ObesityNCT00611416
The Role of Tea Catechins and Caffeine in Relation to Energy Metabolism
A study testing green tea, Mix of catechins and caffeine and EGCG in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- green tea, Mix of catechins and caffeine and EGCG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- Age 18-40 years
- BMI 18,5-25 kg/m2
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Human Nutrition, The Royal Veterinary and Agricultrual University
Frederiksberg C, 1958
About this study
Official title: The Role of Tea Catechins and Caffeine in Relation to Energy Metabolism in Man
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.
Read the detailed description
Obesity is the result of an imbalance between energy intake (EI) and energy expenditure (EE). Thus, two ways to treat obesity are to reduce EI or increase EE. Bioactive food ingredients affecting energy metabolism, e.g. EE, fat oxidation, satiety and EI may help people to successfully control or manage their weight. Green tea, one of the most widely consumed beverages in the world, may possess beneficial effects on the treatment of obesity.
Green tea is made from the leaves of Camellia sinensis species of the Theaceae family. Green tea is the non- fermented/oxidised products, in contrast to black tea that is fully fermented/oxidised. Green teas contain high quantities of catechins and caffeine which are believed to be the active components affecting energy metabolism. EGCG is the most abundant catechin and has received the most attention (Yang et al., 2000). Caffeine represents approximately 3 to 5 % of the dry weight of green tea (Dufresne et al., 2001, Yang et al., 2000). It is general accepted that caffeine consumption is related to an increase in EE (Astrup et al., 1990), whereas the relation between catechins and energy metabolism is recently discovered.
In a study by Dulloo et al (1999), ten healthy men were assigned to 3 treatments: 1) green tea extract containing 150 mg/day caffeine and 270 mg/day of EGCG, 2) caffeine (150 mg/day) or 3) placebo. Ingestion of green tea extract (taken with each meal) increased 24-h EE by 4 % (328 kJ), reflecting its stimulatory effect on thermogenesis. This study also found a reduction in the respiratory quotient (RQ) during the green tea extract treatment, suggesting an increase in fat oxidation. However, Kovacs et al. (2004) did not report any changes in 24-h EE or RQ after same supplementation with green tea capsules, which may be explained by different background caffeine consumption.
Recently, two medium term studies have reported of increased fat oxidation after 8 and 12 weeks, respectively, supplementation with tea catechin containing beverage (Ota et al., 2005, Harada et al., 2005). In addition, Nagao et al. (2005) have shown that a daily consumption of tea beverage containing 690 mg/day catechins for 12 weeks reduced body fat area by 8% compared to the control group. Thus, catechins may not only promote EE, but also mildly reduce body fat.
Several potential mechanisms responsible for the altered energy and fat metabolism have been proposed. Dulloo et al. (1999) have suggested a synergistic interaction between catechins and caffeine due to sympathetically released noradrenaline (NA). Since catechins are known to be capable of inhibiting catechol O-methyltransferase (COMT) (the enzyme that degrades NA) (Borchardt \& Huber, 1975), and caffeine to inhibit trancellular phosphodiesterases (enzymes that break down NA-induced cAMP), it is proposed that the green tea extract, via its catechins polyphenols and caffeine, is effective in stimulating thermogenesis by relieving inhibition at different control points along the NA-cAMP axis. Taken together, both caffeine and tea catechins would be expected to increase and/or prolong the stimulatory effects of norepinephrine on energy and lipid metabolism.
Several animal studies have been conducted to elucidate the anti-obese mechanisms of green tea extracts.
- Increased hepatic β-oxidation of fatty acids in mice after 4 weeks high fat diet with supplementation with tea catechins (74% EGCg, 18% ECg, 6% GCg, 2% others) (Murase et al., 2002 and 4 weeks high fat diet with supplementation with EGCg (Klaus et al., 2005). On the other hand, fatty acid synthase (FAS) was not altered by tea catechins, which may indicate that the simulation of fatty acid oxidation, rather than suppression of lipogenesis, is the predominant contribution (Murase et al., 2002).
- Modulated appetite and reduces food intake through the leptin receptor-independent pathway (Kao et al., 2000)
- Intraperitoneal administration of EGCg may reduce the diet digestibility resulting in increased faecal excretion of lipids (Klaus et al., 2005)
- Green tea extract (8% caffeine and 25% catechins (~70% EGCg)) stimulates brown adipose tissue thermogenesis and energy expenditure, which may be due to the prolonged effect of noradrenalin (Dulloo et al., 2000).
