NCT01481389

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 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

December 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

1 month

First QC Date

November 22, 2011

Last Update Submit

September 17, 2012

Conditions

Cardiovascular Diseases

Keywords

Blood lipidsrisk factor for cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

  • Blood lipids

    after 4 weeks intervention

Secondary Outcomes (2)

  • Blood pressure

    After 4 weeks intervention

  • Heart rate

    After 4 weeks intervention

Study Arms (4)

Theobromine drink

ACTIVE COMPARATOR
Dietary Supplement: Theobromine

Cocoa drink

ACTIVE COMPARATOR
Dietary Supplement: Cocoa

Placebo drink

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Cocoa and theobromine drink

ACTIVE COMPARATOR
Dietary Supplement: Cocoa and theobromine

Interventions

TheobromineDIETARY_SUPPLEMENT

200 ml drink with added theobromine (no cocoa added)

Theobromine drink
CocoaDIETARY_SUPPLEMENT

200 ml drink with cocoa (no theobromine added)

Cocoa drink
Cocoa and theobromineDIETARY_SUPPLEMENT

200 ml drink with added cocoa and theobromine

Cocoa and theobromine drink
PlaceboDIETARY_SUPPLEMENT

200 ml drink (no added theobromine or cocoa)

Placebo drink

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)
  • Willing and able to participate in the study protocol
  • Written informed consent
  • Age 40-70 years
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

Location

Related Publications (1)

  • Neufingerl N, Zebregs YE, Schuring EA, Trautwein EA. Effect of cocoa and theobromine consumption on serum HDL-cholesterol concentrations: a randomized controlled trial. Am J Clin Nutr. 2013 Jun;97(6):1201-9. doi: 10.3945/ajcn.112.047373. Epub 2013 Apr 17.

    PMID: 23595874DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

TheobromineChocolate

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Wieneke Koppenol, MSc

    Unilever R&D

    STUDY DIRECTOR

  • Nicole Neufingerl, 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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 29, 2011

Study Start

December 1, 2010

Primary Completion

January 1, 2011

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

FR(1)