Lepticore in Metabolic Syndrome and Weight Loss

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome

Conditions
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Obesity, Hyperlipidemia, Hyperglycemia

Intervention / Treatment
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* Dietary Supplement: Lepticore


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lepticore<br> | Dietary Supplement: Lepticore<br>* 300 mg twice daily<br>* Other names: Plant based polysaccharides;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of symptoms of metabolic syndrome |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, metabolic syndrome, C-reactive protein, Leptin