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
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Dietary Supplement: Theobromine
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects

Resource links provided by NLM:


Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Comparator: Single serving of theobromine Dietary Supplement: Theobromine
Single dose of theobromine
Active Comparator: Multiple servings of theobromine Dietary Supplement: Theobromine
Multiple doses of theobromine
Placebo Comparator: Placebo capsules Dietary Supplement: Placebo
Placebo capsules

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544829

Locations
France
Eurofins Optimed
Gieres, France
Sponsors and Collaborators
Unilever R&D
Investigators
Study Director: Wieneke Koppenol, MSc Unilever R&D
  More Information

No publications provided

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01544829     History of Changes
Other Study ID Numbers: FDS-SCC-0465
Study First Received: February 22, 2012
Last Updated: November 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Unilever R&D:
theobromine
heart rate
blood lipids

Additional relevant MeSH terms:
Cardiovascular Diseases
Theobromine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 14, 2014