Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/11/2004
Date assigned
08/12/2004
Last edited
08/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jay Udani

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Overweight

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Phase 2® brand proprietary fractionated white bean extract

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2000

Overall trial end date

31/05/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant 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

Recruitment start date

01/04/2000

Recruitment end date

31/05/2002

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

Sponsor details

265 Harrison Ave.
Kearny
07032
United States of America

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Research Grant from Pharmachem Laboratories

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

Publication citations

Additional files

Editorial Notes