appetite regulation, Hormones, Energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danisco
- Study start
- Oct 2005
- Study completion
- Dec 2005
- First posted
- 29 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males
- Normal weigh, e.i. BMI between 18,5-25 kg/m2
- age 18-40 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SALATRIM | Behavioural | – |
Primary outcome
Appetite
energy intake
Hormones
1 secondary outcome
Palability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Proffessor principal investigator
Department of human nutrition, The Royal Veterinary and Agricultural University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SALATRIM in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.