The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects

Unilever

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Theobromine; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01544829

FDS-SCC-0465

Details and patient eligibility

About

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.

Enrollment: 12 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)
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 3 patient groups, including a placebo group

Active Comparator: Single serving of theobromine

Active Comparator group

Treatment:

Dietary Supplement: Theobromine

Dietary Supplement: Theobromine

Multiple servings of theobromine

Active Comparator group

Treatment:

Dietary Supplement: Theobromine

Dietary Supplement: Theobromine

Placebo capsules

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo