Cardiovascular DiseasesNCT01544829
The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects
A study testing Theobromine in people with Cardiovascular Diseases, run by Unilever R&D at 1 site in France.
Trial summary
The main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Theobromine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Jun 2012
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
- Age 40-70 years
- BMI ≥ 18 and ≤ 30 kg/m2
- Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged non clinically significant by research physician
- Written informed consent
Who cannot join
- Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
- Diabetes mellitus
- Reported weight loss or gain of 10% body weight or more during a period of 6 months prior to screening
- Reported intense sporting activities > 10 h/week
- Use of over-the -counter prescribed medication which may interfere with study measurements, as judged by the physician
- Use of antibiotics in the three months before screening or during the run-in period.
- Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself
- High caffeine consumption: reported consumption of more than 8 cups/cans of caffeine-containing drinks per day, i.e. coffee, black or green tea and cola (also cola light, diet \& zero) OR consumption of more than 1 energy drink per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects
The main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day.
This study also aims to study the pharmacokinetics of theobromine after administration once per day versus administration 4 times per day.
Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is given in 4 smaller doses.
- Conditions
- Cardiovascular Diseases
- Being tested
- Theobromine, Placebo
- Keywords
- theobromine, heart rate, blood lipids
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheobromineDietary supplement
Single dose of theobromine
TheobromineDietary supplement
Multiple doses of theobromine
PlaceboDietary supplement
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Single serving of theobromine | Active comparator | Not described Receives: Dietary Supplement: Theobromine |
| Multiple servings of theobromine | Active comparator | Not described Receives: Dietary Supplement: Theobromine |
| Placebo capsules | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods
Measured: 3 days
Secondary outcomes (4)
Blood pressure
Measured: Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods
Hematocrit
Measured: Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods
Serum blood lipids
Measured: Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods
Serum glucose and insulin concentrations
Measured: Measured on day 1 and 2 (at time points -5min, 3h, 5h, 10h and 24h) for 3 periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wieneke Koppenol, MSc, Study director, Unilever R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544829
- Sponsor's protocol ID
- FDS-SCC-0465
- Status last verified
- Nov 2012
- First submitted
- 22 Feb 2012
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects
- ClinicalTrials.gov ID
- NCT01544829
- Acronym / sponsor ID
- FDS-SCC-0465
- Conditions
- Cardiovascular Diseases
- Keywords
- theobromine, heart rate, blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Mar 2012 (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 main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day.
This study also aims to study the pharmacokinetics of theobromine after administration once per day versus administration 4 times per day.
Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is given in 4 smaller doses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Single serving of theobromine | Active comparator | Dietary Supplement: Theobromine |
| Multiple servings of theobromine | Active comparator | Dietary Supplement: Theobromine |
| Placebo capsules | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
- Age 40-70 years
- BMI ≥ 18 and ≤ 30 kg/m2
- Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged non clinically significant by research physician
- Written informed consent
Key exclusion criteria (8 listed)
- Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
- Diabetes mellitus
- Reported weight loss or gain of 10% body weight or more during a period of 6 months prior to screening
- Reported intense sporting activities > 10 h/week
- Use of over-the -counter prescribed medication which may interfere with study measurements, as judged by the physician
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 |
|---|---|---|
| TheobromineSingle dose of theobromine | Dietary supplement | Active Comparator: Single serving of theobromine |
| TheobromineMultiple doses of theobromine | Dietary supplement | Multiple servings of theobromine |
| PlaceboPlacebo capsules | Dietary supplement | Placebo capsules |
Primary outcome
Heart rate
Time frame: 3 days
Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods
4 secondary outcomes
Blood pressure
Time frame: Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods
Hematocrit
Time frame: Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods
Serum blood lipids
Time frame: Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods
Serum glucose and insulin concentrations
Time frame: Measured on day 1 and 2 (at time points -5min, 3h, 5h, 10h and 24h) for 3 periods
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 3 Dec 2012.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Wieneke Koppenol, MSc study director
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 in people with Cardiovascular Diseases, run by Unilever R&D at 1 site in France.
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 5 inclusion and 8 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 3 Dec 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 France. 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?
Heart rate (time frame: 3 days). 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 3 Dec 2012.