Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198809
Status:
TERMINATED
Last Update Posted:
2005-09-20
First Post:
2005-09-13
Brief Title:
Use of Herbal Supplements in Weight Loss and Weight Maintenance
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Use of Herbal Supplements in Weight Loss and Weight Maintenance
Status:
TERMINATED
Status Verified Date:
2004-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Effects of herbal products on weight loss weight maintenance and metabolic rate
The objective of this study is to evaluate the efficacy of two herbal weight loss products BioLean and BioLean Free compared to each other and a matching placebo in effects on appetite suppression changes in metabolism weight loss and safety in overweight men and women over a 12 month active weight loss and weight maintenance program
This is a randomized double-blind study The planned sample size is 180 healthy overweight BMI 27-40 males and females aged 18-60
The objective of this study is to evaluate the efficacy of two herbal weight loss products BioLean and BioLean Free compared to each other and a matching placebo in effects on appetite suppression changes in metabolism weight loss and safety in overweight men and women over a 12 month active weight loss and weight maintenance program
This is a randomized double-blind study The planned sample size is 180 healthy overweight BMI 27-40 males and females aged 18-60
Detailed Description:
The study data collection will occur in two phases active weight loss phase 1 and weight maintenance phase 2 Transition into phase 2 will be individually determined by participant attainment of a goal healthy weight During the 52 weeks participants will pick up supplemental pills have weight measured and meet for educational meeting on an every other week basis Upon entering phase 2 participants will have the option of educational sessions on a monthly basis or every other week Participants will have a goal healthy weight determined at baseline by a combination of personal goals Harris Benedict Equation goals body composition goals and BMI range All participants will be put on a weight reduction plan to reach these goals and be randomly assigned to one of 3 treatment groups Biolean Biolean Free or Placebo Since it is expected some participants will reach goal weight before others the 2nd milestone data collection will occur at attainment of goal weight To assure all participants have 3 data collection points any participant who is not expected to reasonably reach their goal weight by 34 weeks will have the 2nd milestone data collection at 26 weeks The 3rd milestone data collection for all participants is 52 weeks after initial intake of supplement Upon attainment of goal weight and 2nd data collection point participants will be educated on a weight maintenance plan and given a new meal plan to achieve long term healthy weight maintenance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None