The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- Improvement of symptoms of metabolic syndrome
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 19 Years to 52 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Improvement of symptoms of metabolic syndrome
Time Frame: 8 weeks
Secondary Outcomes
- Change in weight(8 weeks)