MoodNCT01288547
Effects of Theobromine and Caffeine on Mood, Cognition and Blood Pressure
A study testing theobromine, Caffeine and caffeine + theobromine in people with Mood, run by Unilever R&D at 1 site in Netherlands.
Trial summary
The purpose of this study was to measure potential mood, cognition and blood pressure effects of theobromine and caffeine in healthy women Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mood
- What is being tested?
- theobromine, Caffeine and caffeine + theobromine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2008to Jul 2008
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Age at start of study 18 till 70 years
- Body Mass Index (BMI) between 20 and 30 kg/m2 inclusive
- Reported alcohol consumption for females < 21
- Willing to refrain from caffeine and theobromine for 24 hours
- Apparently healthy: no reported current or previous metabolic diseases, chronic gastrointestinal disorders, cardiovascular or psychiatric disease which might effect study measurements assessed by Research physician
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- willing to consume animal foods products (gelatine).
- Consumes caffeine (7 cups of either tea, cola or coffee per week minimum)
- Having a general practitioner (GP)
Who cannot join
- Being an Unilever employee
- Blood pressure above 160/90 mmHg at screening and irregular heart rate
- Using or planning to use any medically prescribed diet or weight-loss diet
- Reported intense sporting activities > 10 h/w
- Subjects who undergoing medical treatment that may interfere with the study outcome.
- Reported weight change ± 10% during a period of 6 months prior to the study
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- Reported intolerance or allergy for one of test products or standardized meal
- The habit of smoking during the past half year, drug use during the past half year or using nicotine containing medicines during the past month
- Reported lactating (or lactating < 6 weeks ago), pregnant (or pregnant < 3 months ago) or wish to become pregnant during the study
- Not able to perform the computer tasks assessed during screening
- Reported participation in night shift work during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Change of Mood and Cognition in Healthy Subjects After Consumption of Theobromine and/ or Caffeine
The purpose of this study was to measure potential mood, cognition and blood pressure effects of theobromine and caffeine in healthy women
Read the detailed description
Background Previous research has shown that naturally occurring chocolate ingredients theobromine and caffeine have positive effects on mood.
Objectives: To assess mood and cognition in adult subjects after the consumption of capsules filled with 1. placebo, 2. theobromine alone, 3. caffeine alone or, 4. theobromine and caffeine combined together.
Study design: Double-blind, placebo-controlled, randomized, cross-over design, with a 1 week washout period in between.
During the 4 weeks intervention period, once a week one of the 4 types of test products were consumed with 250ml of water in a randomized order;
- placebo capsules
- theobromine capsules (700 mg),
- caffeine capsules (120 mg),
- mix of theobromine (700 mg) and caffeine (120 mg). Twenty-four healthy female subjects (and 4 reserve subjects) were recruited for a four week intervention period in total with every week a 4 hrs measurement day and one of the interventions.
Primary parameters: mood (via a Bond-Lader/ caffeine visual analogue questionnaire), cognition (Digit Symbol substitution) Secondary parameters: blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theobromineDietary supplement
Also called 3,7-dimethylxanthine
700 mg theobromine in gelatin capsules given one time only
CaffeineDietary supplement
Also called 1,3,7-trimethylxanthine
120 mg caffeine in capsules given one time only
caffeine + theobromineDietary supplement
Also called methylxanthines
120 mg caffeine and 700 mg theobromine in capsules given one time only
placeboDietary supplement
Also called avicel (cellulose)
cellulose in capsules given one time only
| Study group | Role | What they receive |
|---|---|---|
| theobromine | Active comparator | theobromine (700 mg) in capsule Receives: Dietary Supplement: theobromine |
| caffeine | Active comparator | caffeine (120 mg) in capsule Receives: Dietary Supplement: Caffeine |
| Placebo capsule | Placebo comparator | no theobromine or caffeine Receives: Dietary Supplement: placebo |
| theobromine + caffeine | Active comparator | Combined theobromine and caffeine treatment, consisting of 700 mg theobromine and 120 mg caffeine Receives: Dietary Supplement: caffeine + theobromine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood and cognition
Bond Lader Visual Analogue Scale
Digit Symbol Substitution
Caffeine Negative Symptoms
Measured: 3 hrs every week for 4 weeks
Secondary outcomes (1)
blood pressure and heart rate
Measured: 3 hrs every week for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvonne Zebregs, Principal investigator, Unilever R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288547
- Sponsor's protocol ID
- 07045V
- Status last verified
- Feb 2012
- First submitted
- 31 Jan 2011
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Change of Mood and Cognition in Healthy Subjects After Consumption of Theobromine and/ or Caffeine
- ClinicalTrials.gov ID
- NCT01288547
- Acronym / sponsor ID
- 07045V
- Conditions
- Mood
- Keywords
- cognition, attention, methylxanthine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Feb 2011 (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 purpose of this study was to measure potential mood, cognition and blood pressure effects of theobromine and caffeine in healthy women
Detailed description
Background Previous research has shown that naturally occurring chocolate ingredients theobromine and caffeine have positive effects on mood.
