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

NCT01544829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-12-03

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Theobromine

Single dose of theobromine

DIETARY_SUPPLEMENT

Theobromine

Multiple doses of theobromine

DIETARY_SUPPLEMENT

Placebo

Placebo capsules

Sponsors & Collaborators

  • Unilever R&D

    lead INDUSTRY

Principal Investigators

  • Wieneke Koppenol, MSc · Unilever R&D

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-04-30
Completion
2012-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544829 on ClinicalTrials.gov