Faba BeanNCT02666586
Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control
A study testing Faba bean powder smoothie, Faba bean protein concentrate smoothie and Faba bean starch smoothie in people with Faba Bean and Post-prandial Blood Glucose, run by University of Manitoba at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Faba Bean, Post-prandial Blood Glucose, Appetite
- What is being tested?
- Faba bean powder smoothie, Faba bean protein concentrate smoothie and Faba bean starch smoothie
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to 21 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
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).
Read the 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.
- Conditions
- Faba Bean, Post-prandial Blood Glucose, Appetite, Satiety Hormones, Insulin
- Being tested
- Faba bean powder smoothie, Faba bean protein concentrate smoothie, Faba bean starch smoothie, Faba bean protein isolate smoothie, Non-pulse smoothie smoothie
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faba bean powder smoothieOther
Breakfast smoothie with 32 g whole faba bean powder (300g).
Faba bean protein concentrate smoothieOther
Breakfast smoothie with 32 g faba bean protein concentrate.
Faba bean starch smoothieOther
Breakfast smoothie with 33 g faba bean starch.
Faba bean protein isolate smoothieOther
Breakfast smoothie with 32 g faba bean protein isolate.
Non-pulse smoothie smoothieOther
Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
| Study group | Role | What they receive |
|---|---|---|
| Control smoothie | Placebo comparator | Control smoothie with 32 g corn maltodextrin without added faba bean fractions. Receives: Other: Faba bean powder smoothie; Other: Faba bean protein concentrate smoothie; Other: Faba bean starch smoothie; Other: Faba bean protein isolate smoothie |
| Faba Bean powder smoothie | Experimental | Breakfast smoothie with 32 g whole faba bean powder. Receives: Other: Faba bean protein concentrate smoothie; Other: Faba bean starch smoothie; Other: Faba bean protein isolate smoothie; Other: Non-pulse smoothie smoothie |
| Faba bean protein concentrate smoothie | Experimental | Breakfast smoothie with 32 g faba bean protein concentrate. Receives: Other: Faba bean powder smoothie; Other: Faba bean starch smoothie; Other: Faba bean protein isolate smoothie; Other: Non-pulse smoothie smoothie |
| Faba bean starch smoothie | Experimental | Breakfast smoothie with 33 g faba bean starch. Receives: Other: Faba bean powder smoothie; Other: Faba bean protein concentrate smoothie; Other: Faba bean protein isolate smoothie; Other: Non-pulse smoothie smoothie |
| Faba bean protein isolate smoothie | Experimental | Breakfast smoothie with 32 g faba bean protein isolate. Receives: Other: Faba bean powder smoothie; Other: Faba bean protein concentrate smoothie; Other: Faba bean starch smoothie; Other: Non-pulse smoothie smoothie |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
measured by finger prick blood samples by glucose meters
Measured: 0-200 minutes
Secondary outcomes (6)
appetite
measured by VAS questionnaire
Measured: 0-200 minutes
satiety hormones
measured by enzyme-linked immunosorbent assay (ELISA)
Measured: 0- 200mins
insulin
measured by ELISA
Measured: 0-200mins
food intake
energy intake at ad-libitum pizza meal
Measured: 120 minutes following consumption of the faba bean smoothie
physical comfort
measured by VAS questionnaire
Measured: 0-200 minutes
energy/fatigue
measured by VAS questionaire
Measured: 0-200 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion21 Oct 2017
- Study completion21 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faba BeanStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666586
- Sponsor's protocol ID
- B2015:110
- Status last verified
- Apr 2021
- First submitted
- 19 Nov 2015
- Last updated
- 23 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control
- ClinicalTrials.gov ID
- NCT02666586
- Acronym / sponsor ID
- B2015:110
