Lepticore in Metabolic Syndrome and Weight Loss

Phase 1

Completed

• Conditions: Obesity; Hyperlipidemia; Hyperglycemia
• Interventions: Dietary Supplement: Lepticore

• Registration Number: NCT01046968
• Lead Sponsor: University of Yaounde 1

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 Timeline

• Status Verified: 2009-07
• Study Start: 2009-08
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Last Update Submitted: 2010-01-11
• Study First Posted: 2010-01-12
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lepticore	Lepticore	-

Primary Outcome Measures

Name	Time	Method
Improvement of symptoms of metabolic syndrome	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in weight	8 weeks

Trial Locations

Locations (1)

Laboratory of Nutrition and Nutritional Biochemistry; 🇨🇲 Yaounde, Centre, Cameroon