Lepticore in Metabolic Syndrome and Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046968
• Other study ID #: LNNB232
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 11, 2010
• Last updated: January 11, 2010
• Start date: August 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2009
• Source: University of Yaounde 1
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 52 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperglycemia
• Hyperlipidemia
• Hyperlipidemias
• Metabolic Syndrome X
• Obesity

Intervention

Dietary Supplement:
• Lepticore
300 mg twice daily

Locations

Country	Name	City	State
Cameroon	Laboratory of Nutrition and Nutritional Biochemistry	Yaounde	Centre

Sponsors (2)

Lead Sponsor	Collaborator
University of Yaounde 1	Cameroon Nutritional Science Society

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of symptoms of metabolic syndrome		8 weeks	No
Secondary	Change in weight		8 weeks	No