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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Theobromine; Dietary Supplement: Placebo

• Registration Number: NCT01544829
• Lead Sponsor: Unilever R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-03-06
• Primary Completion: 2012-04
• Study Completion: 2012-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Multiple servings of theobromine	Theobromine	-
Placebo capsules	Placebo	-
Active Comparator: Single serving of theobromine	Theobromine	-

Primary Outcome Measures

Name	Time	Method
Heart rate	3 days	Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods
Hematocrit	Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods
Serum blood lipids	Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods
Serum glucose and insulin concentrations	Measured on day 1 and 2 (at time points -5min, 3h, 5h, 10h and 24h) for 3 periods

Trial Locations

Locations (1)

Eurofins Optimed; 🇫🇷 Gieres, France