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

The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Theobromine; Dietary supplement: Theobromine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gieres, France
    • Eurofins Optimed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active Comparator: Single serving of theobromine	Dietary supplement: Theobromine; Single dose of theobromine; Dietary supplement: Theobromine; Multiple doses of theobromine
ACTIVE_COMPARATOR: Multiple servings of theobromine	Dietary supplement: Theobromine; Single dose of theobromine; Dietary supplement: Theobromine; Multiple doses of theobromine
PLACEBO_COMPARATOR: Placebo capsules	Dietary supplement: Placebo; Placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Unilever R&D

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: February 28, 2012
• First Posted (ESTIMATE): March 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: heart rate; theobromine; blood lipids
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Theobromine
• Other Study ID Numbers: FDS-SCC-0465