Expired Study
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Davis, California 95616


Purpose:

Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study is a continuation of a previous study investigating the consumptions of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans


Criteria:

Inclusion Criteria: - 30-55 years old - A normal blood chemistry and liver function - BMI < 30 kg/m2 - previously consumed cocoa and peanut products, with no adverse reactions Exclusion Criteria: - A history of cardiovascular disease, stroke, hypertension, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet. - Allergies to nuts, cocoa and chocolate products - Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or using herbal dietary supplements


Study is Available At:


Original ID:

311497-II


NCT ID:

NCT02447783


Secondary ID:


Study Acronym:


Brief Title:

Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 2


Official Title:

Effect of Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 2


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

30 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Actual


Overall Contact Information

Official Name:Carl L Keen, PhD
Principal Investigator
UC Davis

Study Dates

Start Date:June 2012
Completion Date:December 2012
Completion Type:Actual
Primary Completion Date:December 2012
Primary Completion Type:Actual
Verification Date:February 2014
Last Changed Date:May 18, 2015
First Received Date:May 15, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in metabolic parameters in blood
Time Frame:Baseline (day 0) and 6, 12 and 14 weeks after intervention
Safety Issues:True
Description:Metabolic parameters determined in blood included: comprehensive metabolic panel, liver panel and cell blood counting.
Outcome Type:Secondary Outcome
Measure:Change in 24 h ambulatory blood pressure
Time Frame:Baseline (day 0) and 12 weeks after intervention
Safety Issues:True
Description:24 h ambulatory blood pressure will be measured using standard techniques.
Outcome Type:Secondary Outcome
Measure:Change in platelet function
Time Frame:Baseline and 6, 12 and 14 weeks after intervention
Safety Issues:True
Description:Platelet function will be determined using the PFA-100® analyzer (Dade Behring International, Miami, FL) with collagen-epinephrine (CEPI)- and collagen-ADP (CADP) stimulation.
Outcome Type:Primary Outcome
Measure:Change in blood pressure
Time Frame:Baseline (day 0) and 6,12 and 14 weeks after intervention
Safety Issues:True
Description:Blood pressure will be measured using standard techniques.

Study Interventions

Intervention Type:Dietary Supplement
Name:Control Capsules
Description:Cocoa-based, flavanol-free, control-matched capsules consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).
Arm Name:Control, Flavanol-free intervention
Intervention Type:Dietary Supplement
Name:Mars Cocoa Extract Capsules
Description:Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 500 mg of cocoa flavanols per capsule consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).
Arm Name:CF intervention

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Control, Flavanol-free intervention
Description:Intake of flavanol-free, macro- and micro-nutrient matched control capsules
Study Arm Type:Active Comparator
Arm Name:CF intervention
Description:Intake of capsules containing Mars Cocoa Extract Capsules manufactured by the Cocoapro® process and providing 500 mg of cocoa flavanols per capsule

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Carl L. Keen, PhD

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Schroeter H, Heiss C, Spencer JP, Keen CL, Lupton JR, Schmitz HH. Recommending flavanols and procyanidins for cardiovascular health: current knowledge and future needs. Mol Aspects Med. 2010 Dec;31(6):546-57. doi: 10.1016/j.mam.2010.09.008. Epub 2010 Sep 18. Review.
PMID:20854838

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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