The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01544829
First received: February 22, 2012
Last updated: November 30, 2012
Last verified: November 2012

February 22, 2012
November 30, 2012
February 2012
April 2012   (final data collection date for primary outcome measure)
Heart rate [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods
Heart rate [ Time Frame: Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01544829 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods ] [ Designated as safety issue: Yes ]
  • Hematocrit [ Time Frame: Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods ] [ Designated as safety issue: No ]
  • Serum blood lipids [ Time Frame: Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Cardiovascular Diseases
  • Dietary Supplement: Theobromine
    Single dose of theobromine
  • Dietary Supplement: Theobromine
    Multiple doses of theobromine
  • Dietary Supplement: Placebo
    Placebo capsules
  • Active Comparator: Active Comparator: Single serving of theobromine
    Intervention: Dietary Supplement: Theobromine
  • Active Comparator: Multiple servings of theobromine
    Intervention: Dietary Supplement: Theobromine
  • Placebo Comparator: Placebo capsules
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01544829
FDS-SCC-0465
No
Unilever R&D
Unilever R&D
Not Provided
Study Director: Wieneke Koppenol, MSc Unilever R&D
Unilever R&D
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP