ObesityNCT00242021
The Effect of Fatty Acid Composition on Energy Intake and Satiety
A study testing Fatty acid composition of a margarine (spread) in people with Obesity, run by TNO at 1 site in Netherlands.
Trial summary
The objective of the study is to investigate the effect of fatty acid composition of a fat supplement: 1. acutely (after single intake) on subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes; 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fatty acid composition of a margarine (spread)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests;
- Males aged between 18 - 60 years at Day 01 of the study;
- Normal weight subjects and overweight/obese subjects, Body Mass Index (BMI) will be at least two units different between the heaviest normal weight and the lightest overweight subject, the largest contrast between groups will be aimed at, e.g normal weight BMI between 18 and 25 kg/m2 and overweight/obese BMI between 27.5-35 kg/m2;
- Regular Dutch eating habits as assessed by P6468 F02 and used to breakfast consumption;
- Non restrained eater, defined as a score of < 2.5 in lean and <3.25 in obese men on the Dutch Eating Behaviour Questionnaire;
- Appropriate veins for blood sampling/cannula insertion according to TNO;
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- Voluntary participation;
- Having given written informed consent;
- Willing to comply with the study procedures;
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years;
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Who cannot join
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study;
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances;
- Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder or hypertension;
- Use of medication that may influence appetite, and/or sensory functioning within 14 days before day 01, except paracetamol;
- Allergic reaction to chlorhexidine and/or lidocaine (anaesthetic solution);
- Having a history of or current alcohol consumption of more than 28 units/week;
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- Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening;
- Mental or physical status that is incompatible with the proper conduct of the study;
- Reported chronic and/or excessive mental or physical strain;
- Reported slimming or medically prescribed diet;
- Reported vegan, vegetarian or macrobiotic;
- Use food supplement(s) and not willing to stop intake after the medical screening;
- Smoking;
- Claustrophobia;
- Practicing heavy physical exercise > 5 hours/week;
- Recent blood donation (<1 month prior to the start of the study) and not willing to give up blood donation during the study;
- Personnel of TNO Quality of Life, their partner and their first and second degree relatives;
- Not having a general practitioner;
- Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatty Acid Composition of a Fat Supplement on Energy Intake, Satiety and Fat Metabolism in Lean and Obese Men
The objective of the study is to investigate the effect of fatty acid composition of a fat supplement:
- acutely (after single intake) on subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes;
- in the long-term (after one week) on (regulators of) fat tissue metabolism.
Read the detailed description
One of the physiological factors regulating the food intake pattern is satiety. Satiety is defined as the absence of ingestive motivation, which ends when the next meal is initiated (Blundell et al., 1996). Food intake affects a number of physiological objective parameters in blood known to be involved in signaling satiety, such as glucose (Melanson et al, 1999; Chapman et al, 1999; Campfield et al, 1996), insulin (Speechly et al, 2000) and cholecystokinin (CCK) (Gutzwiller et al., 2000; Beglinger et al., 2001; French et al., 2000; Degen et al., 2001; Burton-Freemanet al., 2002, 2004). More recently, the gastric hormone ghrelin was identified as a marker for hunger and meal initiation (De Graaf et al, 2004). Ghrelin concentrations in blood were highly correlated with subjective measures of appetite. PYY, a gut hormone produced postprandially, will be measured in this study because it has been mentioned that this hormone inhibits food intake (Batterham et al., 2003). The baseline level of PYY is lower in obese subjects than in lean subjects. The two groups different in body weight will therefore show different baseline levels, and perhaps different curves as well.
Humans do not only eat in response to a metabolic or physiological need. Humans also respond to a significant extend to other internal subjective and emotional signals (cues). The exact relations between the physiological internal signals and subjective and emotional internal signals are not known. Besides also external and social factors modulate physiological-derived hunger and satiety signals.
In the present clinical trial, the effect of fatty acid composition of a fat supplement will be studied on hunger and satiety. In the supplement a mixture of fatty acids known for their satiating effect will be tested and will be compared with a control supplement containing fatty acids normally consumed with breakfast.
