Lepticore in Metabolic Syndrome and Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Cameroon Nutritional Science Society
Information provided by:
University of Yaounde 1
ClinicalTrials.gov Identifier:
NCT01046968
First received: January 11, 2010
Last updated: NA
Last verified: July 2009
History: No changes posted

January 11, 2010
January 11, 2010
August 2009
November 2009   (final data collection date for primary outcome measure)
Improvement of symptoms of metabolic syndrome [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Change in weight [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lepticore in Metabolic Syndrome and Weight Loss
The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
  • Obesity
  • Hyperlipidemia
  • Hyperglycemia
Dietary Supplement: Lepticore
300 mg twice daily
Other Name: Plant based polysaccharides
Experimental: Lepticore
Intervention: Dietary Supplement: Lepticore
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
19 Years to 52 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
NCT01046968
LNNB232
Yes
Pr. Julius Oben - Head of Laboratory of Nutrition & Nutritional Biochemistry, University of Yaounde 1
University of Yaounde 1
Cameroon Nutritional Science Society
Principal Investigator: Julius E Oben, PhD University of Yaounde 1
University of Yaounde 1
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP