Appetite and Glucose ResponsesBFENCT02110511
Body Responses to Bean Physical Form and "Beano"
A study testing blended lentils, whole lentils and no lentils in people with Appetite and Glucose Responses, run by Purdue University at 1 site in United States.
Trial summary
The aim of this study is to determine the effects of bean physical form (whole versus blended) and Beano on postprandial responses. The postprandial responses the investigators will examine include blood glucose, appetite, metabolic rate, physical symptoms, and mood. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite and Glucose Responses
- What is being tested?
- blended lentils, whole lentils and no lentils
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-55 years old
- Body mass index (BMI) 18.5-40 kg/m2
- Generally healthy
- A non-smoker
- Any ethnicity
- Free of chronic diseases and not taking medications or dietary supplements known to affect energy regulation or appetite
Who cannot join
- Beano drug label warnings including galactosemia, severe liver or kidney disease, allergies or sensitivities to any of the ingredients in Beano
- Peri and postmenopausal women
- Pregnant or lactating women (currently and within the past 1 year)
- Currently dieting or consuming unusual or a medically prescribed diet
- Net weight loss or gain (>5 lbs) within the last six months
- Consuming 1/2c per day or more of legumes, not including peanuts
Show all 12Show fewer
- Having taken Beano any time in the past 3 months
- Extreme problems digesting beans
- Fasting glucose >126 mg/dl
- Blood pressure >140/90 mmHg
- Moderate intensity or higher intensity exercise > 6 h/wk
- Predicted energy requirement < 2000 kcal/d or >4000 kcal/d
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Bean Form and Digestive Enzyme Availability on Postprandial Responses
The aim of this study is to determine the effects of bean physical form (whole versus blended) and Beano on postprandial responses. The postprandial responses the investigators will examine include blood glucose, appetite, metabolic rate, physical symptoms, and mood. To accomplish this aim the investigators will conduct a randomized, placebo-controlled trial in overweight and obese but otherwise healthy (non-diabetic) men and women
- Conditions
- Appetite and Glucose Responses
- Being tested
- blended lentils, whole lentils, no lentils
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blended lentilsOther
blended lentils burritto breakfast
whole lentilsOther
whole lentils breakfast burritto
no lentilsOther
No lentils control breakfast burritto
| Study group | Role | What they receive |
|---|---|---|
| alpha-gal & blended lentils | Experimental | 3 capsules of alpha-gal taken with blended lentils Receives: Other: blended lentils |
| alpha-gal & whole lentils | Experimental | 3 calpsules of alpha-gal taken with whole lentils Receives: Other: whole lentils |
| alpha-gal & no lentils | Experimental | 3 capsules of alpha-gal taken with no lentils control Receives: Other: no lentils |
| Placebo & blended lentils | Placebo comparator | 3 capsules of placebo taken with blended lentils Receives: Other: blended lentils |
| Placebo & whole lentils | Placebo comparator | 3 capsules of placebo taken with whole lentils Receives: Other: whole lentils |
| Placebo & no lentils | Placebo comparator | 3 capsules of placebo taken with no lentils control Receives: Other: no lentils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite
Subjects were given an appetite questionnaire to complete at time 0, 20, 40, 60, 120 and 180
Measured: 3 hours
Secondary outcomes (3)
Blood glucose
Finger prick blood were taken at time 0, 20, 40, 60, 120 and 180 for glucose measurement using a glucometer
Measured: 3 hours
fasting and postprandial energy expentidure
Fasting energy expenditure was measured for thirty minutes before meal and beano intervensions were given and at postprandial time points 20, 40, 60, 120 and 180, postprandial energy expenditure was measured for 15 minutes at each time point
Measured: 4 hours
gastrointestinal symptoms
At timepoints 0, 20, 40, 60, 120 and 180, gastroinstinal symptoms were assessed using a questionnaire
Measured: 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 Apr 2014 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
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 Appetite and Glucose ResponsesStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan McCrory, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110511
- Sponsor's protocol ID
- 1107011010
- Acronym
- BFE
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Anguah KO, Wonnell BS, Campbell WW, McCabe GP, McCrory MA. A blended- rather than whole-lentil meal with or without alpha-galactosidase mildly increases healthy adults' appetite but not their glycemic response. J Nutr. 2014 Dec;144(12):1963-9. doi: 10.3945/jn.114.195545. Epub 2014 Oct 8.
PubMed 25411033
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bean Form and Digestive Enzyme Availability on Postprandial Responses
- ClinicalTrials.gov ID
- NCT02110511
- Acronym / sponsor ID
- BFE / 1107011010
- Conditions
- Appetite and Glucose Responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Apr 2014 (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 aim of this study is to determine the effects of bean physical form (whole versus blended) and Beano on postprandial responses. The postprandial responses the investigators will examine include blood glucose, appetite, metabolic rate, physical symptoms, and mood. To accomplish this aim the investigators will conduct a randomized, placebo-controlled trial in overweight and obese but otherwise healthy (non-diabetic) men and women
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| alpha-gal & blended lentils | Experimental | Other: blended lentils3 capsules of alpha-gal taken with blended lentils |
| alpha-gal & whole lentils | Experimental | Other: whole lentils3 calpsules of alpha-gal taken with whole lentils |
| alpha-gal & no lentils | Experimental | Other: no lentils3 capsules of alpha-gal taken with no lentils control |
| Placebo & blended lentils | Placebo comparator | Other: blended lentils3 capsules of placebo taken with blended lentils |
| Placebo & whole lentils | Placebo comparator | Other: whole lentils3 capsules of placebo taken with whole lentils |
| Placebo & no lentils | Placebo comparator | Other: no lentils3 capsules of placebo taken with no lentils control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-55 years old
- Body mass index (BMI) 18.5-40 kg/m2
- Generally healthy
- A non-smoker
- Any ethnicity
Key exclusion criteria (12 listed)
- Beano drug label warnings including galactosemia, severe liver or kidney disease, allergies or sensitivities to any of the ingredients in Beano
- Peri and postmenopausal women
- Pregnant or lactating women (currently and within the past 1 year)
- Currently dieting or consuming unusual or a medically prescribed diet
- Net weight loss or gain (>5 lbs) within the last six months
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 |
|---|---|---|
| blended lentilsblended lentils burritto breakfast | Other | Placebo & blended lentils, alpha-gal & blended lentils |
| whole lentilswhole lentils breakfast burritto | Other | Placebo & whole lentils, alpha-gal & whole lentils |
| no lentilsNo lentils control breakfast burritto | Other | Placebo & no lentils, alpha-gal & no lentils |
Primary outcome
Appetite
Time frame: 3 hours
Subjects were given an appetite questionnaire to complete at time 0, 20, 40, 60, 120 and 180
3 secondary outcomes
Blood glucose
Time frame: 3 hours
fasting and postprandial energy expentidure
Time frame: 4 hours
gastrointestinal symptoms
Time frame: 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 Apr 2014.
- Derived from this study: PubMed 25411033Anguah KO, Wonnell BS, Campbell WW, McCabe GP, McCrory MA. A blended- rather than whole-lentil meal with or without alpha-galactosidase mildly increases healthy adults' appetite but not their glycemic response. J Nutr. 2014 Dec;144(12):1963-9. doi: 10.3945/jn.114.195545. Epub 2014 Oct 8.
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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 blended lentils, whole lentils and no lentils in people with Appetite and Glucose Responses, run by Purdue 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 6 inclusion and 12 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 Apr 2014. 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. 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?
Appetite (time frame: 3 hours). 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 NCT02110511, 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 10 Apr 2014.