Food Structure of Pulses and Satiety

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT04922125

Collaborator

KU Leuven (Other)

Enrollment

Location

Arms

Actual Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Appetitive Behavior	Combination Product: Pulse flour Combination Product: Pre-processed pulse flour	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

A single-blind, randomised crossover design with one arm.A single-blind, randomised crossover design with one arm.

Masking:

Single (Participant)

Masking Description:

Single-blind

Primary Purpose:

Prevention

Official Title:

Impact of Pulse Processing on Feelings of Appetite and Satiety

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Combination Product: Pulse flour Traditionally processed pulse flour in vitro digestion conditions were related to potentially influence appetite sensations.
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.	Combination Product: 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.

Arm

Intervention/Treatment

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.

Combination Product: Pulse flour

Traditionally processed pulse flour in vitro digestion conditions were related to potentially influence appetite sensations.

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.

Combination Product: 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.

Outcome Measures

Primary Outcome Measures

Self-reported appetite assessment throughout the appetite test days [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)

Secondary Outcome Measures

Secondary Energy Intake (kJ) of ad libitum meal [30 min]
Differences in (secondary) energy intake after the test-meals at the ad libitum meal will be compared to the control condition
Satiety quotient (SQ) [30 min]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Food Science/ Section for Food Design and Consumer Behaviour	Copenhagen		Denmark

Sponsors and Collaborators

University of Copenhagen
KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katharina Pälchen, Principal Investigator, KU Leuven

ClinicalTrials.gov Identifier:

NCT04922125

Other Study ID Numbers:

UCopenhagen 514-0254/21-5000

First Posted:

Jun 10, 2021

Last Update Posted:

Aug 27, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 27, 2021