Lowering the glycaemic index of white bread using a white bean extract

ISRCTN ISRCTN50347345
DOI https://doi.org/10.1186/ISRCTN50347345
Secondary identifying numbers PL900E
Submission date
21/07/2009
Registration date
19/08/2009
Last edited
22/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jay Udani
Scientific

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

Study information

Study designOpen-label six-arm crossover study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleLowering the glycaemic index of white bread using a white bean extract: an open-label crossover study
Study objectivesThe 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(s)IRB approval was obtained from the Copernicus Group (Cary, NC) in December 2004 (ref: IHR1-04-147)
Health condition(s) or problem(s) studiedGlycaemic index measurements
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)White bean extract
Primary outcome measureGlycaemic 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 measuresTolerability 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 study start date01/04/2005
Completion date01/11/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants16
Key inclusion criteria1. 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
Key exclusion criteria1. Any active eating disorders
2. Gastrointestinal illness
3. History of gastrointestinal surgery, diabetes or other endocrinological disorders
Date of first enrolment01/04/2005
Date of final enrolment01/11/2005

Locations

Countries of recruitment

  • United States of America

Study participating centre

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

Sponsor information

Pharmachem Laboratories, Inc (USA)
Industry

265 Harrison Avenue
Kearny, NJ
07032
United States of America

Website http://www.pharmachemlabs.com/
ROR logo "ROR" https://ror.org/02ygftm07

Funders

Funder type

Industry

Pharmachem Laboratories, Inc (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 28/10/2009 Yes No