ObesityPhase 1/2NCT01046968
Lepticore in Metabolic Syndrome and Weight Loss
A Phase 1/2 study testing Lepticore in people with Obesity and Hyperlipidemia, run by University of Yaounde 1 at 1 site in Cameroon.
Trial summary
Metabolic syndrome is directly related to obesity. This study investigated the use of a plant based formulation to improve on the condition of people with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 19 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hyperlipidemia, Hyperglycemia
- What is being tested?
- Lepticore
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCameroon
- Study dates
- Aug 2009to Nov 2009
- Phase
- Phase 1/2
- 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 19 to 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >30 kg/m2
- Total cholesterol >200 mg/dl
- LDL cholesterol >160 mg/dl
- HDL cholesterol <40 mg/dl; triglycerides >150 mg/dl
- Fasting blood glucose >100 mg/dl
- Blood pressure >130/85 mmHg.
Who cannot join
- Morbid obesity (BMI >40 kg/m2 )
- Diabetes mellitus requiring daily insulin management
- Pregnancy/lactation
- Active infection
- Systemic disease such as HIV/AIDS,
- Use of any cholesterol-lowering medications 30 days prior to study
- Enrollment in another clinical study within the past 6 months.
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Laboratory of Nutrition and Nutritional Biochemistry
Yaoundé, Centre Region, 8418
About this study
Official title: The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome
Metabolic syndrome is directly related to obesity. This study investigated the use of a plant based formulation to improve on the condition of people with metabolic syndrome.
Read the detailed description
LeptiCore is a proprietary combination of various ingredients which have been shown to have properties which could be beneficial to weight loss in obese and overweight human subjects. This study evaluates the effect of Lepticore on bodyweight as well as parameters associated with obesity and metabolic syndrome.
The study was an 8 week randomized, double-blind, placebo-controlled design involving 92 obese (mean BMI>30kg/m2) participants (37 males; 55 females; ages 19-52; mean age = 30.7). The participants were randomly divided into three groups: placebo (n=30), LeptiCore formula A (low dose) (n=31) and LeptiCore formula B (high dose) (n=31). Capsules containing the placebo or active formulations were administered twice daily before meals with 300 ml of water. None of the participants followed any specific diet nor took any weight-reducing medications for the duration of the study. A total of 12 anthropomorphic and serological measurements were taken at the beginning of the study and after 2, 4, 6, and 8 weeks of treatment.
- Conditions
- Obesity, Hyperlipidemia, Hyperglycemia
- Being tested
- Lepticore
- Keywords
- Obesity, metabolic syndrome, C-reactive protein, Leptin
- Medical subject headings
- Obesity, Hyperlipidemias, Hyperglycemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LepticoreDietary supplement
Also called Plant based polysaccharides
300 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Lepticore | Experimental | Not described Receives: Dietary Supplement: Lepticore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptoms of metabolic syndrome
Measured: 8 weeks
Secondary outcomes (1)
Change in weight
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionNov 2009
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.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yaounde 1
- Sponsor type
- University, hospital or other
- Collaborators
- Cameroon Nutritional Science Society
- Investigators
- Julius E Oben, PhD, Principal investigator, University of Yaounde 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046968
- Sponsor's protocol ID
- LNNB232
- Status last verified
- Jul 2009
- First submitted
- 11 Jan 2010
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01046968
- Acronym / sponsor ID
- LNNB232
- Conditions
- Obesity, Hyperlipidemia, Hyperglycemia
- Keywords
- Obesity, metabolic syndrome, C-reactive protein, Leptin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Yaounde 1University, hospital or other
- Collaborators
- Cameroon Nutritional Science Society
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Jan 2010 (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.
Metabolic syndrome is directly related to obesity. This study investigated the use of a plant based formulation to improve on the condition of people with metabolic syndrome.
Detailed description
LeptiCore is a proprietary combination of various ingredients which have been shown to have properties which could be beneficial to weight loss in obese and overweight human subjects. This study evaluates the effect of Lepticore on bodyweight as well as parameters associated with obesity and metabolic syndrome.
The study was an 8 week randomized, double-blind, placebo-controlled design involving 92 obese (mean BMI>30kg/m2) participants (37 males; 55 females; ages 19-52; mean age = 30.7). The participants were randomly divided into three groups: placebo (n=30), LeptiCore formula A (low dose) (n=31) and LeptiCore formula B (high dose) (n=31). Capsules containing the placebo or active formulations were administered twice daily before meals with 300 ml of water. None of the participants followed any specific diet nor took any weight-reducing medications for the duration of the study. A total of 12 anthropomorphic and serological measurements were taken at the beginning of the study and after 2, 4, 6, and 8 weeks of treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lepticore | Experimental | Dietary Supplement: Lepticore |
Who may qualify
- Ages
- 19 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI >30 kg/m2
- Total cholesterol >200 mg/dl
- LDL cholesterol >160 mg/dl
- HDL cholesterol <40 mg/dl; triglycerides >150 mg/dl
- Fasting blood glucose >100 mg/dl
Key exclusion criteria (7 listed)
- Morbid obesity (BMI >40 kg/m2 )
- Diabetes mellitus requiring daily insulin management
- Pregnancy/lactation
- Active infection
- Systemic disease such as HIV/AIDS,
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 |
|---|---|---|
| LepticoreAlso: Plant based polysaccharides300 mg twice daily | Dietary supplement | Lepticore |
Primary outcome
Improvement of symptoms of metabolic syndrome
Time frame: 8 weeks
1 secondary outcome
Change in weight
Time frame: 8 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 12 Jan 2010.
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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.
Julius E Oben, PhD principal investigator
University of Yaounde 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lepticore in people with Obesity and Hyperlipidemia, run by University of Yaounde 1 at 1 site in Cameroon.
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 6 inclusion and 7 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 12 Jan 2010. 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 Cameroon. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement of symptoms of metabolic syndrome (time frame: 8 weeks). 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 12 Jan 2010.