NCT00302276

Brief Summary

The objective of the present study was to investigate the acute and sub-chronic effect of a supplement containing green tea extract, capsaisin, caffeine, tyrosine and calcium or placebo taken t.i.d on thermogenesis, body fat loss, and fecal fat excretion. Furthermore, if a 8-week supplementation could prevent weight-regain after initial 4-week weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_2 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
Last Updated

January 21, 2009

Status Verified

November 1, 2004

First QC Date

March 13, 2006

Last Update Submit

January 20, 2009

Conditions

Obesity

Keywords

Body fat lossenergy expenditurecapsaicincaffeinegreen teacalciumfecal fatfecal energy

Outcome Measures

Primary Outcomes (1)

  • Body weight, fat mass, fat free mass, energy expenditure, respiratory quotient, fecal fat, fecal energy

Secondary Outcomes (1)

  • blood pressure, heart rate, urine catecholamines, self-reported adverse events

Interventions

Metobes-compoundDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • smokers, athletic, daily use of medication except for anticonception and antihypertensive compounds, blood pressure above 165/95 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jens Kondrup, Prof

    Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 14, 2006

Study Start

January 1, 2004

Study Completion

July 1, 2004

Last Updated

January 21, 2009

Record last verified: 2004-11

Locations

DK(1)