NCT00611416

Brief Summary

The aim of this study is to elucidate the role of specific catechins, a mixture of catechins and caffeine in relation to weight control with particular emphasis on energy metabolism and fat oxidation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

First QC Date

August 21, 2007

Last Update Submit

February 6, 2009

Conditions

Obesity

Keywords

catechinscaffeineenergy expenditurefat oxidationappetite

Outcome Measures

Primary Outcomes (1)

  • fat oxidation

    november 2007

Secondary Outcomes (1)

  • appetite

    november 2007

Study Arms (5)

1

EXPERIMENTAL

Active treatment A

Dietary Supplement: green teaDietary Supplement: Mix of catechins and caffeine

2

EXPERIMENTAL

Active treatment B

Dietary Supplement: green teaDietary Supplement: EGCG

3

EXPERIMENTAL

Active treatment C

Dietary Supplement: green teaDietary Supplement: EGC

4

ACTIVE COMPARATOR

Positive control

Dietary Supplement: Caffeine

5

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

green teaDIETARY_SUPPLEMENT

different catechin combinations

123
Mix of catechins and caffeineDIETARY_SUPPLEMENT

3 tablet a day

1
EGCGDIETARY_SUPPLEMENT

3 tablets a day

Also known as: epigallocatechin gallate
2
EGCDIETARY_SUPPLEMENT

3 tablets a day

Also known as: Epigallocatechin
3
CaffeineDIETARY_SUPPLEMENT

3 tablets a day

4
PlaceboDIETARY_SUPPLEMENT

3 tablets a day

5

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men
  • Age 18-40 years
  • BMI 18,5-25 kg/m2

You may not qualify if:

  • Diabetes or any other endocrinological disease
  • Hypertensive medication
  • Increased Blood Pressure \> 140/85
  • Hyperlpidimia
  • Chronic disease (i.e. HIV)
  • Use of any diet supplements including vitamins (during and 3 months prior to the study).
  • High alcohol intake (\>21 units a week)
  • High caffeine intake (\>250 mg/day) or high catechin intake (\>200 mg/day)
  • Smoking
  • Elite sports performer
  • Use of any regular medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition, The Royal Veterinary and Agricultrual University

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

TeaCaffeineepigallocatechin gallategallocatechol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Arne Astrup, Proffessor

    Insitute of Human Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2007

First Posted

February 8, 2008

Study Start

November 1, 2005

Study Completion

February 1, 2006

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

DK(1)