- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922125
Food Structure of Pulses and Satiety
August 23, 2021 updated by: Katharina Pälchen, University of Copenhagen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark
- Department of Food Science/ Section for Food Design and Consumer Behaviour
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- BMI (between 18 and 30 kg/m2)
- Healthy men
- Age between 18-45
- Regular breakfast eaters (≥ 4 times a week)
- No allergies
Exclusion Criteria:
- 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)
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pulse flour
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.
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Traditionally processed pulse flour in vitro digestion conditions were related to potentially influence appetite sensations.
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Experimental: Pre-processed pulse flour
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.
|
Pre-processing of pulse flour was related to altered in vitro digestion conditions and thus suggested to potentially influence appetite sensations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-reported appetite assessment throughout the appetite test days
Time Frame: 2.5 hours
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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)
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2.5 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Secondary Energy Intake (kJ) of ad libitum meal
Time Frame: 30 min
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Differences in (secondary) energy intake after the test-meals at the ad libitum meal will be compared to the control condition
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30 min
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Satiety quotient (SQ)
Time Frame: 30 min
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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)
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30 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
June 4, 2021
First Submitted That Met QC Criteria
June 4, 2021
First Posted (Actual)
June 10, 2021
Study Record Updates
Last Update Posted (Actual)
August 27, 2021
Last Update Submitted That Met QC Criteria
August 23, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- UCopenhagen 514-0254/21-5000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.