Glucose, High BloodNCT05182190
Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults
A study testing White bread, Black beans whole boiled and Knife Mill pasta in people with Glucose, High Blood, run by Iowa State University at 1 site in United States.
Trial summary
The study purpose is to determine the effect of eating three (3) different pasta flour formulations made from 100% black beans (Zenith) in a meal matrix (spaghetti sauce) on postprandial glycemic response in healthy adults. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose, High Blood
- What is being tested?
- White bread, Black beans whole boiled and Knife Mill pasta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2019to 15 Mar 2020
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal blood glucose
- BMI between 20-29.9 kg/m2.
- Chronic health conditions, e.g., hypertension, gastrointestinal disease.
Who cannot join
- Weight changes of >10% of body weight within previous 6 months
- Pregnant or breastfeeding
- Allergy to peas, beans, lentils, tomatoes, gluten, or latex
- Unwillingness or inability to follow study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Iowa State University, Food Science and Human Nutrition Department
Ames, Iowa, 50011
About this study
The study purpose is to determine the effect of eating three (3) different pasta flour formulations made from 100% black beans (Zenith) in a meal matrix (spaghetti sauce) on postprandial glycemic response in healthy adults.
Read the detailed description
The 5 test treatments (white bread (negative control), whole black beans (positive control), and 3 different pasta formulations) will be administered randomly over five weeks. Meals will be combined with spaghetti sauce for a total available carbohydrate amount of 50g.
Venous blood samples will be collected for glucose and insulin analysis at time 0 (fasting) and at 30, 60, 90, 120, and 180 minutes post-treatment (timing of the post-treatment blood draws started at time 0 [post-treatment], which is when the participant starts consuming the treatment meal). Blood analysis was completed by a reputable biomarker diagnostics laboratory, Quest Diagnostics.
Anthropometric measures such as weight, height, waist circumference, and blood pressure were collected at screening and at the start of each test day. Thirteen hours before testing, participants consumed a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes. This control meal was selected by each participant before the start of the study. Each participant was provided the same frozen meal every time, since the subjects serve as their own controls. The day before test day, participants completed a 24 hour food recall, satiety, and gastrointestinal questionnaires. The morning of each test day participants completed the International Physical Activity Questionnaire (IPAQ), satiety, and gastrointestinal questionnaires.
- Conditions
- Glucose, High Blood
- Being tested
- White bread, Black beans whole boiled, Knife Mill pasta, Combo Flour Pasta, Cyclone Flour Pasta
- Keywords
- glucose, insulin, legumes
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White breadDietary supplement
Toasted white bread
Black beans whole boiledDietary supplement
Whole boiled black beans with spaghetti sauce
Knife Mill pastaDietary supplement
Black bean pasta (KM) with spaghetti sauce
Combo Flour PastaDietary supplement
Black bean pasta (Combo) with spaghetti sauce (medium protein flour)
Cyclone Flour PastaDietary supplement
Black bean pasta (Cyclone) with spaghetti sauce (low protein flour)
| Study group | Role | What they receive |
|---|---|---|
| Control - White bread | Active comparator | Commercial white bread in a 50 gram available carbohydrate dose Receives: Dietary Supplement: White bread |
| Control - whole black beans | Active comparator | Whole boiled black beans (Zenith) in a 50 gram available carbohydrate dose Receives: Dietary Supplement: Black beans whole boiled |
| Knife Mill pasta | Experimental | Heat treated black bean flour made with standard Knife Mill techniques Receives: Dietary Supplement: Knife Mill pasta |
| Combined pasta | Experimental | Black bean flour with medium protein made with novel compression/decompression mill Receives: Dietary Supplement: Combo Flour Pasta |
| Cyclone pasta | Experimental | Black bean flour with lower protein made with novel compression/decompression mill Receives: Dietary Supplement: Cyclone Flour Pasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline blood glucose over 3 hours (glycemic response)
Venous blood samples were collected via venous catheter. Whole blood samples were analyzed for glucose content and insulin at commercial laboratory.
Measured: Time 0 (fasting) then every 30 minutes for 3 hours
Secondary outcomes (1)
Change in satiety sensation
Satiety level measured using a visual analog scale (0-100) every 30 minutes postprandially. A higher score indicates greater satiety.
Measured: Time 0 (fasting) then every 30 minutes for 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start10 Jul 2019
- Primary completion29 Feb 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose, High BloodStudies of the same condition, open and under way.