Objectives: To assess mood and cognition in adult subjects after the consumption of capsules filled with 1. placebo, 2. theobromine alone, 3. caffeine alone or, 4. theobromine and caffeine combined together.
Study design: Double-blind, placebo-controlled, randomized, cross-over design, with a 1 week washout period in between.
During the 4 weeks intervention period, once a week one of the 4 types of test products were consumed with 250ml of water in a randomized order;
- placebo capsules
- theobromine capsules (700 mg),
- caffeine capsules (120 mg),
- mix of theobromine (700 mg) and caffeine (120 mg). Twenty-four healthy female subjects (and 4 reserve subjects) were recruited for a four week intervention period in total with every week a 4 hrs measurement day and one of the interventions.
Primary parameters: mood (via a Bond-Lader/ caffeine visual analogue questionnaire), cognition (Digit Symbol substitution) Secondary parameters: blood pressure
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| theobromine | Active comparator | Dietary Supplement: theobrominetheobromine (700 mg) in capsule |
| caffeine | Active comparator | Dietary Supplement: Caffeinecaffeine (120 mg) in capsule |
| Placebo capsule | Placebo comparator | Dietary Supplement: placebono theobromine or caffeine |
| theobromine + caffeine | Active comparator | Dietary Supplement: caffeine + theobromineCombined theobromine and caffeine treatment, consisting of 700 mg theobromine and 120 mg caffeine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Age at start of study 18 till 70 years
- Body Mass Index (BMI) between 20 and 30 kg/m2 inclusive
- Reported alcohol consumption for females < 21
- Willing to refrain from caffeine and theobromine for 24 hours
Key exclusion criteria (11 listed)
- Being an Unilever employee
- Blood pressure above 160/90 mmHg at screening and irregular heart rate
- Using or planning to use any medically prescribed diet or weight-loss diet
- Reported intense sporting activities > 10 h/w
- Subjects who undergoing medical treatment that may interfere with the study outcome.
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 |
|---|---|---|
| theobromineAlso: 3,7-dimethylxanthine700 mg theobromine in gelatin capsules given one time only | Dietary supplement | theobromine |
| CaffeineAlso: 1,3,7-trimethylxanthine120 mg caffeine in capsules given one time only | Dietary supplement | caffeine |
| caffeine + theobromineAlso: methylxanthines120 mg caffeine and 700 mg theobromine in capsules given one time only | Dietary supplement | theobromine + caffeine |
| placeboAlso: avicel (cellulose)cellulose in capsules given one time only | Dietary supplement | Placebo capsule |
Primary outcome
Mood and cognition
Time frame: 3 hrs every week for 4 weeks
Bond Lader Visual Analogue Scale Digit Symbol Substitution Caffeine Negative Symptoms
1 secondary outcome
blood pressure and heart rate
Time frame: 3 hrs every week for 4 weeks
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 23 Feb 2012.
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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.
Yvonne Zebregs principal investigator
Unilever R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing theobromine, Caffeine and caffeine + theobromine in people with Mood, run by Unilever R&D at 1 site in Netherlands.
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 9 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 23 Feb 2012. 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 Netherlands. 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?
Mood and cognition (time frame: 3 hrs every week for 4 weeks). 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 23 Feb 2012.