The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Theobromine; Dietary Supplement: Cocoa; Dietary Supplement: Placebo; Dietary Supplement: Cocoa and theobromine

• Registration Number: NCT01481389
• Lead Sponsor: Unilever R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-01
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-17
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Theobromine drink	Theobromine	-
Cocoa drink	Cocoa	-
Placebo drink	Placebo	-
Cocoa and theobromine drink	Cocoa and theobromine	-

Primary Outcome Measures

Name	Time	Method
Blood lipids	after 4 weeks intervention

Secondary Outcome Measures

Name	Time	Method
Blood pressure	After 4 weeks intervention
Heart rate	After 4 weeks intervention

Trial Locations

Locations (1)

Eurofins Optimed; 🇫🇷 Gieres, France