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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014