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The Role of Tea Catechins and Caffeine in Relation to Energy Metabolism

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ClinicalTrials.gov Identifier: NCT00611416
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : February 9, 2009
Sponsor:
Collaborator:
Unilever R&D
Information provided by:
University of Copenhagen

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: green tea Dietary Supplement: Mix of catechins and caffeine Dietary Supplement: EGCG Dietary Supplement: EGC Dietary Supplement: Caffeine Dietary Supplement: Placebo Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Tea Catechins and Caffeine in Relation to Energy Metabolism in Man
Study Start Date : November 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
Drug Information available for: Cianidanol
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1
Active treatment A
 Dietary Supplement: green tea
different catechin combinations
Dietary Supplement: Mix of catechins and caffeine
3 tablet a day
Experimental: 2
Active treatment B
 Dietary Supplement: green tea
different catechin combinations
Dietary Supplement: EGCG
3 tablets a day
Other Name: epigallocatechin gallate
Experimental: 3
Active treatment C
 Dietary Supplement: green tea
different catechin combinations
Dietary Supplement: EGC
3 tablets a day
Other Name: Epigallocatechin
Active Comparator: 4
Positive control
 Dietary Supplement: Caffeine
3 tablets a day
Placebo Comparator: 5
Placebo
 Dietary Supplement: Placebo
3 tablets a day


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. fat oxidation [ Time Frame: november 2007 ]

Secondary Outcome Measures :
  1. appetite [ Time Frame: november 2007 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611416


Locations
Denmark
Institute of Human Nutrition, The Royal Veterinary and Agricultrual University
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Unilever R&D
Investigators
Study Chair: Arne Astrup, Proffessor Insitute of Human Nutrition
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00611416     History of Changes
Other Study ID Numbers: (KF) 01 279421
Unilever
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: February 2009

Keywords provided by University of Copenhagen:
catechins
caffeine
energy expenditure
fat oxidation
appetite

Additional relevant MeSH terms:
Caffeine
Epigallocatechin gallate
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
 Purinergic Agents
Neurotransmitter Agents
Antioxidants
Protective Agents
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents