Food Structure of Pulses and Satiety

Appetitive Behavior Clinical Trial

Official title:

Impact of Pulse Processing on Feelings of Appetite and Satiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922125
• Other study ID #: UCopenhagen 514-0254/21-5000
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Appetitive Behavior

Intervention

Combination Product:
• Pulse flour
Traditionally processed pulse flour in vitro digestion conditions were related to potentially influence appetite sensations.
• Pre-processed pulse flour
Pre-processing of pulse flour was related to altered in vitro digestion conditions and thus suggested to potentially influence appetite sensations.

Locations

Country	Name	City	State
Denmark	Department of Food Science/ Section for Food Design and Consumer Behaviour	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	KU Leuven

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2.5 hours
Secondary	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	30 min
Secondary	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)	30 min