Condition category
Not Applicable
Date applied
21/07/2009
Date assigned
19/08/2009
Last edited
22/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jay Udani

ORCID ID

Contact details

18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PL900E

Study information

Scientific title

Lowering the glycaemic index of white bread using a white bean extract: an open-label crossover study

Acronym

Study hypothesis

The hypothesis of this study was that a white bean preparation could lower the effective glycaemic index of a high glycaemic food (white bread).

Ethics approval

IRB approval was obtained from the Copernicus Group (Cary, NC) in December 2004 (ref: IHR1-04-147)

Study design

Open-label six-arm crossover study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Glycaemic index measurements

Intervention

This is an open-label six-arm crossover study with 13 randomised healthy adults. Standardised testing of the glycaemic index was performed on white bread with and without the addition of the white bean preparation in several doses formulated in capsules or in powder form. The study was conducted at a single site Medicus Research Clinical Research Center, Northridge, CA, USA.

The white bean preparation was a water extract of the white kidney bean (Phaseolus vulgaris) standardised to alpha-amylase (8; 12; 15; 39) inhibiting units (Pharmachem Laboratories, Kearny, NJ). The white bread was Wonder brand (Interstate Bakeries, Kansas City, MO). Subjects reported to the study centre seven times during which they received 50 g net carbohydrates in the form of white bread with butter either by itself or with a form of extract. The test product was given at dosages of 1500 mg, 2000 mg, and 3000 mg in capsule form and 1500 mg, 2000 mg, and 3000 mg in powder form. The powder form of the test product was mixed into the butter which was spread on the bread. The capsules were taken immediately prior to the ingestion of food.

Intervention type

Drug

Phase

Phase II

Drug names

White bean extract

Primary outcome measures

Glycaemic index calculated according to the Food and Agriculture Organization (FAO)/World Health Organization (WHO) standard, using capillary blood glucose measurements.

Glucose measured seven times over 2 hours on each study day.

Secondary outcome measures

Tolerability of the white bean extract measured using 10 point Likert scales for diarrhoea, flatulence, abdominal bloating, abdominal cramping, nausea, boborygmi (bowel sounds) and soft stools.

Glucose measured seven times over 2 hours on each study day.

Overall trial start date

01/04/2005

Overall trial end date

01/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 24 and 44 years, males only
2. Body mass index (BMI) between 18 and 25 (kg/m^2)
3. Fasting glucose levels less than or equal to 100 mg/dL
4. Agreed to all study visits and procedures
5. Agreed to use appropriate forms of birth control if females of child bearing potential

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

16

Participant exclusion criteria

1. Any active eating disorders
2. Gastrointestinal illness
3. History of gastrointestinal surgery, diabetes or other endocrinological disorders

Recruitment start date

01/04/2005

Recruitment end date

01/11/2005

Locations

Countries of recruitment

United States of America

Trial participating centre

18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America

Sponsor information

Organisation

Pharmachem Laboratories, Inc (USA)

Sponsor details

265 Harrison Avenue
Kearny
NJ
07032
United States of America

Sponsor type

Industry

Website

http://www.pharmachemlabs.com/

Funders

Funder type

Industry

Funder name

Pharmachem Laboratories, Inc (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19860922

Publication citations

  1. Results

    Udani JK, Singh BB, Barrett ML, Preuss HG, Lowering the glycemic index of white bread using a white bean extract., Nutr J, 2009, 8, 52, doi: 10.1186/1475-2891-8-52.

Additional files

Editorial Notes