Effects of Theobromine and Caffeine on Mood, Cognition and Blood Pressure

February 22, 2012 updated by: Unilever R&D

Temporal Change of Mood and Cognition in Healthy Subjects After Consumption of Theobromine and/ or Caffeine

The purpose of this study was to measure potential mood, cognition and blood pressure effects of theobromine and caffeine in healthy women

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Previous research has shown that naturally occurring chocolate ingredients theobromine and caffeine have positive effects on mood.

Objectives: To assess mood and cognition in adult subjects after the consumption of capsules filled with 1. placebo, 2. theobromine alone, 3. caffeine alone or, 4. theobromine and caffeine combined together.

Study design: Double-blind, placebo-controlled, randomized, cross-over design, with a 1 week washout period in between.

During the 4 weeks intervention period, once a week one of the 4 types of test products were consumed with 250ml of water in a randomized order;

  1. placebo capsules
  2. theobromine capsules (700 mg),
  3. caffeine capsules (120 mg),
  4. mix of theobromine (700 mg) and caffeine (120 mg). Twenty-four healthy female subjects (and 4 reserve subjects) were recruited for a four week intervention period in total with every week a 4 hrs measurement day and one of the interventions.

Primary parameters: mood (via a Bond-Lader/ caffeine visual analogue questionnaire), cognition (Digit Symbol substitution) Secondary parameters: blood pressure

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • Vlaardingen, Zuid Holland, Netherlands, 3130 AC
        • Unilever Discover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Age at start of study 18 till 70 years
  • Body Mass Index (BMI) between 20 and 30 kg/m2 inclusive
  • Reported alcohol consumption for females < 21
  • Willing to refrain from caffeine and theobromine for 24 hours
  • Apparently healthy: no reported current or previous metabolic diseases, chronic gastrointestinal disorders, cardiovascular or psychiatric disease which might effect study measurements assessed by Research physician
  • willing to consume animal foods products (gelatine).
  • Consumes caffeine (7 cups of either tea, cola or coffee per week minimum)
  • Having a general practitioner (GP)

Exclusion Criteria:

  • Being an Unilever employee
  • Blood pressure above 160/90 mmHg at screening and irregular heart rate
  • Using or planning to use any medically prescribed diet or weight-loss diet
  • Reported intense sporting activities > 10 h/w
  • Subjects who undergoing medical treatment that may interfere with the study outcome.
  • Reported weight change ± 10% during a period of 6 months prior to the study
  • Reported intolerance or allergy for one of test products or standardized meal
  • The habit of smoking during the past half year, drug use during the past half year or using nicotine containing medicines during the past month
  • Reported lactating (or lactating < 6 weeks ago), pregnant (or pregnant < 3 months ago) or wish to become pregnant during the study
  • Not able to perform the computer tasks assessed during screening
  • Reported participation in night shift work during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: theobromine
theobromine (700 mg) in capsule
Dietary supplement: theobromine
700 mg theobromine in gelatin capsules given one time only
Other Names:
  • 3,7-dimethylxanthine
Active Comparator: caffeine
caffeine (120 mg) in capsule
Dietary supplement: Caffeine
120 mg caffeine in capsules given one time only
Other Names:
  • 1,3,7-trimethylxanthine
Placebo Comparator: Placebo capsule
no theobromine or caffeine
Dietary supplement: placebo
cellulose in capsules given one time only
Other Names:
  • avicel (cellulose)
Active Comparator: theobromine + caffeine
Combined theobromine and caffeine treatment, consisting of 700 mg theobromine and 120 mg caffeine
Dietary supplement: caffeine + theobromine
120 mg caffeine and 700 mg theobromine in capsules given one time only
Other Names:
  • methylxanthines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood and cognition
Time Frame: 3 hrs every week for 4 weeks

Bond Lader Visual Analogue Scale

Digit Symbol Substitution

Caffeine Negative Symptoms
3 hrs every week for 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure and heart rate
Time Frame: 3 hrs every week for 4 weeks
3 hrs every week for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Investigators

  • Principal Investigator: Yvonne Zebregs, Unilever R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07045V

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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