Large variations in catechin content and chemical structures occur during preparation and manufacturing of green tea products and therefore also among the studies. EGCg is the most intensely studied catechin. However, the plasma bioavailability of EGCg is lower than of EGC and EG (Henning et al., 2004), suggesting that non-galloylated catechins are better absorbed than the galloylated (Manach et al., 2005).
In addition, it is not known whether epimerization of catechins alters the effect on energy and fat metabolism (Harada et al., 2005, Ota et al., 2005, Xu et al., 2004). Therefore, it is not clear whether the reported effects are due to the total quantity of catechins, the chemical structure of specific catechins (e.g. epimerization and galloylation), and/or the caffeine content or other components of in the mix.
Methods
The study is a 5-way crossover double blind placebo controlled design. At each test day, energy expenditure and fat oxidation are measured via indirect calorimetry for 13 hours in one of two whole body respiratory chambers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green teaDietary supplement
different catechin combinations
Mix of catechins and caffeineDietary supplement
3 tablet a day
EGCGDietary supplement
Also called epigallocatechin gallate
3 tablets a day
EGCDietary supplement
Also called Epigallocatechin
3 tablets a day
CaffeineDietary supplement
3 tablets a day
PlaceboDietary supplement
3 tablets a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active treatment A Receives: Dietary Supplement: green tea; Dietary Supplement: Mix of catechins and caffeine |
| 2 | Experimental | Active treatment B Receives: Dietary Supplement: green tea; Dietary Supplement: EGCG |
| 3 | Experimental | Active treatment C Receives: Dietary Supplement: green tea; Dietary Supplement: EGC |
| 4 | Active comparator | Positive control Receives: Dietary Supplement: Caffeine |
| 5 | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fat oxidation
Measured: november 2007
Secondary outcomes (1)
appetite
Measured: november 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startNov 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Investigators
- Arne Astrup, Proffessor, Study chair, Insitute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611416
- Sponsor's protocol ID
- (KF) 01 279421
- Other IDs
- Unilever
- Status last verified
- Feb 2009
- First submitted
- 21 Aug 2007
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Tea Catechins and Caffeine in Relation to Energy Metabolism in Man
- ClinicalTrials.gov ID
- NCT00611416
- Acronym / sponsor ID
- (KF) 01 279421
- Conditions
- Obesity
- Keywords
- catechins, caffeine, energy expenditure, fat oxidation, appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Nov 2005
- Study completion
- Feb 2006 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is the result of an imbalance between energy intake (EI) and energy expenditure (EE). Thus, two ways to treat obesity are to reduce EI or increase EE. Bioactive food ingredients affecting energy metabolism, e.g. EE, fat oxidation, satiety and EI may help people to successfully control or manage their weight. Green tea, one of the most widely consumed beverages in the world, may possess beneficial effects on the treatment of obesity.
Green tea is made from the leaves of Camellia sinensis species of the Theaceae family. Green tea is the non- fermented/oxidised products, in contrast to black tea that is fully fermented/oxidised. Green teas contain high quantities of catechins and caffeine which are believed to be the active components affecting energy metabolism. EGCG is the most abundant catechin and has received the most attention (Yang et al., 2000). Caffeine represents approximately 3 to 5 % of the dry weight of green tea (Dufresne et al., 2001, Yang et al., 2000). It is general accepted that caffeine consumption is related to an increase in EE (Astrup et al., 1990), whereas the relation between catechins and energy metabolism is recently discovered.
In a study by Dulloo et al (1999), ten healthy men were assigned to 3 treatments: 1) green tea extract containing 150 mg/day caffeine and 270 mg/day of EGCG, 2) caffeine (150 mg/day) or 3) placebo. Ingestion of green tea extract (taken with each meal) increased 24-h EE by 4 % (328 kJ), reflecting its stimulatory effect on thermogenesis. This study also found a reduction in the respiratory quotient (RQ) during the green tea extract treatment, suggesting an increase in fat oxidation. However, Kovacs et al. (2004) did not report any changes in 24-h EE or RQ after same supplementation with green tea capsules, which may be explained by different background caffeine consumption.
