The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

Unilever

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cocoa; Dietary Supplement: Cocoa and theobromine; Dietary Supplement: Theobromine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01481389

10022V

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 4 patient groups, including a placebo group

Theobromine drink

Active Comparator group

Treatment:

Dietary Supplement: Theobromine

Cocoa drink

Active Comparator group

Treatment:

Dietary Supplement: Cocoa

Placebo drink

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Cocoa and theobromine drink

Active Comparator group

Treatment:

Dietary Supplement: Cocoa and theobromine