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

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.

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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