- Conditions
- Faba Bean, Post-prandial Blood Glucose, Appetite, Satiety Hormones, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 21 Oct 2017 (actual)
- Study completion
- 21 Oct 2017 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control smoothie | Placebo comparator | Other: Faba bean powder smoothie, Other: Faba bean protein concentrate smoothie, Other: Faba bean starch smoothie, Other: Faba bean protein isolate smoothieControl smoothie with 32 g corn maltodextrin without added faba bean fractions. |
| Faba Bean powder smoothie | Experimental | Other: Faba bean protein concentrate smoothie, Other: Faba bean starch smoothie, Other: Faba bean protein isolate smoothie, Other: Non-pulse smoothie smoothieBreakfast smoothie with 32 g whole faba bean powder. |
| Faba bean protein concentrate smoothie | Experimental | Other: Faba bean powder smoothie, Other: Faba bean starch smoothie, Other: Faba bean protein isolate smoothie, Other: Non-pulse smoothie smoothieBreakfast smoothie with 32 g faba bean protein concentrate. |
| Faba bean starch smoothie | Experimental | Other: Faba bean powder smoothie, Other: Faba bean protein concentrate smoothie, Other: Faba bean protein isolate smoothie, Other: Non-pulse smoothie smoothieBreakfast smoothie with 33 g faba bean starch. |
| Faba bean protein isolate smoothie | Experimental | Other: Faba bean powder smoothie, Other: Faba bean protein concentrate smoothie, Other: Faba bean starch smoothie, Other: Non-pulse smoothie smoothieBreakfast smoothie with 32 g faba bean protein isolate. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faba bean powder smoothieBreakfast smoothie with 32 g whole faba bean powder (300g). | Other | Control smoothie, Faba bean protein concentrate smoothie, Faba bean protein isolate smoothie, Faba bean starch smoothie |
| Faba bean protein concentrate smoothieBreakfast smoothie with 32 g faba bean protein concentrate. | Other | Control smoothie, Faba Bean powder smoothie, Faba bean protein isolate smoothie, Faba bean starch smoothie |
| Faba bean starch smoothieBreakfast smoothie with 33 g faba bean starch. | Other | Control smoothie, Faba Bean powder smoothie, Faba bean protein concentrate smoothie, Faba bean protein isolate smoothie |
| Faba bean protein isolate smoothieBreakfast smoothie with 32 g faba bean protein isolate. | Other | Control smoothie, Faba Bean powder smoothie, Faba bean protein concentrate smoothie, Faba bean starch smoothie |
| Non-pulse smoothie smoothieControl smoothie with 32 g corn maltodextrin without added faba bean fractions. | Other | Faba Bean powder smoothie, Faba bean protein concentrate smoothie, Faba bean protein isolate smoothie, Faba bean starch smoothie |
Primary outcome
blood glucose
Time frame: 0-200 minutes
measured by finger prick blood samples by glucose meters
6 secondary outcomes
appetite
Time frame: 0-200 minutes
satiety hormones
Time frame: 0- 200mins
insulin
Time frame: 0-200mins
food intake
Time frame: 120 minutes following consumption of the faba bean smoothie
physical comfort
Time frame: 0-200 minutes
energy/fatigue
Time frame: 0-200 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
Related trials for Faba Bean
Enrolling by invitation
Vicia Faba Peptides and Resistance Training in the Elderly
Healthy Aging
Recruiting
The Effects of MediDrink Platinum+ and Fava Bean Protein Hydrolysate on Fitness in an Aged Population
Sarcopenia in Elderly, Malnourished
Recruiting
Protein Quality of Fava Bean and Honey Chlorella in Humans
Protein Quality of Chlorella and Fababean Meat Analogue
Recruiting
The Effect of Vicia Faba Hydrolysate Supplementation on Muscle Strength Recovery
Muscle Damage, Muscle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faba bean powder smoothie, Faba bean protein concentrate smoothie and Faba bean starch smoothie in people with Faba Bean and Post-prandial Blood Glucose, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose (time frame: 0-200 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.