Recently, two medium term studies have reported of increased fat oxidation after 8 and 12 weeks, respectively, supplementation with tea catechin containing beverage (Ota et al., 2005, Harada et al., 2005). In addition, Nagao et al. (2005) have shown that a daily consumption of tea beverage containing 690 mg/day catechins for 12 weeks reduced body fat area by 8% compared to the control group. Thus, catechins may not only promote EE, but also mildly reduce body fat.
Several potential mechanisms responsible for the altered energy and fat metabolism have been proposed. Dulloo et al. (1999) have suggested a synergistic interaction between catechins and caffeine due to sympathetically released noradrenaline (NA). Since catechins are known to be capable of inhibiting catechol O-methyltransferase (COMT) (the enzyme that degrades NA) (Borchardt \& Huber, 1975), and caffeine to inhibit trancellular phosphodiesterases (enzymes that break down NA-induced cAMP), it is proposed that the green tea extract, via its catechins polyphenols and caffeine, is effective in stimulating thermogenesis by relieving inhibition at different control points along the NA-cAMP axis. Taken together, both caffeine and tea catechins would be expected to increase and/or prolong the stimulatory effects of norepinephrine on energy and lipid metabolism.
Several animal studies have been conducted to elucidate the anti-obese mechanisms of green tea extracts.
- Increased hepatic β-oxidation of fatty acids in mice after 4 weeks high fat diet with supplementation with tea catechins (74% EGCg, 18% ECg, 6% GCg, 2% others) (Murase et al., 2002 and 4 weeks high fat diet with supplementation with EGCg (Klaus et al., 2005). On the other hand, fatty acid synthase (FAS) was not altered by tea catechins, which may indicate that the simulation of fatty acid oxidation, rather than suppression of lipogenesis, is the predominant contribution (Murase et al., 2002).
- Modulated appetite and reduces food intake through the leptin receptor-independent pathway (Kao et al., 2000)
- Intraperitoneal administration of EGCg may reduce the diet digestibility resulting in increased faecal excretion of lipids (Klaus et al., 2005)
- Green tea extract (8% caffeine and 25% catechins (~70% EGCg)) stimulates brown adipose tissue thermogenesis and energy expenditure, which may be due to the prolonged effect of noradrenalin (Dulloo et al., 2000).
Large variations in catechin content and chemical structures occur during preparation and manufacturing of green tea products and therefore also among the studies. EGCg is the most intensely studied catechin. However, the plasma bioavailability of EGCg is lower than of EGC and EG (Henning et al., 2004), suggesting that non-galloylated catechins are better absorbed than the galloylated (Manach et al., 2005).
In addition, it is not known whether epimerization of catechins alters the effect on energy and fat metabolism (Harada et al., 2005, Ota et al., 2005, Xu et al., 2004). Therefore, it is not clear whether the reported effects are due to the total quantity of catechins, the chemical structure of specific catechins (e.g. epimerization and galloylation), and/or the caffeine content or other components of in the mix.
Methods
The study is a 5-way crossover double blind placebo controlled design. At each test day, energy expenditure and fat oxidation are measured via indirect calorimetry for 13 hours in one of two whole body respiratory chambers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: green tea, Dietary Supplement: Mix of catechins and caffeineActive treatment A |
| 2 | Experimental | Dietary Supplement: green tea, Dietary Supplement: EGCGActive treatment B |
| 3 | Experimental | Dietary Supplement: green tea, Dietary Supplement: EGCActive treatment C |
| 4 | Active comparator | Dietary Supplement: CaffeinePositive control |
| 5 | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men
- Age 18-40 years
- BMI 18,5-25 kg/m2
Key exclusion criteria (11 listed)
- Diabetes or any other endocrinological disease
- Hypertensive medication
- Increased Blood Pressure > 140/85
- Hyperlpidimia
- Chronic disease (i.e. HIV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| green teadifferent catechin combinations | Dietary supplement | 1, 2, 3 |
| Mix of catechins and caffeine3 tablet a day | Dietary supplement | 1 |
| EGCGAlso: epigallocatechin gallate3 tablets a day | Dietary supplement | 2 |
| EGCAlso: Epigallocatechin3 tablets a day | Dietary supplement | 3 |
| Caffeine3 tablets a day | Dietary supplement | 4 |
| Placebo3 tablets a day | Dietary supplement | 5 |
Primary outcome
fat oxidation
Time frame: november 2007
1 secondary outcome
appetite
Time frame: november 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Proffessor study chair
Insitute of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing green tea, Mix of catechins and caffeine and EGCG in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fat oxidation (time frame: november 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.