The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

Cardiovascular Diseases Clinical Trial

Official title:

The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481389
• Other study ID #: 10022V
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: September 17, 2012
• Start date: December 2010

Study information

• Verified date: September 2012
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Theobromine
200 ml drink with added theobromine (no cocoa added)
• Cocoa
200 ml drink with cocoa (no theobromine added)
• Cocoa and theobromine
200 ml drink with added cocoa and theobromine
• Placebo
200 ml drink (no added theobromine or cocoa)

Locations

Country	Name	City	State
France	Eurofins Optimed	Gieres

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lipids		after 4 weeks intervention	No
Secondary	Blood pressure		After 4 weeks intervention	Yes
Secondary	Heart rate		After 4 weeks intervention	Yes