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OpenTrials
Completed

NCT Number: NCT01544829

The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins Optimed

Gières, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

theobromine

Dietary Supplement

Single dose of theobromine

Placebo

Dietary Supplement

Placebo capsules

Primary outcomes

  1. Heart rate

    Time frame: 3 days

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

Secondary outcomes

  1. Blood pressure

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

  2. Hematocrit

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

  3. Serum blood lipids

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

  4. Serum glucose and insulin concentrations

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

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 6, 2012
Registry last updated
Dec 3, 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.

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