Skip to main content
OpenTrials
Completed

NCT Number: NCT01288547

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unilever Discover

Vlaardingen, South Holland, 3130 AC, Netherlands

About this study

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;

  • placebo capsules
  • theobromine capsules (700 mg),
  • caffeine capsules (120 mg),
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

theobromine

Dietary Supplement

700 mg theobromine in gelatin capsules given one time only

Other names: 3,7-dimethylxanthine

Caffeine

Dietary Supplement

120 mg caffeine in capsules given one time only

Other names: 1,3,7-trimethylxanthine

caffeine + theobromine

Dietary Supplement

120 mg caffeine and 700 mg theobromine in capsules given one time only

Other names: methylxanthines

Placebo

Dietary Supplement

cellulose in capsules given one time only

Other names: avicel (cellulose)

Primary outcomes

  1. Mood and cognition

    Time frame: 3 hrs every week for 4 weeks

    Bond Lader Visual Analogue Scale

    Digit Symbol Substitution

    Caffeine Negative Symptoms

Secondary outcomes

  1. blood pressure and heart rate

    Time frame: 3 hrs every week for 4 weeks

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 2, 2011
Registry last updated
Feb 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.