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Completed

NCT Number: NCT01481389

The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters.

Hypothesis: theobromine has a positive effect on blood lipid parameters.

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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, 38610, 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)
  • Willing and able to participate in the study protocol
  • Written informed consent
  • Age 40-70 years
  • 10-year risk of developing CHD <10%, based on data from the Framingham Heart Study
  • BMI > 18 and < 30 kg/m2
  • Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by research physician
  • Willing to comply with the dietary restrictions of the study.
  • Accessible veins on arm(s) as determined by examination at screening

Exclusion criteria

  • Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
  • Diabetes mellitus
  • Reported alcohol consumption > 14 units/week (female) or > 21 units/week (male)
  • Currently on a medically prescribed diet, or slimming diet
  • Reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination
  • Reported intense sporting activities > 10 h/w
  • Use of 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 study.
  • 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
  • Reported intolerance to test products or other food products provided during the study
  • Blood donation 1 month (males) or 2 months (females) prior to screening and during the study
  • Reported participation in another nutritional or biomedical trial 3 months before screening or during the study.
  • Extreme coffee consumption

Treatment and study plan

theobromine

Dietary Supplement

200 ml drink with added theobromine (no cocoa added)

cocoa

Dietary Supplement

200 ml drink with cocoa (no theobromine added)

Cocoa and theobromine

Dietary Supplement

200 ml drink with added cocoa and theobromine

Placebo

Dietary Supplement

200 ml drink (no added theobromine or cocoa)

Primary outcomes

  1. Blood lipids

    Time frame: after 4 weeks intervention

Secondary outcomes

  1. Blood pressure

    Time frame: After 4 weeks intervention

  2. Heart rate

    Time frame: After 4 weeks intervention

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
First posted
Nov 29, 2011
Registry last updated
Sep 18, 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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