Lowering the glycaemic index of white bread using a white bean extract
| ISRCTN | ISRCTN50347345 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50347345 |
| Protocol serial number | PL900E |
| Sponsor | Pharmachem Laboratories, Inc (USA) |
| Funder | Pharmachem Laboratories, Inc (USA) |
- 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
Scientific
18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label six-arm crossover study |
| Secondary study design | Non randomised controlled trial |
| Scientific title | Lowering the glycaemic index of white bread using a white bean extract: an open-label crossover study |
| Study objectives | 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(s) | IRB approval was obtained from the Copernicus Group (Cary, NC) in December 2004 (ref: IHR1-04-147) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | White bean extract |
| 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. |
| Key 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. |
| Completion date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 16 |
| Key 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 |
| Key exclusion criteria | 1. Any active eating disorders 2. Gastrointestinal illness 3. History of gastrointestinal surgery, diabetes or other endocrinological disorders |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 01/11/2005 |
Locations
Countries of recruitment
- United States of America
Study participating centre
18250 Roscoe Blvd. Suite 240
Northridge
91325
United States of America
91325
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
