ObesityNCT02658591
Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control
A study testing Crackers/pasta with added faba bean protein concentrate, Crackers/pasta with added faba bean protein isolate and Crackers/pasta with added faba bean starch in people with Obesity and Diabetes, run by University of Toronto at 1 site in Canada.
Trial summary
The investigators hypothesized that consuming crackers or pasta enriched with faba bean fractions (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean starch), would reduce the blood glucose response to the meal compared to foods without faba bean components and reduce food intake… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- What is being tested?
- Crackers/pasta with added faba bean protein concentrate, Crackers/pasta with added faba bean protein isolate and Crackers/pasta with added faba bean starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to 31 May 2024
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking
- No metabolic disease
- BMI 20 - 25 kg/m^2
- Male
- Age 18-30
Who cannot join
- Intolerance to treatments
- Currently taking appetite-modifying medications
- Restrictive eating
- Smoking
- Over- or underweight
- Breakfast-skipping
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesized that consuming crackers or pasta enriched with faba bean fractions (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean starch), would reduce the blood glucose response to the meal compared to foods without faba bean components and reduce food intake at a meal
- Being tested
- Crackers/pasta with added faba bean protein concentrate, Crackers/pasta with added faba bean protein isolate, Crackers/pasta with added faba bean starch, Crackers/pasta with added faba bean flour, Crackers/pasta with no faba bean fraction
- Keywords
- Food intake, Satiety, Appetite, Glycemia, Faba bean, Protein, Snack
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crackers/pasta with added faba bean protein concentrateDietary supplement
Protein concentrate treatment
Crackers/pasta with added faba bean protein isolateDietary supplement
Protein isolate treatment
Crackers/pasta with added faba bean starchDietary supplement
Starch treatment
Crackers/pasta with added faba bean flourDietary supplement
Flour treatment
Crackers/pasta with no faba bean fractionDietary supplement
Control treatment
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Crackers/pasta with no faba bean fraction Receives: Dietary Supplement: Crackers/pasta with no faba bean fraction |
| Faba bean protein concentrate | Experimental | Crackers/pasta with added faba bean protein concentrate Receives: Dietary Supplement: Crackers/pasta with added faba bean protein concentrate |
| Faba bean protein isolate | Experimental | Crackers/pasta with added faba bean protein isolate Receives: Dietary Supplement: Crackers/pasta with added faba bean protein isolate |
| Faba bean flour | Experimental | Crackers/pasta with added faba bean flour Receives: Dietary Supplement: Crackers/pasta with added faba bean flour |
| Faba bean starch | Experimental | Crackers/pasta with added faba bean starch Receives: Dietary Supplement: Crackers/pasta with added faba bean starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose levels
Each participant will attend 5 sessions in total (randomized 5-arm cross-over design)
Measured: Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 200 minutes (time of completion of each session)
Change in gut hormone levels measured in the blood
Each participant will attend 5 sessions in total (randomized 5-arm cross-over design)
Measured: Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 30 minutes up to 200 minutes (time of completion of each session)
Secondary outcomes (2)
Subjective appetite
Measured using Visual Analog Scales (VAS)
Measured: From 0 to 200 minutes
Ad libitum food (pizza meal) intake as measured by the amount of pizza (in grams) consumed during the 20 minute period
Each participant will also answer questions related to physical comfort, motivation to eat, and rating feelings of energy and fatigue using Visual Analog Scales (VAS)
Measured: 120 minutes after completion of treatment, 20 minutes were allocated to allow for pizza consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- Harvey G Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658591
- Sponsor's protocol ID
- SPG_UofT_FabaBean
- Status last verified
- Jun 2023
- First submitted
- 11 Jan 2016
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan CKY, Fabek H, Mollard RC, Jones PJH, Tulbek MC, Chibbar RN, Gangola MP, Ramadoss BR, Sanchez-Hernandez D, Anderson GH. Faba bean protein flours added to pasta reduce post-ingestion glycaemia, and increase satiety, protein content and quality. Food Funct. 2019 Nov 1;10(11):7476-7488. doi: 10.1039/c9fo01186b. Epub 2019 Oct 31.
