NCT02110511

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

April 8, 2014

Last Update Submit

April 9, 2014

Conditions

Appetite and Glucose Responses

Outcome Measures

Primary Outcomes (1)

  • Appetite

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

    3 hours

Secondary Outcomes (3)

  • Blood glucose

    3 hours

  • fasting and postprandial energy expentidure

    4 hours

  • gastrointestinal symptoms

    3 hours

Study Arms (6)

alpha-gal & blended lentils

EXPERIMENTAL

3 capsules of alpha-gal taken with blended lentils

Other: blended lentils

alpha-gal & whole lentils

EXPERIMENTAL

3 calpsules of alpha-gal taken with whole lentils

Other: whole lentils

alpha-gal & no lentils

EXPERIMENTAL

3 capsules of alpha-gal taken with no lentils control

Other: no lentils

Placebo & blended lentils

PLACEBO COMPARATOR

3 capsules of placebo taken with blended lentils

Other: blended lentils

Placebo & whole lentils

PLACEBO COMPARATOR

3 capsules of placebo taken with whole lentils

Other: whole lentils

Placebo & no lentils

PLACEBO COMPARATOR

3 capsules of placebo taken with no lentils control

Other: no lentils

Interventions

blended lentilsOTHER

blended lentils burritto breakfast

Placebo & blended lentilsalpha-gal & blended lentils
whole lentilsOTHER

whole lentils breakfast burritto

Placebo & whole lentilsalpha-gal & whole lentils
no lentilsOTHER

No lentils control breakfast burritto

Placebo & no lentilsalpha-gal & no lentils

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

    PMID: 25411033DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 10, 2014

Study Start

August 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 10, 2014

Record last verified: 2014-04

Locations

US(1)