NCT01308892

Brief Summary

In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 17, 2011

Status Verified

June 1, 2011

Enrollment Period

5 months

First QC Date

February 15, 2011

Last Update Submit

June 16, 2011

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (3)

  • Blood pressure

    0, 4wk

  • FMD

    0, 4wk

  • PWA

    0, 4wk

Secondary Outcomes (9)

  • leukocyte count and activation

    0, 4wk

  • PBMC gene expression

    0, 4wk

  • Markers of inflammation and ED

    0, 4wk

  • Blood pressure

    0 and 2h

  • FMD

    0 and 2hrs

  • +4 more secondary outcomes

Study Arms (2)

High flavaonol chocolate

ACTIVE COMPARATOR
Dietary Supplement: High flavanol chocolateDietary Supplement: High fat challenge

Low flavanol chocolate

PLACEBO COMPARATOR
Dietary Supplement: Low flavanol chocolateDietary Supplement: High fat challenge

Interventions

High flavanol chocolateDIETARY_SUPPLEMENT

chocolate high in flavanols

High flavaonol chocolate
Low flavanol chocolateDIETARY_SUPPLEMENT

chocolate low in flavanols

Low flavanol chocolate
High fat challengeDIETARY_SUPPLEMENT

Milkshake with 95g fat

High flavaonol chocolateLow flavanol chocolate

Eligibility Criteria

Age45 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • years old
  • BMI between 25 and 32 kg/m2

You may not qualify if:

  • Urine glucose concentrations outside normal ranges (\> 0,25 g/l)
  • Fasting blood glucose \< 7.0 mmol/L)
  • Systolic Bp \> 160 mmHg or diastolic Bp \> 100 mmHg
  • Blood Hb values below 8.4 mmol/L
  • Allergic to cow milk, dairy products or chocolate
  • Vegetarian
  • Tobacco smoker
  • Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen universiteit division of human

Wageningen, Gelderland, 6703HD, Netherlands

Location

Study Officials

  • Michael Müller, Prof.Dr

    Chair Department of human nutrition NMG group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2011

First Posted

March 4, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 17, 2011

Record last verified: 2011-06

Locations

NL(1)