PubMed 31670336
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 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
- NCT02658591
- Acronym / sponsor ID
- SPG_UofT_FabaBean
- Keywords
- Food intake, Satiety, Appetite, Glycemia, Faba bean, Protein, Snack
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 20 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.
The investigators hypothesized that consuming crackers or pasta enriched with faba bean fractions (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean starch), would reduce the blood glucose response to the meal compared to foods without faba bean components and reduce food intake at a meal
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Dietary Supplement: Crackers/pasta with no faba bean fractionCrackers/pasta with no faba bean fraction |
| Faba bean protein concentrate | Experimental | Dietary Supplement: Crackers/pasta with added faba bean protein concentrateCrackers/pasta with added faba bean protein concentrate |
| Faba bean protein isolate | Experimental | Dietary Supplement: Crackers/pasta with added faba bean protein isolateCrackers/pasta with added faba bean protein isolate |
| Faba bean flour | Experimental | Dietary Supplement: Crackers/pasta with added faba bean flourCrackers/pasta with added faba bean flour |
| Faba bean starch | Experimental | Dietary Supplement: Crackers/pasta with added faba bean starchCrackers/pasta with added faba bean starch |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoking
- No metabolic disease
- BMI 20 - 25 kg/m^2
- Male
- Age 18-30
Key exclusion criteria (6 listed)
- Intolerance to treatments
- Currently taking appetite-modifying medications
- Restrictive eating
- Smoking
- Over- or underweight
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 |
|---|---|---|
| Crackers/pasta with added faba bean protein concentrateProtein concentrate treatment | Dietary supplement | Faba bean protein concentrate |
| Crackers/pasta with added faba bean protein isolateProtein isolate treatment | Dietary supplement | Faba bean protein isolate |
| Crackers/pasta with added faba bean starchStarch treatment | Dietary supplement | Faba bean starch |
| Crackers/pasta with added faba bean flourFlour treatment | Dietary supplement | Faba bean flour |
| Crackers/pasta with no faba bean fractionControl treatment | Dietary supplement | Control |
Primary outcome
Change in blood glucose levels
Time frame: Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 200 minutes (time of completion of each session)
Each participant will attend 5 sessions in total (randomized 5-arm cross-over design)
Change in gut hormone levels measured in the blood
Time frame: Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 30 minutes up to 200 minutes (time of completion of each session)
Each participant will attend 5 sessions in total (randomized 5-arm cross-over design)
2 secondary outcomes
Subjective appetite
Time frame: From 0 to 200 minutes
Ad libitum food (pizza meal) intake as measured by the amount of pizza (in grams) consumed during the 20 minute period
Time frame: 120 minutes after completion of treatment, 20 minutes were allocated to allow for pizza consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Derived from this study: PubMed 31670336Chan CKY, Fabek H, Mollard RC, Jones PJH, Tulbek MC, Chibbar RN, Gangola MP, Ramadoss BR, Sanchez-Hernandez D, Anderson GH. Faba bean protein flours added to pasta reduce post-ingestion glycaemia, and increase satiety, protein content and quality. Food Funct. 2019 Nov 1;10(11):7476-7488. doi: 10.1039/c9fo01186b. Epub 2019 Oct 31.
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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.
Harvey G Anderson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crackers/pasta with added faba bean protein concentrate, Crackers/pasta with added faba bean protein isolate and Crackers/pasta with added faba bean starch in people with Obesity and Diabetes, run by University of Toronto 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jun 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. 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?
Results are not available in the source record.
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?
Change in blood glucose levels (time frame: Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 200 minutes (time of completion of each session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02658591, which also lists 1 linked publication.
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 26 Jun 2023.