- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02666586
Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control
January 19, 2023 updated by: University of Manitoba
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).
Study Overview
Status
Completed
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3T 2N2
- Richardson Centre for Functional Foods and Nutraceuticals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control smoothie
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
|
Breakfast smoothie with 32 g whole faba bean powder (300g).
Breakfast smoothie with 32 g faba bean protein concentrate.
Breakfast smoothie with 33 g faba bean starch.
Breakfast smoothie with 32 g faba bean protein isolate.
|
Experimental: Faba Bean powder smoothie
Breakfast smoothie with 32 g whole faba bean powder.
|
Breakfast smoothie with 32 g faba bean protein concentrate.
Breakfast smoothie with 33 g faba bean starch.
Breakfast smoothie with 32 g faba bean protein isolate.
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
|
Experimental: Faba bean protein concentrate smoothie
Breakfast smoothie with 32 g faba bean protein concentrate.
|
Breakfast smoothie with 32 g whole faba bean powder (300g).
Breakfast smoothie with 33 g faba bean starch.
Breakfast smoothie with 32 g faba bean protein isolate.
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
|
Experimental: Faba bean starch smoothie
Breakfast smoothie with 33 g faba bean starch.
|
Breakfast smoothie with 32 g whole faba bean powder (300g).
Breakfast smoothie with 32 g faba bean protein concentrate.
Breakfast smoothie with 32 g faba bean protein isolate.
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
|
Experimental: Faba bean protein isolate smoothie
Breakfast smoothie with 32 g faba bean protein isolate.
|
Breakfast smoothie with 32 g whole faba bean powder (300g).
Breakfast smoothie with 32 g faba bean protein concentrate.
Breakfast smoothie with 33 g faba bean starch.
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood glucose
Time Frame: 0-200 minutes
|
measured by finger prick blood samples by glucose meters
|
0-200 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
appetite
Time Frame: 0-200 minutes
|
measured by VAS questionnaire
|
0-200 minutes
|
satiety hormones
Time Frame: 0- 200mins
|
measured by enzyme-linked immunosorbent assay (ELISA)
|
0- 200mins
|
insulin
Time Frame: 0-200mins
|
measured by ELISA
|
0-200mins
|
food intake
Time Frame: 120 minutes following consumption of the faba bean smoothie
|
energy intake at ad-libitum pizza meal
|
120 minutes following consumption of the faba bean smoothie
|
physical comfort
Time Frame: 0-200 minutes
|
measured by VAS questionnaire
|
0-200 minutes
|
energy/fatigue
Time Frame: 0-200 minutes
|
measured by VAS questionaire
|
0-200 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
October 21, 2017
Study Completion (Actual)
October 21, 2017
Study Registration Dates
First Submitted
November 19, 2015
First Submitted That Met QC Criteria
January 25, 2016
First Posted (Estimate)
January 28, 2016
Study Record Updates
Last Update Posted (Actual)
January 23, 2023
Last Update Submitted That Met QC Criteria
January 19, 2023
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- B2015:110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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