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
  Purpose

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 Intervention Phase
Obesity
Hyperlipidemia
Hyperglycemia
Dietary Supplement: Lepticore
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Yaounde 1:

Primary Outcome Measures:
  • Improvement of symptoms of metabolic syndrome [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in weight [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: August 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lepticore Dietary Supplement: Lepticore
300 mg twice daily
Other Name: Plant based polysaccharides

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.

  Eligibility

Ages Eligible for Study:   19 Years to 52 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046968

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

No publications provided

Responsible Party: Pr. Julius Oben - Head of Laboratory of Nutrition & Nutritional Biochemistry, University of Yaounde 1
ClinicalTrials.gov Identifier: NCT01046968     History of Changes
Other Study ID Numbers: LNNB232
Study First Received: January 11, 2010
Last Updated: January 11, 2010
Health Authority: Cameroon: Ministry of Public Health

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

Additional relevant MeSH terms:
Hyperglycemia
Hyperlipidemias
Obesity
Weight Loss
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on April 23, 2014