NCT01046968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1 obesity

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
Last Updated

January 12, 2010

Status Verified

July 1, 2009

Enrollment Period

3 months

First QC Date

January 11, 2010

Last Update Submit

January 11, 2010

Conditions

ObesityHyperlipidemiaHyperglycemia

Keywords

Obesitymetabolic syndromeC-reactive proteinLeptin

Outcome Measures

Primary Outcomes (1)

  • Improvement of symptoms of metabolic syndrome

    8 weeks

Secondary Outcomes (1)

  • Change in weight

    8 weeks

Study Arms (1)

Lepticore

EXPERIMENTAL
Dietary Supplement: Lepticore

Interventions

LepticoreDIETARY_SUPPLEMENT

300 mg twice daily

Also known as: Plant based polysaccharides
Lepticore

Eligibility Criteria

Age19 Years - 52 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Nutrition and Nutritional Biochemistry

Yaoundé, Centre Region, 8418, Cameroon

Location

MeSH Terms

Conditions

ObesityHyperlipidemiasHyperglycemiaMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesGlucose Metabolism DisordersInsulin ResistanceHyperinsulinism

Study Officials

  • Julius E Oben, PhD

    University of Yaounde 1

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

August 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 12, 2010

Record last verified: 2009-07

Locations

CA(1)