Lepticore in Metabolic Syndrome and Weight Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-11-30

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.

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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.

Conditions

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Obesity Hyperlipidemia Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Lepticore

Group Type EXPERIMENTAL

Lepticore

Intervention Type DIETARY_SUPPLEMENT

300 mg twice daily

Interventions

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Lepticore

300 mg twice daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Plant based polysaccharides

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

52 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes