Lepticore in Metabolic Syndrome and Weight Loss
Primary Purpose
Obesity, Hyperlipidemia, Hyperglycemia
Status
Completed
Phase
Phase 1
Locations
Cameroon
Study Type
Interventional
Intervention
Lepticore
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Obesity, metabolic syndrome, C-reactive protein, Leptin
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Laboratory of Nutrition and Nutritional Biochemistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lepticore
Arm Description
Outcomes
Primary Outcome Measures
Improvement of symptoms of metabolic syndrome
Secondary Outcome Measures
Change in weight
Full Information
NCT ID
NCT01046968
First Posted
January 11, 2010
Last Updated
January 11, 2010
Sponsor
University of Yaounde 1
Collaborators
Cameroon Nutritional Science Society
1. Study Identification
Unique Protocol Identification Number
NCT01046968
Brief Title
Lepticore in Metabolic Syndrome and Weight Loss
Official Title
The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Yaounde 1
Collaborators
Cameroon Nutritional Science Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hyperlipidemia, Hyperglycemia
Keywords
Obesity, metabolic syndrome, C-reactive protein, Leptin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lepticore
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Lepticore
Other Intervention Name(s)
Plant based polysaccharides
Intervention Description
300 mg twice daily
Primary Outcome Measure Information:
Title
Improvement of symptoms of metabolic syndrome
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in weight
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julius E Oben, PhD
Organizational Affiliation
University of Yaounde 1
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Nutrition and Nutritional Biochemistry
City
Yaounde
State/Province
Centre
ZIP/Postal Code
8418
Country
Cameroon
12. IPD Sharing Statement
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Lepticore in Metabolic Syndrome and Weight Loss
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