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Completed

NCT Number: NCT04378374

The Effect of Pulse Flours on Blood Glucose, Satiety and Food Intake

Pulse flours represent a fast-growing segment on the functional food market; however, their health effects are not well understood. The observational studies and acute trials have established the link between frequent consumption of cooked whole pulses (beans, peas, lentils and chickpeas) and healthier body weight and improved blood glucose control. However, it is not clear whether these effects still remain after the processing of pulses into flours. The investigators hypothesized that the baked food products formulated with lentil flour of the same particle size as all-purpose wheat flour may reduce postprandial glycaemia and elicit a stronger suppression of subjective appetite due to its higher content of protein and resistant carbohydrate compared to all-purpose wheat flour. The treatments will be formulated either with lentil flour or with all-purpose wheat flour of similar particle size or with their combination. The objective of the project is to test the effect of foods formulated with lentil flour and/or wheat flour on blood glucose, short-term food intake and subjective appetite.

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Key information

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy young male and female adults (19-35 y) with body mass index (BMI) of 20.0-24.9kg/m2

Exclusion criteria

  • Breakfast skippers
  • Smokers (including e-cigarettes) / cannabis consumers
  • Those with BMI < 18.5 and > 24.5 kg/m2
  • People with chronic diseases
  • People with impaired blood glucose control
  • People taking medication that may affect central and peripheral mechanisms of food intake regulation, blood glucose control, cognitive performance and sedative medication.
  • People with intellectual disabilities (excluded due to their inability to comprehend hedonic and visual analogue scales used in the study).
  • People with food allergies or gastrointestinal disorders (e.g., IBS and others).

Treatment and study plan

Food-1

Other

Baked food made of lentil flour

Food-2

Other

Baked food made of lentil flour and wheat flour

Food-3

Other

Baked food made of wheat flour

Food-4

Other

Potable water (energy and carbohydrate-free control)

Primary outcomes

  1. Blood Glucose

    Time frame: 0-120 minutes

    The concentration of venous blood glucose before and after each treatment consumption

  2. Food Intake

    Time frame: 120 minutes

    The amount of energy (kcal) consumed ad libitum at the test meal (pizza lunch) two hours after each treatment consumption

  3. Subjective Appetite

    Time frame: 0-120 minutes

    The subjective assessment of appetite parameters including desire to eat, fullness, hunger and a prospective food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).

Secondary outcomes

  1. Physical Comfort

    Time frame: 0-120 minutes

    The subjective assessment of wellness and gastrointestinal symptoms including a feeling of nausea, diarrhea, flatulence, and other parameters measured with 100 mm Visual Analogue Scales with two opposite statements at each end.

  2. Palatability of Food

    Time frame: 5 minutes

    The palatability of the treatments will be measured immediately after consumption with a 100 mm Visual Analogue Scale with two opposite statements at each end or with a 9-point hedonic scale.

Sponsors and collaborators

Lead sponsor

Mount Saint Vincent University

Other

Registry information

Official study title

The Effect of Food Formulated With Pulse Flours on Blood Glucose, Satiety and Food Intake

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 7, 2020
Registry last updated
Mar 16, 2023

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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