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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544829
• Other study ID #: FDS-SCC-0465
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: November 30, 2012
• Start date: February 2012
• Est. completion date: June 2012

Study information

• Verified date: November 2012
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Theobromine
Single dose of theobromine
• Theobromine
Multiple doses of theobromine
• Placebo
Placebo capsules

Locations

Country	Name	City	State
France	Eurofins Optimed	Gieres

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods	3 days	Yes
Secondary	Blood pressure		Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods	Yes
Secondary	Hematocrit		Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods	No
Secondary	Serum blood lipids		Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods	No
Secondary	Serum glucose and insulin concentrations		Measured on day 1 and 2 (at time points -5min, 3h, 5h, 10h and 24h) for 3 periods	No