ObesityNCT00198809
Use of Herbal Supplements in Weight Loss and Weight Maintenance
A study testing Biolean + Diet education and Biolean Free + Diet education in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Biolean + Diet education and Biolean Free + Diet education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Feb 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-60 years of age, overweight (Body Mass Index between 27-40) and desiring weight loss, normal EKG (electrocardiogram), not using or on a stable dosage of appetite- affecting medications (e.g., Prozac or other SSRIs, Synthroid, steroids), non-pregnant at screening by serum pregnancy test if female of childbearing capacity and using an acceptable method of birth control (tubal ligation, abstinence, properly used condom or diaphragm, oral or implanted contraceptives, or intrauterine device) To be considered not childbearing potential, participant must be at least one year post-menopausal or surgically sterile, willing and able to comply with the protocol requirements, willing and able to give informed consent, have a regular source of health care and permission of primary care provider.
Who cannot join
- Chronic health problems (not including obesity, allergies, skin problems, or occasional GERD or IBS symptoms). Participant may not have bulimia or laxative abuse, substance abuse, or alcohol intake > 10 oz. per week, or be under treatment for a psychiatric disorder (including depression, bipolar disorder, and anxiety determined by self-report during phone screening and the Beck Inventory survey to be completed during screening visit), as determined at screening. Use of ephedrine-containing products in the past 3 months, unwillingness to limit use of caffeinated beverages to three cups per day during participation in the study, active cigarette smoking of > 1 cigarette per week, resting systolic blood pressure > 140 mmHg or diastolic > 90 mmHg or pulse < 55 or > 100, and if female pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Biolean + Diet education, Biolean Free + Diet education, Placebo + Diet education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biolean + Diet educationDrug
Biolean Free + Diet educationDrug
Placebo + Diet educationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
blood pressure
pulse
blood
Secondary outcomes (2)
psychometrics
body composition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2002
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Wellness International, Ltd.
- Investigators
- Lawrence J Cheskin, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198809
- Sponsor's protocol ID
- WELL2001-01
- Status last verified
- Apr 2004
- First submitted
- 13 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Herbal Supplements in Weight Loss and Weight Maintenance
- ClinicalTrials.gov ID
- NCT00198809
- Acronym / sponsor ID
- WELL2001-01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 250 participants
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Wellness International, Ltd.
- Study start
- Nov 2002
- Study completion
- Feb 2004
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Between 18-60 years of age, overweight (Body Mass Index between 27-40) and desiring weight loss, normal EKG (electrocardiogram), not using or on a stable dosage of appetite- affecting medications (e.g., Prozac or other SSRIs, Synthroid, steroids), non-pregnant at screening by serum pregnancy test if female of childbearing capacity and using an acceptable method of birth control (tubal ligation, abstinence, properly used condom or diaphragm, oral or implanted contraceptives, or intrauterine device) To be considered not childbearing potential, participant must be at least one year post-menopausal or surgically sterile, willing and able to comply with the protocol requirements, willing and able to give informed consent, have a regular source of health care and permission of primary care provider.
Key exclusion criteria (1 listed)
- Chronic health problems (not including obesity, allergies, skin problems, or occasional GERD or IBS symptoms). Participant may not have bulimia or laxative abuse, substance abuse, or alcohol intake > 10 oz. per week, or be under treatment for a psychiatric disorder (including depression, bipolar disorder, and anxiety determined by self-report during phone screening and the Beck Inventory survey to be completed during screening visit), as determined at screening. Use of ephedrine-containing products in the past 3 months, unwillingness to limit use of caffeinated beverages to three cups per day during participation in the study, active cigarette smoking of > 1 cigarette per week, resting systolic blood pressure > 140 mmHg or diastolic > 90 mmHg or pulse < 55 or > 100, and if female pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biolean + Diet education | Drug | – |
| Biolean Free + Diet education | Drug | – |
| Placebo + Diet education | Drug | – |
Primary outcome
weight
blood pressure
pulse
blood
2 secondary outcomes
psychometrics
body composition
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence J Cheskin, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biolean + Diet education and Biolean Free + Diet education in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.