Appetite; Lack or Loss, Nonorganic OriginSTABLENCT02582723
Acute Effect of Cheeses With Different Energy Content on Appetite
A study testing High protein/high fat hard cheese, High protein/low fat hard cheese and Low protein/high fat creme cheese in people with Appetite; Lack or Loss, Nonorganic Origin, run by University of Copenhagen at 1 site in Denmark.
Trial summary
A double-blind, randomised crossover design will be employed with three experimental conditions; High protein/high fat hard cheese, high protein/low fat hard cheese, and low protein/high fat creme cheese served at least 7 days apart. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite; Lack or Loss, Nonorganic Origin
- What is being tested?
- High protein/high fat hard cheese, High protein/low fat hard cheese and Low protein/high fat creme cheese
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Nov 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who have provided written informed consent
- Healthy men and women
- Ages between 18 and 60 years
- BMI between 20.0-31.9 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
- Regular menstrual periods (women only)
Who cannot join
- Participants not able to comply with the study protocol, including consumption of the specific study foods
- Significant health problems as judged by the investigator
- Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator
- Pregnant, planning to become pregnant within the next 4 weeks or breastfeeding (women only)
- History of anaphylaxis to food
- Any known food allergies or food intolerance likely to affect the present study
Show all 13Show fewer
- Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes)
- Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
- Significant changes in physical activity patterns in the past 4 weeks or intention to change during the study as judged by the investigator
- Significant change in diet in the past 4 weeks or intention to change the diet during the study as judged by the investigator
- Use of systemic or local treatment likely to interfere with evaluation of the study parameters as judged by the investigator
- Participants who work in appetite or feeding related areas
- Post-menopausal (women only)
Trial locations and contacts
1 site in 1 country.
About this study
A double-blind, randomised crossover design will be employed with three experimental conditions; High protein/high fat hard cheese, high protein/low fat hard cheese, and low protein/high fat creme cheese served at least 7 days apart. After having successfully completed screening procedures, eligible participants will be invited for three separate test days. The test days should be performed at least 7 days apart; however for logistical reasons 4 days can be accepted. On the test days, the products will be provided in a randomized order, and subjective appetite ratings will be measured every 30 minutes for the following 3 hours. Subsequent energy intake will be measured by an ad libitum meal 3 hours following serving of the breakfast meal.
Read the detailed description
Participants will arrive at the laboratory after an overnight fast (at least from 10:00 pm) with the use of the least strenuously transportation possible (no bicycling or long distance walk). In addition, the preceding two days (48h) before each of the study days; no intensive physical activity or consumption of alcohol is allowed in order to obtain standardization of the participants.
Once settled into an individual feeding cubicle, visual analogue scales (VAS) will be completed for the measurement of fasting appetite levels. A standardized fixed breakfast meal (providing approximately 20% of total estimated energy need) consisting of 80 g. cheese with bread, orange juice and a cup (125 mL) of coffee/the/water (milk is not allowed). The amounts of bread (70.5 g.) and juice (132 g.) are calculated with Babybel original as reference, and these amounts for bread and juice are kept constant regardless of the cheese provided. The cheese will be served blinded together with the bread, and the brand of cheese will not be mentioned for the participants. Participants will be asked to consume this breakfast within 15 minutes and the exact meal duration (in minutes) will be noted after completing the meal in order to examine the eating rate. VAS will be used to measure subjective appetite sensations during the post-meal period as well as the pleasantness of the meal and the study products after completing the meal. VAS will be used to measure subjective appetite sensations for the following hours. Three hours following serving of the breakfast meal, participants will be provided with a homogeneous single item ad libitum lunch meal. The meal is a homogeneous dish of spaghetti bolognese providing a total of 8 MJ and the participants are instructed to eat until they are comfortably full. The energy composition of the meal is 15 E% protein, 30 E% fat and 55 E% carbohydrate. VAS will be used to measure subjective appetite sensations during the post-meal period as well as the pleasantness of the meal after completing the meal. The meal duration (in minutes) will be noted after completing the meal. The ad libitum meal ends the study day, and the participant will be free to leave afterwards.
- Being tested
- High protein/high fat hard cheese, High protein/low fat hard cheese, Low protein/high fat creme cheese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein/high fat hard cheeseOther
Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.
High protein/low fat hard cheeseOther
Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.
Low protein/high fat creme cheeseOther
Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.
| Study group | Role | What they receive |
|---|---|---|
| High protein/high fat hard cheese | Active comparator | Served for breakfast together with bread, juice and coffee, tea or water Receives: Other: High protein/high fat hard cheese |
| High protein/low fat hard cheese | Active comparator | Served for breakfast together with bread, juice and coffee, tea or water Receives: Other: High protein/low fat hard cheese |
| Low protein/high fat creme cheese | Experimental | Served for breakfast together with bread, juice and coffee, tea or water Receives: Other: Low protein/high fat creme cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total accumulated energy intake (overall intake of kJ from breakfast and ad libitum meal)
The primary outcome of the study is the total accumulated energy intake including the breakfast meal and the ad libitum test meal.
Measured: During the three hour study day
Secondary outcomes (2)
Feelings of appetite
Secondary outcomes of the study are VAS scores for appetite every 30 minutes throughout the study test days where the feelings of appetite will be analysed in relation to energy content of the meals by calculating satiety quotients.
