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Completed

NCT Number: NCT01046968

Lepticore in Metabolic Syndrome and Weight Loss

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.

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Key information

Age range

19 year–52 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Laboratory of Nutrition and Nutritional Biochemistry

Yaoundé, Centre Region, 8418, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lepticore

Dietary Supplement

300 mg twice daily

Other names: Plant based polysaccharides

Primary outcomes

  1. Improvement of symptoms of metabolic syndrome

    Time frame: 8 weeks

Secondary outcomes

  1. Change in weight

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Yaounde 1

Other

Collaborators

  • Cameroon Nutritional Science Society

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2010
Registry last updated
Jan 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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