Lepticore in Metabolic Syndrome and Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046968
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : January 12, 2010
Cameroon Nutritional Science Society
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Obesity Hyperlipidemia Hyperglycemia Dietary Supplement: Lepticore Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome
Study Start Date : August 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: Lepticore Dietary Supplement: Lepticore
300 mg twice daily
Other Name: Plant based polysaccharides

Primary Outcome Measures :
  1. Improvement of symptoms of metabolic syndrome [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in weight [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 52 Years   (Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01046968

Laboratory of Nutrition and Nutritional Biochemistry
Yaounde, Centre, Cameroon, 8418
Sponsors and Collaborators
University of Yaounde 1
Cameroon Nutritional Science Society
Principal Investigator: Julius E Oben, PhD University of Yaounde 1

Responsible Party: Pr. Julius Oben - Head of Laboratory of Nutrition & Nutritional Biochemistry, University of Yaounde 1 Identifier: NCT01046968     History of Changes
Other Study ID Numbers: LNNB232
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: July 2009

Keywords provided by University of Yaounde 1:
metabolic syndrome
C-reactive protein

Additional relevant MeSH terms:
Weight Loss
Metabolic Syndrome X
Body Weight Changes
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders