NCT01288547

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

1 month

First QC Date

January 31, 2011

Last Update Submit

February 22, 2012

Conditions

Mood

Keywords

cognitionattentionmethylxanthine

Outcome Measures

Primary Outcomes (1)

  • Mood and cognition

    Bond Lader Visual Analogue Scale Digit Symbol Substitution Caffeine Negative Symptoms

    3 hrs every week for 4 weeks

Secondary Outcomes (1)

  • blood pressure and heart rate

    3 hrs every week for 4 weeks

Study Arms (4)

theobromine

ACTIVE COMPARATOR

theobromine (700 mg) in capsule

Dietary Supplement: theobromine

caffeine

ACTIVE COMPARATOR

caffeine (120 mg) in capsule

Dietary Supplement: Caffeine

Placebo capsule

PLACEBO COMPARATOR

no theobromine or caffeine

Dietary Supplement: placebo

theobromine + caffeine

ACTIVE COMPARATOR

Combined theobromine and caffeine treatment, consisting of 700 mg theobromine and 120 mg caffeine

Dietary Supplement: caffeine + theobromine

Interventions

theobromineDIETARY_SUPPLEMENT

700 mg theobromine in gelatin capsules given one time only

Also known as: 3,7-dimethylxanthine
theobromine
CaffeineDIETARY_SUPPLEMENT

120 mg caffeine in capsules given one time only

Also known as: 1,3,7-trimethylxanthine
caffeine
caffeine + theobromineDIETARY_SUPPLEMENT

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

Also known as: methylxanthines
theobromine + caffeine
placeboDIETARY_SUPPLEMENT

cellulose in capsules given one time only

Also known as: avicel (cellulose)
Placebo capsule

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unilever Discover

Vlaardingen, South Holland, 3130 AC, Netherlands

Location

MeSH Terms

Interventions

TheobromineCaffeinemethylxanthineCellulose

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Yvonne Zebregs

    Unilever R&D

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 2, 2011

Study Start

May 1, 2008

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations

NL(1)