Measured: During the three hour study day
Pleasantness of meals and test products
Furthermore secondary outcomes are the VAS scores for the pleasantness of the meals after completing each meal as well as the pleasantness of the test products.
Measured: After completing each meal at every test day , up to 200 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite; Lack or Loss, Nonorganic OriginStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Fromageries Bel SA
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, Professor, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582723
- Sponsor's protocol ID
- B323
- Acronym
- STABLE
- Status last verified
- Feb 2016
- First submitted
- 17 Sep 2015
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Cheeses With Different Energy Content on Appetite
- ClinicalTrials.gov ID
- NCT02582723
- Acronym / sponsor ID
- STABLE / B323
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Fromageries Bel SA
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Oct 2015 (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.
A double-blind, randomised crossover design will be employed with three experimental conditions; High protein/high fat hard cheese, high protein/low fat hard cheese, and low protein/high fat creme cheese served at least 7 days apart. After having successfully completed screening procedures, eligible participants will be invited for three separate test days. The test days should be performed at least 7 days apart; however for logistical reasons 4 days can be accepted. On the test days, the products will be provided in a randomized order, and subjective appetite ratings will be measured every 30 minutes for the following 3 hours. Subsequent energy intake will be measured by an ad libitum meal 3 hours following serving of the breakfast meal.
Detailed description
Participants will arrive at the laboratory after an overnight fast (at least from 10:00 pm) with the use of the least strenuously transportation possible (no bicycling or long distance walk). In addition, the preceding two days (48h) before each of the study days; no intensive physical activity or consumption of alcohol is allowed in order to obtain standardization of the participants.
Once settled into an individual feeding cubicle, visual analogue scales (VAS) will be completed for the measurement of fasting appetite levels. A standardized fixed breakfast meal (providing approximately 20% of total estimated energy need) consisting of 80 g. cheese with bread, orange juice and a cup (125 mL) of coffee/the/water (milk is not allowed). The amounts of bread (70.5 g.) and juice (132 g.) are calculated with Babybel original as reference, and these amounts for bread and juice are kept constant regardless of the cheese provided. The cheese will be served blinded together with the bread, and the brand of cheese will not be mentioned for the participants. Participants will be asked to consume this breakfast within 15 minutes and the exact meal duration (in minutes) will be noted after completing the meal in order to examine the eating rate. VAS will be used to measure subjective appetite sensations during the post-meal period as well as the pleasantness of the meal and the study products after completing the meal. VAS will be used to measure subjective appetite sensations for the following hours. Three hours following serving of the breakfast meal, participants will be provided with a homogeneous single item ad libitum lunch meal. The meal is a homogeneous dish of spaghetti bolognese providing a total of 8 MJ and the participants are instructed to eat until they are comfortably full. The energy composition of the meal is 15 E% protein, 30 E% fat and 55 E% carbohydrate. VAS will be used to measure subjective appetite sensations during the post-meal period as well as the pleasantness of the meal after completing the meal. The meal duration (in minutes) will be noted after completing the meal. The ad libitum meal ends the study day, and the participant will be free to leave afterwards.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High protein/high fat hard cheese | Active comparator | Other: High protein/high fat hard cheeseServed for breakfast together with bread, juice and coffee, tea or water |
| High protein/low fat hard cheese | Active comparator | Other: High protein/low fat hard cheeseServed for breakfast together with bread, juice and coffee, tea or water |
| Low protein/high fat creme cheese | Experimental | Other: Low protein/high fat creme cheeseServed for breakfast together with bread, juice and coffee, tea or water |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants who have provided written informed consent
- Healthy men and women
- Ages between 18 and 60 years
- BMI between 20.0-31.9 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
Key exclusion criteria (13 listed)
- Participants not able to comply with the study protocol, including consumption of the specific study foods
- Significant health problems as judged by the investigator
- Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator
- Pregnant, planning to become pregnant within the next 4 weeks or breastfeeding (women only)
- History of anaphylaxis to food
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 |
|---|---|---|
| High protein/high fat hard cheeseAssess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content. | Other | High protein/high fat hard cheese |
| High protein/low fat hard cheeseAssess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content. | Other | High protein/low fat hard cheese |
| Low protein/high fat creme cheeseAssess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content. | Other | Low protein/high fat creme cheese |
Primary outcome
Total accumulated energy intake (overall intake of kJ from breakfast and ad libitum meal)
Time frame: During the three hour study day
The primary outcome of the study is the total accumulated energy intake including the breakfast meal and the ad libitum test meal.
2 secondary outcomes
Feelings of appetite
Time frame: During the three hour study day
Pleasantness of meals and test products
Time frame: After completing each meal at every test day , up to 200 minutes
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 18 Feb 2016.
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, Professor study chair
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein/high fat hard cheese, High protein/low fat hard cheese and Low protein/high fat creme cheese in people with Appetite; Lack or Loss, Nonorganic Origin, 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 6 inclusion and 13 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 18 Feb 2016. 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?
Total accumulated energy intake (overall intake of kJ from breakfast and ad libitum meal) (time frame: During the three hour study day). 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 18 Feb 2016.