- Conditions
- Obesity
- Being tested
- Fatty acid composition of a margarine (spread)
- Keywords
- Satiety, ad libitum food intake, fatty acids, hormones
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatty acid composition of a margarine (spread)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes
Secondary outcomes (1)
After one week supplementation the effect on (regulators of) fat tissue metabolism will be examined.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionDec 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Welfare and Sport
- Investigators
- Wilrike Pasman, PhD, Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242021
- Sponsor's protocol ID
- P6468
- Status last verified
- Dec 2022
- First submitted
- 18 Oct 2005
- Last updated
- 16 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Acid Composition of a Fat Supplement on Energy Intake, Satiety and Fat Metabolism in Lean and Obese Men
- ClinicalTrials.gov ID
- NCT00242021
- Acronym / sponsor ID
- P6468
- Conditions
- Obesity
- Keywords
- Satiety, ad libitum food intake, fatty acids, hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Ministry of Health, Welfare and Sport
- Study start
- Oct 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 19 Oct 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.
The objective of the study is to investigate the effect of fatty acid composition of a fat supplement:
- acutely (after single intake) on subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes;
- in the long-term (after one week) on (regulators of) fat tissue metabolism.
Detailed description
One of the physiological factors regulating the food intake pattern is satiety. Satiety is defined as the absence of ingestive motivation, which ends when the next meal is initiated (Blundell et al., 1996). Food intake affects a number of physiological objective parameters in blood known to be involved in signaling satiety, such as glucose (Melanson et al, 1999; Chapman et al, 1999; Campfield et al, 1996), insulin (Speechly et al, 2000) and cholecystokinin (CCK) (Gutzwiller et al., 2000; Beglinger et al., 2001; French et al., 2000; Degen et al., 2001; Burton-Freemanet al., 2002, 2004). More recently, the gastric hormone ghrelin was identified as a marker for hunger and meal initiation (De Graaf et al, 2004). Ghrelin concentrations in blood were highly correlated with subjective measures of appetite. PYY, a gut hormone produced postprandially, will be measured in this study because it has been mentioned that this hormone inhibits food intake (Batterham et al., 2003). The baseline level of PYY is lower in obese subjects than in lean subjects. The two groups different in body weight will therefore show different baseline levels, and perhaps different curves as well.
Humans do not only eat in response to a metabolic or physiological need. Humans also respond to a significant extend to other internal subjective and emotional signals (cues). The exact relations between the physiological internal signals and subjective and emotional internal signals are not known. Besides also external and social factors modulate physiological-derived hunger and satiety signals.
In the present clinical trial, the effect of fatty acid composition of a fat supplement will be studied on hunger and satiety. In the supplement a mixture of fatty acids known for their satiating effect will be tested and will be compared with a control supplement containing fatty acids normally consumed with breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests;
- Males aged between 18 - 60 years at Day 01 of the study;
- Normal weight subjects and overweight/obese subjects, Body Mass Index (BMI) will be at least two units different between the heaviest normal weight and the lightest overweight subject, the largest contrast between groups will be aimed at, e.g normal weight BMI between 18 and 25 kg/m2 and overweight/obese BMI between 27.5-35 kg/m2;
- Regular Dutch eating habits as assessed by P6468 F02 and used to breakfast consumption;
- Non restrained eater, defined as a score of < 2.5 in lean and <3.25 in obese men on the Dutch Eating Behaviour Questionnaire;
Key exclusion criteria (19 listed)
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study;
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances;
- Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder or hypertension;
- Use of medication that may influence appetite, and/or sensory functioning within 14 days before day 01, except paracetamol;
- Allergic reaction to chlorhexidine and/or lidocaine (anaesthetic solution);
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 |
|---|---|---|
| Fatty acid composition of a margarine (spread) | Behavioural | – |
Primary outcome
Subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes
1 secondary outcome
After one week supplementation the effect on (regulators of) fat tissue metabolism will be examined.
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 16 Dec 2022.
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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.
Wilrike Pasman, PhD principal investigator
TNO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatty acid composition of a margarine (spread) in people with Obesity, run by TNO at 1 site in Netherlands.
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 11 inclusion and 19 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 16 Dec 2022. 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 Netherlands. 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?
Subjective and objective measurements of hunger, satiety and wellness, on energy intake, and postprandial hormonal changes. 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 16 Dec 2022.