- 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
- Model description
- 5 x 5 crossover study with 3 treatments and two controls
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Principal investigator, Donna Winham, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182190
- Sponsor's protocol ID
- 17-191BB
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults
- ClinicalTrials.gov ID
- NCT05182190
- Acronym / sponsor ID
- 17-191BB
- Conditions
- Glucose, High Blood
- Keywords
- glucose, insulin, legumes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 10 Jan 2022 (actual)
- 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 study purpose is to determine the effect of eating three (3) different pasta flour formulations made from 100% black beans (Zenith) in a meal matrix (spaghetti sauce) on postprandial glycemic response in healthy adults.
Detailed description
The 5 test treatments (white bread (negative control), whole black beans (positive control), and 3 different pasta formulations) will be administered randomly over five weeks. Meals will be combined with spaghetti sauce for a total available carbohydrate amount of 50g.
Venous blood samples will be collected for glucose and insulin analysis at time 0 (fasting) and at 30, 60, 90, 120, and 180 minutes post-treatment (timing of the post-treatment blood draws started at time 0 [post-treatment], which is when the participant starts consuming the treatment meal). Blood analysis was completed by a reputable biomarker diagnostics laboratory, Quest Diagnostics.
Anthropometric measures such as weight, height, waist circumference, and blood pressure were collected at screening and at the start of each test day. Thirteen hours before testing, participants consumed a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes. This control meal was selected by each participant before the start of the study. Each participant was provided the same frozen meal every time, since the subjects serve as their own controls. The day before test day, participants completed a 24 hour food recall, satiety, and gastrointestinal questionnaires. The morning of each test day participants completed the International Physical Activity Questionnaire (IPAQ), satiety, and gastrointestinal questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 5 x 5 crossover study with 3 treatments and two controls
| Arm | Type | Receives |
|---|---|---|
| Control - White bread | Active comparator | Dietary Supplement: White breadCommercial white bread in a 50 gram available carbohydrate dose |
| Control - whole black beans | Active comparator | Dietary Supplement: Black beans whole boiledWhole boiled black beans (Zenith) in a 50 gram available carbohydrate dose |
| Knife Mill pasta | Experimental | Dietary Supplement: Knife Mill pastaHeat treated black bean flour made with standard Knife Mill techniques |
| Combined pasta | Experimental | Dietary Supplement: Combo Flour PastaBlack bean flour with medium protein made with novel compression/decompression mill |
| Cyclone pasta | Experimental | Dietary Supplement: Cyclone Flour PastaBlack bean flour with lower protein made with novel compression/decompression mill |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- normal blood glucose
- BMI between 20-29.9 kg/m2.
- Chronic health conditions, e.g., hypertension, gastrointestinal disease.
Key exclusion criteria (4 listed)
- Weight changes of >10% of body weight within previous 6 months
- Pregnant or breastfeeding
- Allergy to peas, beans, lentils, tomatoes, gluten, or latex
- Unwillingness or inability to follow study protocol
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 |
|---|---|---|
| White breadToasted white bread | Dietary supplement | Control - White bread |
| Black beans whole boiledWhole boiled black beans with spaghetti sauce | Dietary supplement | Control - whole black beans |
| Knife Mill pastaBlack bean pasta (KM) with spaghetti sauce | Dietary supplement | Knife Mill pasta |
| Combo Flour PastaBlack bean pasta (Combo) with spaghetti sauce (medium protein flour) | Dietary supplement | Combined pasta |
| Cyclone Flour PastaBlack bean pasta (Cyclone) with spaghetti sauce (low protein flour) | Dietary supplement | Cyclone pasta |
Primary outcome
Change in baseline blood glucose over 3 hours (glycemic response)
Time frame: Time 0 (fasting) then every 30 minutes for 3 hours
Venous blood samples were collected via venous catheter. Whole blood samples were analyzed for glucose content and insulin at commercial laboratory.
1 secondary outcome
Change in satiety sensation
Time frame: Time 0 (fasting) then every 30 minutes for 3 hours
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 10 Jan 2022.
- Individual participant dataSharing planned: No
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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.
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 White bread, Black beans whole boiled and Knife Mill pasta in people with Glucose, High Blood, run by Iowa State University at 1 site in United States.
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 3 inclusion and 4 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 10 Jan 2022. 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 United States. 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?
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?
Change in baseline blood glucose over 3 hours (glycemic response) (time frame: Time 0 (fasting) then every 30 minutes for 3 hours). 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 10 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.