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

Mood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288547
• Other study ID #: 07045V
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: February 22, 2012
• Start date: May 2008
• Est. completion date: July 2008

Study information

• Verified date: February 2012
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mood

Intervention

Dietary Supplement:
• theobromine
700 mg theobromine in gelatin capsules given one time only
• Caffeine
120 mg caffeine in capsules given one time only
• caffeine + theobromine
120 mg caffeine and 700 mg theobromine in capsules given one time only
• placebo
cellulose in capsules given one time only

Locations

Country	Name	City	State
Netherlands	Unilever Discover	Vlaardingen	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mood and cognition	Bond Lader Visual Analogue Scale; Digit Symbol Substitution; Caffeine Negative Symptoms	3 hrs every week for 4 weeks	No
Secondary	blood pressure and heart rate		3 hrs every week for 4 weeks	No