The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01481389
First received: November 22, 2011
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters.

Hypothesis: theobromine has a positive effect on blood lipid parameters.


Condition Intervention
Cardiovascular Diseases
Dietary Supplement: Theobromine
Dietary Supplement: Cocoa
Dietary Supplement: Cocoa and theobromine
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • Blood lipids [ Time Frame: after 4 weeks intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: After 4 weeks intervention ] [ Designated as safety issue: Yes ]
  • Heart rate [ Time Frame: After 4 weeks intervention ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: December 2010
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Theobromine drink Dietary Supplement: Theobromine
200 ml drink with added theobromine (no cocoa added)
Active Comparator: Cocoa drink Dietary Supplement: Cocoa
200 ml drink with cocoa (no theobromine added)
Placebo Comparator: Placebo drink Dietary Supplement: Placebo
200 ml drink (no added theobromine or cocoa)
Active Comparator: Cocoa and theobromine drink Dietary Supplement: Cocoa and theobromine
200 ml drink with added cocoa and theobromine

  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)
  • Willing and able to participate in the study protocol
  • Written informed consent
  • Age 40-70 years
  • 10-year risk of developing CHD <10%, based on data from the Framingham Heart Study
  • BMI > 18 and < 30 kg/m2
  • Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by research physician
  • Willing to comply with the dietary restrictions of the study.
  • Accessible veins on arm(s) as determined by examination at screening

Exclusion Criteria:

  • Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
  • Diabetes mellitus
  • Reported alcohol consumption > 14 units/week (female) or > 21 units/week (male)
  • Currently on a medically prescribed diet, or slimming diet
  • Reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination
  • Reported intense sporting activities > 10 h/w
  • Use of 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 study.
  • 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
  • Reported intolerance to test products or other food products provided during the study
  • Blood donation 1 month (males) or 2 months (females) prior to screening and during the study
  • Reported participation in another nutritional or biomedical trial 3 months before screening or during the study.
  • Extreme coffee consumption
  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: NCT01481389

Locations
France
Eurofins Optimed
Gieres, France, 38610
Sponsors and Collaborators
Unilever R&D
Investigators
Study Director: Wieneke Koppenol, MSc Unilever R&D
Study Director: Nicole Neufingerl, MSc Unilever R&D
  More Information

No publications provided by Unilever R&D

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01481389     History of Changes
Other Study ID Numbers: 10022V
Study First Received: November 22, 2011
Last Updated: September 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Unilever R&D:
Blood lipids
risk factor for cardiovascular diseases

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 September 18, 2014