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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to measure potential mood, cognition and blood pressure effects of theobromine and caffeine in healthy women

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; 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

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

Conditions
-----------------
Mood

Intervention / Treatment
-----------------
* Dietary Supplement: theobromine
* Dietary Supplement: Caffeine
* Dietary Supplement: caffeine + theobromine
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood and cognition | Bond Lader Visual Analogue Scale Digit Symbol Substitution Caffeine Negative Symptoms | 3 hrs every week for 4 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition, attention, methylxanthine