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Lowering the glycaemic index of white bread using a white bean extract
ISRCTN ISRCTN50347345
DOI 10.1186/ISRCTN50347345
ClinicalTrials.gov identifier
EudraCT number
Public title Lowering the glycaemic index of white bread using a white bean extract
Scientific title Lowering the glycaemic index of white bread using a white bean extract: an open-label crossover study
Acronym N/A
Serial number at source PL900E
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).
Lay summary
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
Countries of recruitment United States of America
Disease/condition/study domain Glycaemic index measurements
Participants - 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
Participants - exclusion criteria 1. Any active eating disorders
2. Gastrointestinal illness
3. History of gastrointestinal surgery, diabetes or other endocrinological disorders
Anticipated start date 01/04/2005
Anticipated end date 01/11/2005
Status of trial Completed
Patient information material
Target number of participants 16
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding Pharmachem Laboratories, Inc (USA)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19860922
Contact name Dr  Jay  Udani
  Address 18250 Roscoe Blvd. Suite 240
  City/town Northridge
  Zip/Postcode 91325
  Country United States of America
Sponsor Pharmachem Laboratories, Inc (USA)
  Address 265 Harrison Avenue
  City/town Kearny, NJ
  Zip/Postcode 07032
  Country United States of America
  Sponsor website: http://www.pharmachemlabs.com/
Date applied 21/07/2009
Last edited 22/01/2010
Date ISRCTN assigned 19/08/2009
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