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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01288547
First received: January 31, 2011
Last updated: February 22, 2012
Last verified: February 2012

January 31, 2011
February 22, 2012
May 2008
June 2008   (final data collection date for primary outcome measure)
Mood and cognition [ Time Frame: 3 hrs every week for 4 weeks ] [ Designated as safety issue: No ]

Bond Lader Visual Analogue Scale

Digit Symbol Substitution

Caffeine Negative Symptoms

Same as current
Complete list of historical versions of study NCT01288547 on ClinicalTrials.gov Archive Site
blood pressure and heart rate [ Time Frame: 3 hrs every week for 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Theobromine and Caffeine on Mood, Cognition and Blood Pressure
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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Mood
  • Dietary Supplement: theobromine
    700 mg theobromine in gelatin capsules given one time only
    Other Name: 3,7-dimethylxanthine
  • Dietary Supplement: Caffeine
    120 mg caffeine in capsules given one time only
    Other Name: 1,3,7-trimethylxanthine
  • Dietary Supplement: caffeine + theobromine
    120 mg caffeine and 700 mg theobromine in capsules given one time only
    Other Name: methylxanthines
  • Dietary Supplement: placebo
    cellulose in capsules given one time only
    Other Name: avicel (cellulose)
  • Active Comparator: theobromine
    theobromine (700 mg) in capsule
    Intervention: Dietary Supplement: theobromine
  • Active Comparator: caffeine
    caffeine (120 mg) in capsule
    Intervention: Dietary Supplement: Caffeine
  • Placebo Comparator: Placebo capsule
    no theobromine or caffeine
    Intervention: Dietary Supplement: placebo
  • Active Comparator: theobromine + caffeine
    Combined theobromine and caffeine treatment, consisting of 700 mg theobromine and 120 mg caffeine
    Intervention: Dietary Supplement: caffeine + theobromine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2008
June 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01288547
07045V
No
Unilever R&D
Unilever R&D
Not Provided
Principal Investigator: Yvonne Zebregs Unilever R&D
Unilever R&D
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP