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
  Purpose

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


Condition Intervention
Mood
Dietary Supplement: theobromine
Dietary Supplement: Caffeine
Dietary Supplement: caffeine + theobromine
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Temporal Change of Mood and Cognition in Healthy Subjects After Consumption of Theobromine and/ or Caffeine

Resource links provided by NLM:


Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • blood pressure and heart rate [ Time Frame: 3 hrs every week for 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2008
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: theobromine
theobromine (700 mg) in capsule
Dietary Supplement: theobromine
700 mg theobromine in gelatin capsules given one time only
Other Name: 3,7-dimethylxanthine
Active Comparator: caffeine
caffeine (120 mg) in capsule
Dietary Supplement: Caffeine
120 mg caffeine in capsules given one time only
Other Name: 1,3,7-trimethylxanthine
Placebo Comparator: Placebo capsule
no theobromine or caffeine
Dietary Supplement: placebo
cellulose in capsules given one time only
Other Name: 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 Name: methylxanthines

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288547

Locations
Netherlands
Unilever Discover
Vlaardingen, Zuid Holland, Netherlands, 3130 AC
Sponsors and Collaborators
Unilever R&D
Investigators
Principal Investigator: Yvonne Zebregs Unilever R&D
  More Information

No publications provided

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01288547     History of Changes
Other Study ID Numbers: 07045V
Study First Received: January 31, 2011
Last Updated: February 22, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Unilever R&D:
cognition
attention
methylxanthine

Additional relevant MeSH terms:
Caffeine
Theobromine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014