ObesityNCT01710722
The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man
A study testing caffeine and ephedrine, Leptin A and caffeine, ephedrine, and leptin A in people with Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to compare three treatments to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol. 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?
- caffeine and ephedrine, Leptin A and caffeine, ephedrine, and leptin A
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Feb 2002
- 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
- You are healthy.
- You are not pregnant or nursing.
- You are between 18 and 60 years of age.
- You have a body mass index, calculated from your height and weight, of 30 to 40 kg/m2.
Who cannot join
- You take chronic medications except hormone replacement or contraception.
- You are a woman and are unwilling to use effective contraception during the trial.
- You have blood pressure higher than 150/90.
- You have heart disease.
- You have urinary symptoms from an enlarged prostate.
- You have gained or lost more than 10 pounds in the last 6 months.
Show all 10Show fewer
- You have used a monoamine oxidase inhibitor medication in the last month.
- You have high or low thyroid function that has not been controlled in the normal range for at least 2 months.
- You have heart disease or a history of stroke.
- You have a known sensitivity to E. coli or E. coli derived products.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The purpose of this study is to compare three treatments to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.
Read the detailed description
Three treatments are compared to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.
- Leptin A-200 injections daily with 2 inactive pills taken three times a day, 2) Caffeine with ephedrine pills taken 3 times a day with an inactive injection daily and 3) Both Leptin A-200 injections daily and caffeine with ephedrine pills taken three times a day.
- Conditions
- Obesity
- Being tested
- caffeine and ephedrine, Leptin A, caffeine, ephedrine, and leptin A
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeine and ephedrineDrug
Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.
Leptin ADrug
Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.
caffeine, ephedrine, and leptin ADrug
Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.
| Study group | Role | What they receive |
|---|---|---|
| caffeine and ephedrine | Experimental | Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily. Receives: Drug: caffeine and ephedrine |
| leptin A | Experimental | Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day. Receives: Drug: Leptin A |
| caffeine, ephedrine, and leptin A | Experimental | Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily. Receives: Drug: caffeine, ephedrine, and leptin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine.
Measured: 28 weeks
Secondary outcomes (30)
Compare the loss of fat and lean tissue with leptin alone.
Measured: 28 Weeks
To compare the loss of fat and lean tissue with caffeine with ephedrine alone.
Measured: 28 Weeks
compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination.
Measured: 28 Weeks
To compare weight loss with leptin alone.
Measured: 28 Weeks
To compare weight loss caffeine with ephedrine alone.
Measured: 28 Weeks
To compare weight loss with leptin, ephedrine and caffeine combination.
Measured: 28 Weeks
To compare the changes in insulin, with leptin alone.
Measured: 28 Weeks
To compare the changes in insulin, with caffeine with ephedrine alone
Measured: 28 Weeks
To compare the changes in insulin, with leptin , ephedrine and caffeine combination.
Measured: 28 Weeks
To compare the changes in triglycerides, with leptin alone.
Measured: 28 Weeks
To compare the changes in triglycerides, caffeine with ephedrine alone.
Measured: 28 Weeks
To compare the changes in triglycerides, with leptin , ephedrine and caffeine combination
Measured: 28 Weeks
To compare the changes in cholesterol, with leptin alone.
Measured: 28 Weeks
To compare the changes in cholesterol, caffeine with ephedrine alone.
Measured: 28 Weeks
To compare the changes in cholesterol with leptin , ephedrine and caffeine combination
Measured: 28 Weeks
To compare the changes in HDL cholesterol, with leptin alone.
Measured: 28 Weeks
To compare the changes in HDL cholesterol, caffeine with ephedrine alone.
Measured: 28 Weeks
To compare the changes in HDL cholesterol, with leptin , ephedrine and caffeine combination
Measured: 28 Weeks
To compare the changes in LDL cholesterol, with leptin alone.
Measured: 28 Weeks
To compare the changes in LDL cholesterol, caffeine with ephedrine alone.
Measured: 28 Weeks
To compare the changes in LDL cholesterol, with leptin , ephedrine and caffeine combination
Measured: 28 Weeks
To compare the changes in glucose, with leptin alone.
Measured: 28 Weeks
To compare the changes in glucose, caffeine with ephedrine alone.
Measured: 28 Weeks
To compare the changes in glucose, with leptin , ephedrine and caffeine combination
Measured: 28 Weeks
To compare the changes in uric acid, with leptin alone.
Measured: 28 Weeks
To compare the changes in uric acid, caffeine with ephedrine alone.
Measured: 28 Weeks
To compare the changes in uric acid, with leptin , ephedrine and caffeine combination
Measured: 28 Weeks
To compare the changes in Alanine Aminotransferase (ALT )with leptin alone.
Measured: 28 Weeks
To compare the changes in Alanine Aminotransferase (ALT ) caffeine with ephedrine alone.
Measured: 28 Weeks
To compare the changes in Alanine Aminotransferase (ALT ) with leptin , ephedrine and caffeine combination
Measured: 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startFeb 2001
- Primary completionFeb 2002
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710722
- Sponsor's protocol ID
- PBRC 20034
- Status last verified
- Dec 2015
- First submitted
- 17 Oct 2012
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu AG, Smith SR, Fujioka K, Greenway FL. The effect of leptin, caffeine/ephedrine, and their combination upon visceral fat mass and weight loss. Obesity (Silver Spring). 2013 Oct;21(10):1991-6. doi: 10.1002/oby.20416. Epub 2013 Jun 11.
