NCT04378374

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

May 2, 2020

Last Update Submit

March 14, 2023

Conditions

Keywords

PulsesFlourFood IntakeSatietyBlood Glucose

Outcome Measures

Primary Outcomes (3)

  • Blood Glucose

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

    0-120 minutes

  • Food Intake

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

    120 minutes

  • Subjective Appetite

    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).

    0-120 minutes

Secondary Outcomes (2)

  • Physical Comfort

    0-120 minutes

  • Palatability of Food

    5 minutes

Study Arms (4)

Baked food made of lentil flour

EXPERIMENTAL

Food prepared with 100% lentil flour

Other: Food-1

Baked food made of lentil flour and wheat flour

EXPERIMENTAL

Food prepared with a mixture of lentil flour and wheat flour

Other: Food-2

Baked food made of wheat flour

EXPERIMENTAL

Food prepared with 100% wheat flour

Other: Food-3

Water

EXPERIMENTAL

Potable water (energy and carbohydrate-free control)

Other: Food-4

Interventions

Food-1OTHER

Baked food made of lentil flour

Baked food made of lentil flour
Food-2OTHER

Baked food made of lentil flour and wheat flour

Baked food made of lentil flour and wheat flour
Food-3OTHER

Baked food made of wheat flour

Baked food made of wheat flour
Food-4OTHER

Potable water (energy and carbohydrate-free control)

Water

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Location

Study Officials

  • Bohdan Luhovyy, PhD

    Mount Saint Vincent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The participants and investigators are blinded and could not distinguish the food formulated with different flours. The taste and flavour in all treatments were similar due to added flavourings.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 7, 2020

Study Start

September 16, 2019

Primary Completion

August 31, 2022

Study Completion

December 31, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations