Sex-dependent Effects of Flavanols on Vascular Status

• Sponsor: Heinrich-Heine University, Duesseldorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT02147223
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Duration (Months): 12
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Dietary Supplement: Flavanol rich intervention; Dietary Supplement: Flavanol free intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Flavanol rich product A 250 mg flavanols	Dietary Supplement: Flavanol rich intervention; Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols); Dietary Supplement: Flavanol free intervention; Calorically, micro- and macronutrient matched control product free of flavanols
Active Comparator: Flavanol rich product B 500 mg flavanols	Dietary Supplement: Flavanol rich intervention; Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols); Dietary Supplement: Flavanol free intervention; Calorically, micro- and macronutrient matched control product free of flavanols
Active Comparator: Flavanol rich product C 750 mg flavanols	Dietary Supplement: Flavanol rich intervention; Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols); Dietary Supplement: Flavanol free intervention; Calorically, micro- and macronutrient matched control product free of flavanols
Placebo Comparator: Flavanol free product flavanol free	Dietary Supplement: Flavanol rich intervention; Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)

Outcome Measures

Primary Outcome Measures

1. Absolute change of Flow-mediated Vasodilation (FMD) [2 hours]

Secondary Outcome Measures

1. Pulse wave velocity [2 hours]

   Measured by SphygmoCor

2. Augmentation index [2 hours]

   Measured by SphygmoCor

3. Ambulatory blood pressure [2 hours]

   automatical measurements

4. Plasma flavanol metabolites [2 hours]

   Measured by HPLC

5. laboratory safety parameters [2 hours]

   blood/urine samples for safety assessment (haematology, biochemistry, and urinalysis)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy post-menopausal femal subjects (>50 years)

• healthy male subjects (>50 years)

Exclusion Criteria:

• acute inflammation

• cardiac arrhythmia

• renal failure

• heart failure (NYHA II-IV)

• diabetes mellitus

• CRP > 1 mg/dl

• malignant disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Pulmonology and Vascular Medicine	Duesseldorf		Germany	40225

Sponsors and Collaborators

• Heinrich-Heine University, Duesseldorf

Investigators

• Principal Investigator: Christian Heiss, MD, Division of Cardiology, Pulmonology and Vascular Medicine
• Principal Investigator: Ana Rodriguez Mateos, PhD, Division of Cardiology, Pulmonology and Vascular Medicine
• Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonology and Vascular Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
• ClinicalTrials.gov Identifier: NCT02147223
• Other Study ID Numbers: BRANDED
• First Posted: May 26, 2014
• Last Update Posted: Apr 16, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf: flavanols; sex-related cardiovascular effects
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Apr 16, 2015