NCT02666586

Brief Summary

To describe the effect and mechanisms of action faba bean powder and fractions (protein, starch and fiber) on glucose and insulin homeostasis, food intake, satiety and metabolic regulation in young adults (18 to 30 years).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration 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

First Submitted

Initial submission to the registry

November 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2017

Completed
Last Updated

January 23, 2023

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

November 19, 2015

Last Update Submit

January 19, 2023

Conditions

Faba BeanPost-prandial Blood GlucoseAppetiteSatiety HormonesInsulin

Outcome Measures

Primary Outcomes (1)

  • blood glucose

    measured by finger prick blood samples by glucose meters

    0-200 minutes

Secondary Outcomes (6)

  • appetite

    0-200 minutes

  • satiety hormones

    0- 200mins

  • insulin

    0-200mins

  • food intake

    120 minutes following consumption of the faba bean smoothie

  • physical comfort

    0-200 minutes

  • +1 more secondary outcomes

Study Arms (5)

Control smoothie

PLACEBO COMPARATOR

Control smoothie with 32 g corn maltodextrin without added faba bean fractions.

Other: Faba bean powder smoothieOther: Faba bean protein concentrate smoothieOther: Faba bean starch smoothieOther: Faba bean protein isolate smoothie

Faba Bean powder smoothie

EXPERIMENTAL

Breakfast smoothie with 32 g whole faba bean powder.

Other: Faba bean protein concentrate smoothieOther: Faba bean starch smoothieOther: Faba bean protein isolate smoothieOther: Non-pulse smoothie smoothie

Faba bean protein concentrate smoothie

EXPERIMENTAL

Breakfast smoothie with 32 g faba bean protein concentrate.

Other: Faba bean powder smoothieOther: Faba bean starch smoothieOther: Faba bean protein isolate smoothieOther: Non-pulse smoothie smoothie

Faba bean starch smoothie

EXPERIMENTAL

Breakfast smoothie with 33 g faba bean starch.

Other: Faba bean powder smoothieOther: Faba bean protein concentrate smoothieOther: Faba bean protein isolate smoothieOther: Non-pulse smoothie smoothie

Faba bean protein isolate smoothie

EXPERIMENTAL

Breakfast smoothie with 32 g faba bean protein isolate.

Other: Faba bean powder smoothieOther: Faba bean protein concentrate smoothieOther: Faba bean starch smoothieOther: Non-pulse smoothie smoothie

Interventions

Faba bean powder smoothieOTHER

Breakfast smoothie with 32 g whole faba bean powder (300g).

Control smoothieFaba bean protein concentrate smoothieFaba bean protein isolate smoothieFaba bean starch smoothie
Faba bean protein concentrate smoothieOTHER

Breakfast smoothie with 32 g faba bean protein concentrate.

Control smoothieFaba Bean powder smoothieFaba bean protein isolate smoothieFaba bean starch smoothie
Faba bean starch smoothieOTHER

Breakfast smoothie with 33 g faba bean starch.

Control smoothieFaba Bean powder smoothieFaba bean protein concentrate smoothieFaba bean protein isolate smoothie
Faba bean protein isolate smoothieOTHER

Breakfast smoothie with 32 g faba bean protein isolate.

Control smoothieFaba Bean powder smoothieFaba bean protein concentrate smoothieFaba bean starch smoothie
Non-pulse smoothie smoothieOTHER

Control smoothie with 32 g corn maltodextrin without added faba bean fractions.

Faba Bean powder smoothieFaba bean protein concentrate smoothieFaba bean protein isolate smoothieFaba bean starch smoothie

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • non-smoking males
  • aged 20-30 years (min/max age)
  • a body mass index between 20 and 25 kg/m2 (the range generally accepted as ideal/healthy by Health and Welfare Canada)

You may not qualify if:

  • individuals diagnosed with diabetes
  • those on medication
  • breakfast skippers
  • on an energy restricted diet
  • this study excludes females because appetite and blood glucose during the female menstruation cycle changes due to fluctuations in hormones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

January 28, 2016

Study Start

January 1, 2016

Primary Completion

October 21, 2017

Study Completion

October 21, 2017

Last Updated

January 23, 2023

Record last verified: 2021-04

Locations

CA(1)