Appetitive BehaviorNCT04922125
Food Structure of Pulses and Satiety
A study testing Pulse flour and Pre-processed pulse flour in people with Appetitive Behavior, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Diets containing (whole) pulses have been associated with the potential to increase satiety (and acute food intake). In vitro digestion studies of pulses have shown that (thermal) processing has the potential to modulate macronutrient digestion kinetics. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Pulse flour and Pre-processed pulse flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2021to 31 Jul 2021
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI (between 18 and 30 kg/m2)
- Healthy men
- Age between 18-45
- Regular breakfast eaters (≥ 4 times a week)
- No allergies
Who cannot join
- Chronic diseases (diabetes, cardiovascular diseases, or other metabolic diseases that could affect the study)
- Use of daily prescription medicine
- Use of dietary supplements that could affect appetite (used within the last month up to or during the study)
- Smoking or use of any nicotine product (used daily within the last three months up to or during the study)
- Over 10 h of strenuous physical activity per week
- Participation in other clinical studies (participation within the last month up to the study or during the study)
Show all 9Show fewer
- Food allergies
- Weight change of more than ±3 kg from screening until the trial will be completed
- Inability to comply with the procedures required by the study (including an 8-10 h fast before the trial days).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Food Science/ Section for Food Design and Consumer Behaviour
Copenhagen
About this study
Official title: Impact of Pulse Processing on Feelings of Appetite and Satiety
Diets containing (whole) pulses have been associated with the potential to increase satiety (and acute food intake). In vitro digestion studies of pulses have shown that (thermal) processing has the potential to modulate macronutrient digestion kinetics. Changes in food (micro)strucutral properties have been identified to retard nutrient release, with a possible effect on appetite sensations. Based on distinct in vitro digestion behaviour, two differently processed pulse meals were chosen to be investigated in humans with the aim to confirm in vitro findings and gain a mechanistic understanding of the influence of structural aspects of pulses on appetite sensations.
- Conditions
- Appetitive Behavior
- Being tested
- Pulse flour, Pre-processed pulse flour
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse flourCombination product
Traditionally processed pulse flour in vitro digestion conditions were related to potentially influence appetite sensations.
Pre-processed pulse flourCombination product
Pre-processing of pulse flour was related to altered in vitro digestion conditions and thus suggested to potentially influence appetite sensations.
| Study group | Role | What they receive |
|---|---|---|
| Pulse flour | Experimental | Puree produced from pulse flours and with added oil and herbs/spices. To standardize test products on textural aspects, different levels of thickener will be added. All test products will be produced in the Future Consumer Lab at the Department of Food Science at the University of Copenhagen prior to the appetite test days. Pulse flour will be produced in the food-grade laboratory environment at the Department of Food Design and Consumer behavior and dried prior to use. Receives: Combination Product: Pulse flour |
| Pre-processed pulse flour | Experimental | Puree produced from pre-processed pulse flour with different structural aspects and with added oil and herbs/spices. To standardize test products on textural aspects, different levels of thickener will be added. All test products will be produced in the Future Consumer Lab at the Department of Food Science at the University of Copenhagen prior to the appetite test days. Pulse flour will be produced in the food-grade laboratory environment at the Department of Food Design and Consumer behavior and dried prior to use. Receives: Combination Product: Pre-processed pulse flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported appetite assessment throughout the appetite test days
Visual analogue scales (VAS) will be measuring differences in perception of satiety, fullness, hunger and predicted prospective food consumption between the experimental condition compared to the control condition, with VAS 0-100 mm with 0 indicating no hunger or perceived ability to consume food / no satiety or no fullness)
Measured: 2.5 hours
Secondary outcomes (2)
Secondary Energy Intake (kJ) of ad libitum meal
Differences in (secondary) energy intake after the test-meals at the ad libitum meal will be compared to the control condition
Measured: 30 min
Satiety quotient (SQ)
Visual analogue scales (VAS) will be measuring differences in SQ consumption before and after the experimental condition compared to the control condition (0-100 mm with 0 indicating no hunger or perccieved ability to consume food / no satiety or no fullness)
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies 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
- Model description
- A single-blind, randomised crossover design with one arm.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Katharina Pälchen, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922125
- Sponsor's protocol ID
- UCopenhagen 514-0254/21-5000
- Status last verified
- Aug 2021
- First submitted
- 4 Jun 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pulse Processing on Feelings of Appetite and Satiety
- ClinicalTrials.gov ID
- NCT04922125
- Acronym / sponsor ID
- UCopenhagen 514-0254/21-5000
- Conditions
- Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- 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.
Diets containing (whole) pulses have been associated with the potential to increase satiety (and acute food intake). In vitro digestion studies of pulses have shown that (thermal) processing has the potential to modulate macronutrient digestion kinetics. Changes in food (micro)strucutral properties have been identified to retard nutrient release, with a possible effect on appetite sensations. Based on distinct in vitro digestion behaviour, two differently processed pulse meals were chosen to be investigated in humans with the aim to confirm in vitro findings and gain a mechanistic understanding of the influence of structural aspects of pulses on appetite sensations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-blind, randomised crossover design with one arm.
| Arm | Type | Receives |
|---|---|---|
| Pulse flour | Experimental | Combination Product: Pulse flourPuree produced from pulse flours and with added oil and herbs/spices. To standardize test products on textural aspects, different levels of thickener will be added. All test products will be produced in the Future Consumer Lab at the Department of Food Science at the University of Copenhagen prior to the appetite test days. Pulse flour will be produced in the food-grade laboratory environment at the Department of Food Design and Consumer behavior and dried prior to use. |
| Pre-processed pulse flour | Experimental | Combination Product: Pre-processed pulse flourPuree produced from pre-processed pulse flour with different structural aspects and with added oil and herbs/spices. To standardize test products on textural aspects, different levels of thickener will be added. All test products will be produced in the Future Consumer Lab at the Department of Food Science at the University of Copenhagen prior to the appetite test days. Pulse flour will be produced in the food-grade laboratory environment at the Department of Food Design and Consumer behavior and dried prior to use. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI (between 18 and 30 kg/m2)
- Healthy men
- Age between 18-45
- Regular breakfast eaters (≥ 4 times a week)
- No allergies
Key exclusion criteria (9 listed)
- Chronic diseases (diabetes, cardiovascular diseases, or other metabolic diseases that could affect the study)
- Use of daily prescription medicine
- Use of dietary supplements that could affect appetite (used within the last month up to or during the study)
- Smoking or use of any nicotine product (used daily within the last three months up to or during the study)
- Over 10 h of strenuous physical activity per week
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 |
|---|---|---|
| Pulse flourTraditionally processed pulse flour in vitro digestion conditions were related to potentially influence appetite sensations. | Combination product | Pulse flour |
| Pre-processed pulse flourPre-processing of pulse flour was related to altered in vitro digestion conditions and thus suggested to potentially influence appetite sensations. | Combination product | Pre-processed pulse flour |
Primary outcome
Self-reported appetite assessment throughout the appetite test days
Time frame: 2.5 hours
Visual analogue scales (VAS) will be measuring differences in perception of satiety, fullness, hunger and predicted prospective food consumption between the experimental condition compared to the control condition, with VAS 0-100 mm with 0 indicating no hunger or perceived ability to consume food / no satiety or no fullness)
2 secondary outcomes
Secondary Energy Intake (kJ) of ad libitum meal
Time frame: 30 min
Satiety quotient (SQ)
Time frame: 30 min
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 27 Aug 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse flour and Pre-processed pulse flour in people with Appetitive Behavior, 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 5 inclusion and 9 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 27 Aug 2021. 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?
Self-reported appetite assessment throughout the appetite test days (time frame: 2.5 hours). 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 27 Aug 2021.