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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02666586
Other study ID # B2015:110
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date October 21, 2017

Study information

Verified date April 2021
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

The overall objective is to describe the effect and mechanisms of action of 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). The specific objectives are to test the acute effects of different faba bean ingredient smoothie on: 1) post-prandial blood glucose, appetite, satiety hormone and insulin for 200 minutes, and 2) food intake 120 minutes following consumption of the faba bean smoothie. Two short-term acute studies will be conducted to meet these objectives. Both acute studies will follow a randomized, double blinded, balanced, repeated measures design and the same protocol; except one will have an ad libitum pizza meal (study 1), while the other will have a fixed pizza meal (study 2) at 120 minutes. Half the participants will have blood drawn by IV and the other half will be finger prick.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 21, 2017
Est. primary completion date October 21, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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

Study Design


Intervention

Other:
Faba bean powder smoothie
Breakfast smoothie with 32 g whole faba bean powder (300g).
Faba bean protein concentrate smoothie
Breakfast smoothie with 32 g faba bean protein concentrate.
Faba bean starch smoothie
Breakfast smoothie with 33 g faba bean starch.
Faba bean protein isolate smoothie
Breakfast smoothie with 32 g faba bean protein isolate.
Non-pulse smoothie smoothie
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.

Locations

Country Name City State
Canada Richardson Centre for Functional Foods and Nutraceuticals Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary blood glucose measured by finger prick blood samples by glucose meters 0-200 minutes
Secondary appetite measured by VAS questionnaire 0-200 minutes
Secondary satiety hormones measured by enzyme-linked immunosorbent assay (ELISA) 0- 200mins
Secondary insulin measured by ELISA 0-200mins
Secondary food intake energy intake at ad-libitum pizza meal 120 minutes following consumption of the faba bean smoothie
Secondary physical comfort measured by VAS questionnaire 0-200 minutes
Secondary energy/fatigue measured by VAS questionaire 0-200 minutes
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