- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02110511
Body Responses to Bean Physical Form and "Beano" (BFE)
April 9, 2014 updated by: Megan McCrory, Purdue University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
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
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
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
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: alpha-gal & blended lentils
3 capsules of alpha-gal taken with blended lentils
|
blended lentils burritto breakfast
|
|
Experimental: alpha-gal & whole lentils
3 calpsules of alpha-gal taken with whole lentils
|
whole lentils breakfast burritto
|
|
Experimental: alpha-gal & no lentils
3 capsules of alpha-gal taken with no lentils control
|
No lentils control breakfast burritto
|
|
Placebo Comparator: Placebo & blended lentils
3 capsules of placebo taken with blended lentils
|
blended lentils burritto breakfast
|
|
Placebo Comparator: Placebo & whole lentils
3 capsules of placebo taken with whole lentils
|
whole lentils breakfast burritto
|
|
Placebo Comparator: Placebo & no lentils
3 capsules of placebo taken with no lentils control
|
No lentils control breakfast burritto
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite
Time Frame: 3 hours
|
Subjects were given an appetite questionnaire to complete at time 0, 20, 40, 60, 120 and 180
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose
Time Frame: 3 hours
|
Finger prick blood were taken at time 0, 20, 40, 60, 120 and 180 for glucose measurement using a glucometer
|
3 hours
|
|
fasting and postprandial energy expentidure
Time Frame: 4 hours
|
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
|
4 hours
|
|
gastrointestinal symptoms
Time Frame: 3 hours
|
At timepoints 0, 20, 40, 60, 120 and 180, gastroinstinal symptoms were assessed using a questionnaire
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
August 1, 2011
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
April 8, 2014
First Submitted That Met QC Criteria
April 9, 2014
First Posted (Estimate)
April 10, 2014
Study Record Updates
Last Update Posted (Estimate)
April 10, 2014
Last Update Submitted That Met QC Criteria
April 9, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 1107011010
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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