NCT00302263

Brief Summary

To investigate the 5-hour acute effect on energy expenditure, substrate oxidation and ad libitum food intake after intake of the Metobes-compound (green tea extract, capsaicin, tyrosine, caffeine). Furthermore, to investigate if the effect of the Metobes-compound can be inhibited by blocking the β-adrenergic receptors. The effect of the Metobes-compound will be investigated by:

  1. 1.5-hour energy expenditure and respiratory quotient (ventilated hood).
  2. 2.5-h change in blood pressure and heart rate
  3. 3.5-h change in sympathetic/parasympathetic ratio.
  4. 4.Ad libitum energy intake.
  5. 5.Self-reported postprandiel appetite sensations (VAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Jan 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
12 months 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

March 14, 2006

Status Verified

August 1, 2005

First QC Date

March 13, 2006

Last Update Submit

March 13, 2006

Conditions

Obesity

Keywords

Green teacapsaicintyrosinecaffeineenergy expenditurecatecholamines

Outcome Measures

Primary Outcomes (6)

  • Energy expenditure

  • substrate oxidation

  • catecholmamines

  • energy intake

  • subjective appetite sensations

  • sympathetic/parasympathetic ratio

Interventions

Metobes-compoundDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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, PhD

    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
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 14, 2006

Study Start

January 1, 2005

Study Completion

April 1, 2005

Last Updated

March 14, 2006

Record last verified: 2005-08

Locations

DK(1)