NCT01544829

Brief Summary

The main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day. This study also aims to study the pharmacokinetics of theobromine after administration once per day versus administration 4 times per day. Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is given in 4 smaller doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable cardiovascular-diseases

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

February 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

2 months

First QC Date

February 22, 2012

Last Update Submit

November 30, 2012

Conditions

Cardiovascular Diseases

Keywords

theobromineheart rateblood lipids

Outcome Measures

Primary Outcomes (1)

  • Heart rate

    Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods

    3 days

Secondary Outcomes (4)

  • Blood pressure

    Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods

  • Hematocrit

    Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods

  • Serum blood lipids

    Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods

  • Serum glucose and insulin concentrations

    Measured on day 1 and 2 (at time points -5min, 3h, 5h, 10h and 24h) for 3 periods

Study Arms (3)

Active Comparator: Single serving of theobromine

ACTIVE COMPARATOR
Dietary Supplement: Theobromine

Multiple servings of theobromine

ACTIVE COMPARATOR
Dietary Supplement: Theobromine

Placebo capsules

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

TheobromineDIETARY_SUPPLEMENT

Single dose of theobromine

Active Comparator: Single serving of theobromine
PlaceboDIETARY_SUPPLEMENT

Placebo capsules

Placebo capsules

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
  • Age 40-70 years
  • BMI ≥ 18 and ≤ 30 kg/m2
  • Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged non clinically significant by research physician
  • Written informed consent

You may not qualify if:

  • Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
  • Diabetes mellitus
  • Reported weight loss or gain of 10% body weight or more during a period of 6 months prior to screening
  • Reported intense sporting activities \> 10 h/week
  • Use of over-the -counter prescribed medication which may interfere with study measurements, as judged by the physician
  • Use of antibiotics in the three months before screening or during the run-in period.
  • Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself
  • High caffeine consumption: reported consumption of more than 8 cups/cans of caffeine-containing drinks per day, i.e. coffee, black or green tea and cola (also cola light, diet \& zero) OR consumption of more than 1 energy drink per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurofins Optimed

Gières, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Theobromine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Wieneke Koppenol, MSc

    Unilever R&D

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 6, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

FR(1)