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OpenTrials
Completed

NCT Number: NCT04922125

Food Structure of Pulses 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.

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Key information

Conditions

Appetitive Behavior Behavior Behavior, Animal

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food Science/ Section for Food Design and Consumer Behaviour

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pulse flour

Combination Product

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

Pre-processed pulse flour

Combination Product

Pre-processing of pulse flour was related to altered in vitro digestion conditions and thus suggested to potentially influence appetite sensations.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Secondary Energy Intake (kJ) of ad libitum meal

    Time frame: 30 min

    Differences in (secondary) energy intake after the test-meals at the ad libitum meal will be compared to the control condition

  2. Satiety quotient (SQ)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • KU Leuven

Registry information

Official study title

Impact of Pulse Processing on Feelings of Appetite and Satiety

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2021
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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