NCT01710722

Brief Summary

The purpose of this study is to compare three treatments to see which causes the most weight loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2001

Shorter than P25 for not_applicable 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

February 1, 2001

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

October 17, 2012

Last Update Submit

December 17, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine.

    28 weeks

Secondary Outcomes (30)

  • Compare the loss of fat and lean tissue with leptin alone.

    28 Weeks

  • To compare the loss of fat and lean tissue with caffeine with ephedrine alone.

    28 Weeks

  • compare the loss of fat and lean tissue with leptin, ephedrine and caffeine combination.

    28 Weeks

  • To compare weight loss with leptin alone.

    28 Weeks

  • To compare weight loss caffeine with ephedrine alone.

    28 Weeks

  • +25 more secondary outcomes

Study Arms (3)

caffeine and ephedrine

EXPERIMENTAL

Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.

Drug: caffeine and ephedrine

leptin A

EXPERIMENTAL

Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.

Drug: Leptin A

caffeine, ephedrine, and leptin A

EXPERIMENTAL

Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.

Drug: caffeine, ephedrine, and leptin A

Interventions

caffeine and ephedrineDRUG

Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.

caffeine and ephedrine
Leptin ADRUG

Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.

leptin A
caffeine, ephedrine, and leptin ADRUG

Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.

caffeine, ephedrine, and leptin A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • You are healthy.
  • You are not pregnant or nursing.
  • You are between 18 and 60 years of age.
  • You have a body mass index, calculated from your height and weight, of 30 to 40 kg/m2.

You may not qualify if:

  • You take chronic medications except hormone replacement or contraception.
  • You are a woman and are unwilling to use effective contraception during the trial.
  • You have blood pressure higher than 150/90.
  • You have heart disease.
  • You have urinary symptoms from an enlarged prostate.
  • You have gained or lost more than 10 pounds in the last 6 months.
  • You have used a monoamine oxidase inhibitor medication in the last month.
  • You have high or low thyroid function that has not been controlled in the normal range for at least 2 months.
  • You have heart disease or a history of stroke.
  • You have a known sensitivity to E. coli or E. coli derived products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Liu AG, Smith SR, Fujioka K, Greenway FL. The effect of leptin, caffeine/ephedrine, and their combination upon visceral fat mass and weight loss. Obesity (Silver Spring). 2013 Oct;21(10):1991-6. doi: 10.1002/oby.20416. Epub 2013 Jun 11.

    PMID: 23686786DERIVED

MeSH Terms

Conditions

Obesity

Interventions

caffeine, ephedrine drug combinationlepa protein, zebrafishCaffeineEphedrine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 19, 2012

Study Start

February 1, 2001

Primary Completion

February 1, 2002

Study Completion

February 1, 2002

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(1)