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
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
-
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.