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OpenTrials
Completed

NCT Number: NCT02110511

Body Responses to Bean Physical Form and "Beano"

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blended lentils

Other

blended lentils burritto breakfast

whole lentils

Other

whole lentils breakfast burritto

no lentils

Other

No lentils control breakfast burritto

Primary outcomes

  1. Appetite

    Time frame: 3 hours

    Subjects were given an appetite questionnaire to complete at time 0, 20, 40, 60, 120 and 180

Secondary outcomes

  1. 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

  2. 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

  3. gastrointestinal symptoms

    Time frame: 3 hours

    At timepoints 0, 20, 40, 60, 120 and 180, gastroinstinal symptoms were assessed using a questionnaire

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Official study title

Effects of Bean Form and Digestive Enzyme Availability on Postprandial Responses

Acronym: BFE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 10, 2014
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.