|
ISRCTN
|
ISRCTN87421612
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Blocking carbohydrate absorption and weight loss: a clinical trial using the phase 2® brand proprietary fractionated white bean extract
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United States of America
|
|
Disease/condition/study domain
|
Overweight
|
|
Participants - inclusion criteria
|
1. Aged over 18 and under 40 at screening
2. Body Mass Index (BMI) more than or equal to 23kg/m^2 and less than 31 kg/m^2 at screening
3. Agreement to maintain diet, exercise and behavioral modification guidelines while participating in the study
4. Agreement to periodic follow-up
5. Females agreement to use appropriate birth control methods during the active study
|
|
Participants - exclusion criteria
|
1. Use of any drugs, herbs or other non-prescription preparations for obesity within four weeks of screening including, but not limited to, Sibutramine, Orlistat, Phen-Fen, Metabolife, diuretics etc
2. Abnormal electrocardiogram (EKG), Complete Blood Count (CBC), metabolic panel, or physical examination
3. An active eating disorder
4. Severe hepatic or renal disease
5. History of seizure, alcohol abuse, chronic malabsorption, diverticulosis or diverticulitis
6. Diagnosis of coronary artery disease, congestive heart failure, stroke, arrhythmia, or uncontrolled hypertension
7. Pregnancy or lactation
8. Inability to understand or follow the study protocol
9. Diagnosis of significant psychiatric disease or depression
10. Known sensitivities to the product
|
|
Anticipated start date
|
01/04/2000
|
|
Anticipated end date
|
31/05/2002
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
After this screening period, participants were randomly allocated to receive either the Phase 2® brand proprietary fractionated white bean extract or identical placebo in a double-blind manner. Assessors and participants were blinded to group assignment.
Two people dropped out after having been randomised. One withdrew from the study before receiving any product and another withdrew after receiving product but without ingesting it or following other protocol requirements. These persons are not included in the data analysis.
Phase 2® was administered in the form of a 500 mg capsule. A capsule of identical appearance, texture, taste, and smell was used as the placebo. Participants were advised to take two capsules (1000 mg) at the beginning of breakfast and lunch each day. No other drugs, herbs, or non-prescription products for obesity were allowed during the study.
An intensive dietary intervention including personalised diet instructions and prepared food was provided. Participants in both groups were supplied with supplemental foods which met the diet parameters to facilitate compliance and to avoid having diet restrictions produce a financial burden for participants. Breakfast and lunch were provided on a daily basis and dinners were prepared along dietary guidelines by participants. They were instructed to maintain a caloric intake of 1800 calories. Additionally, they also received a personalised exercise regimen which instructed them to exercise at least one half hour, four times a week. Finally, subjects received weekly group behavioral therapy sessions in order to problem-solve personal eating issues.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Research Grant from Pharmachem Laboratories
|
|
Trial website
|
|
|
Publications
|
|
|
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
|
|
Address
|
265 Harrison Ave.
|
|
City/town
|
Kearny
|
|
Zip/Postcode
|
07032
|
|
Country
|
United States of America
|
|
Date applied
|
29/11/2004
|
|
Last edited
|
08/09/2011
|
|
Date ISRCTN assigned
|
08/12/2004
|