PubMed 23686786
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man
- ClinicalTrials.gov ID
- NCT01710722
- Acronym / sponsor ID
- PBRC 20034
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Feb 2001
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 19 Oct 2012 (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.
The purpose of this study is to compare three treatments to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.
Detailed description
Three treatments are compared to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.
- Leptin A-200 injections daily with 2 inactive pills taken three times a day, 2) Caffeine with ephedrine pills taken 3 times a day with an inactive injection daily and 3) Both Leptin A-200 injections daily and caffeine with ephedrine pills taken three times a day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| caffeine and ephedrine | Experimental | Drug: caffeine and ephedrineCaffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily. |
| leptin A | Experimental | Drug: Leptin ALeptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day. |
| caffeine, ephedrine, and leptin A | Experimental | Drug: caffeine, ephedrine, and leptin ACaffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- You are healthy.
- You are not pregnant or nursing.
- You are between 18 and 60 years of age.
- You have a body mass index, calculated from your height and weight, of 30 to 40 kg/m2.
Key exclusion criteria (10 listed)
- You take chronic medications except hormone replacement or contraception.
- You are a woman and are unwilling to use effective contraception during the trial.
- You have blood pressure higher than 150/90.
- You have heart disease.
- You have urinary symptoms from an enlarged prostate.
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 |
|---|---|---|
| caffeine and ephedrineCaffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily. | Drug | caffeine and ephedrine |
| Leptin ALeptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day. | Drug | leptin A |
| caffeine, ephedrine, and leptin ACaffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily. | Drug | caffeine, ephedrine, and leptin A |
Primary outcome
Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine.
Time frame: 28 weeks
30 secondary outcomes
Compare the loss of fat and lean tissue with leptin alone.
Time frame: 28 Weeks
To compare the loss of fat and lean tissue with caffeine with ephedrine alone.
Time frame: 28 Weeks
compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination.
Time frame: 28 Weeks
To compare weight loss with leptin alone.
Time frame: 28 Weeks
To compare weight loss caffeine with ephedrine alone.
Time frame: 28 Weeks
To compare weight loss with leptin, ephedrine and caffeine combination.
Time frame: 28 Weeks
To compare the changes in insulin, with leptin alone.
Time frame: 28 Weeks
To compare the changes in insulin, with caffeine with ephedrine alone
Time frame: 28 Weeks
To compare the changes in insulin, with leptin , ephedrine and caffeine combination.
Time frame: 28 Weeks
To compare the changes in triglycerides, with leptin alone.
Time frame: 28 Weeks
To compare the changes in triglycerides, caffeine with ephedrine alone.
Time frame: 28 Weeks
To compare the changes in triglycerides, with leptin , ephedrine and caffeine combination
Time frame: 28 Weeks
To compare the changes in cholesterol, with leptin alone.
Time frame: 28 Weeks
To compare the changes in cholesterol, caffeine with ephedrine alone.
Time frame: 28 Weeks
To compare the changes in cholesterol with leptin , ephedrine and caffeine combination
Time frame: 28 Weeks
To compare the changes in HDL cholesterol, with leptin alone.
Time frame: 28 Weeks
To compare the changes in HDL cholesterol, caffeine with ephedrine alone.
Time frame: 28 Weeks
To compare the changes in HDL cholesterol, with leptin , ephedrine and caffeine combination
Time frame: 28 Weeks
To compare the changes in LDL cholesterol, with leptin alone.
Time frame: 28 Weeks
To compare the changes in LDL cholesterol, caffeine with ephedrine alone.
Time frame: 28 Weeks
To compare the changes in LDL cholesterol, with leptin , ephedrine and caffeine combination
Time frame: 28 Weeks
To compare the changes in glucose, with leptin alone.
Time frame: 28 Weeks
To compare the changes in glucose, caffeine with ephedrine alone.
Time frame: 28 Weeks
To compare the changes in glucose, with leptin , ephedrine and caffeine combination
Time frame: 28 Weeks
To compare the changes in uric acid, with leptin alone.
Time frame: 28 Weeks
To compare the changes in uric acid, caffeine with ephedrine alone.
Time frame: 28 Weeks
To compare the changes in uric acid, with leptin , ephedrine and caffeine combination
Time frame: 28 Weeks
To compare the changes in Alanine Aminotransferase (ALT )with leptin alone.
Time frame: 28 Weeks
To compare the changes in Alanine Aminotransferase (ALT ) caffeine with ephedrine alone.
Time frame: 28 Weeks
To compare the changes in Alanine Aminotransferase (ALT ) with leptin , ephedrine and caffeine combination
Time frame: 28 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Derived from this study: PubMed 23686786Liu AG, Smith SR, Fujioka K, Greenway FL. The effect of leptin, caffeine/ephedrine, and their combination upon visceral fat mass and weight loss. Obesity (Silver Spring). 2013 Oct;21(10):1991-6. doi: 10.1002/oby.20416. Epub 2013 Jun 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine and ephedrine, Leptin A and caffeine, ephedrine, and leptin A in people with Obesity, run by Pennington Biomedical Research Center 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 18 Dec 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine. (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710722, which also lists 1 linked publication.
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 18 Dec 2015.