Acute Hemodynamic Effects of Cocoa Polyphenols in Subjects With Hypertension and Optimal Blood Pressure

NCT00654862 | Completed Phase 1

• 1 other identifier: ECA-02-006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Intake of cocoa-containing foods has been found to lower blood pressure (BP) in several clinical trials. It is supposed that the cocoa polyphenols represent the active principle, lowering BP by increasing the formation of vasodilative nitric oxide. However, direct evidence for this assumption from controlled clinical studies is lacking. Moreover, in hypertensive subjects vascular dilation appears to be impaired due to endothelial dysfunction and vascular smooth muscle remodeling, but it is unclear whether the BP response to cocoa phenols differs between subjects with high blood pressure and optimal blood pressure. The investigators hypothesized that (1) intake of cocoa phenols cause a dose-dependent, acute elevation of circulating bioactive NO levels and a reduction in BP, and that (2) the NO elevation and BP reduction are impaired in patients with hypertension. To test this hypothesis, the investigators will conduct a prospective, randomized, placebo-controlled, double-blind, sample size-calculated, three-period crossover study with pre-planned statistical analysis and trial monitoring, in which cocoa phenols will be orally administered to subjects with mild essential hypertension or subjects with optimal blood pressure. The effects on blood pressure, heart rate, arterial function and plasma levels of cocoa phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress will be evaluated. After a 7-day cocoa-free run-in period and a 12-hour overnight fast, 48 subjects (24 with hypertension and 24 sex-, and age (+/- 2yrs)-matched subjects with optimal blood pressure) will receive either a single dose of 1000 mg cocoa polyphenols, 250 mg cocoa phenols or placebo (in capsules of equal form and weight). Each intervention will be followed by a 7-day cocoa-free washout period before cross-over to the subsequent intervention. Subjects will be allocated to the intervention sequence by permuted block randomization (i.e. permuted blocks of 2 subjects with high BP and 2 subjects with optimal BP each, are assigned to permutations of the tree interventions). Measurements of hemodynamic and plasma parameters will be performed directly before and 30, 60, 90, 120, 180, 300, and 480 min after capsule administration. Included subjects will be counseled to maintain their usual diet and physical activity and to abstain from all cocoa products during the study. Analysis of the data will be performed on an intention-to-treat basis.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in systolic and diastolic blood pressure

  Assessments at 3 time points

Secondary Outcomes (1)

• Changes in plasma levels of bioactive nitric oxide, arterial function, oxidation markers and cocoa polyphenols

  Assessments at 3 time points

Study Arms (2)

1

EXPERIMENTAL

Subjects with stage 1 hypertension

Dietary Supplement: cocoa polyphenols

2

EXPERIMENTAL

Subjects with optimal blood pressure

Dietary Supplement: cocoa polyphenols

Interventions

cocoa polyphenols DIETARY_SUPPLEMENT

Oral administration of capsules with 1000 mg polyphenols, 250 mg polyphenols or placebo

1

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unpaid volunteers of both sex between 50 and 75 years of age in good general health.
• Diagnosis of stage 1 essential hypertension (BP between 140/90 and 160/100 mmHg) or optimal BP below 120/80) and stable BP values.
• No antihypertensive medications or nutritional supplements.
• Non-manual workers or pensioners of higher socioeconomic status (household income of more than 20,000 €/year)
• Leisure physical activity of less than 7 METs per week
• Normal levels of plasma lipids and plasma glucose.

You may not qualify if:

• Cardiovascular diseases (other than hypertension).
• Diabetes mellitus.
• Hyper-/dyslipidemia.
• Gastrointestinal diseases
• Hepatic and renal disorders
• Pulmonary diseases.
• Coagulopathy.
• Cancer.
• Psychiatric disorders.
• Alcohol or drug dependence.
• Seizure disorders.
• History of organ transplantation.
• Surgery within the last 12 months.
• Positive tests for HIV, hepatitis B or C.
• Body-mass index of more than 27.5 or less than 18.5 kg/m2

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Department of Pharmacology, University of Cologne

Cologne, D-50931, Germany

Location

Related Publications (2)

• Taubert D, Roesen R, Lehmann C, Jung N, Schomig E. Effects of low habitual cocoa intake on blood pressure and bioactive nitric oxide: a randomized controlled trial. JAMA. 2007 Jul 4;298(1):49-60. doi: 10.1001/jama.298.1.49.

  PMID: 17609490 BACKGROUND

• Taubert D, Berkels R, Roesen R, Klaus W. Chocolate and blood pressure in elderly individuals with isolated systolic hypertension. JAMA. 2003 Aug 27;290(8):1029-30. doi: 10.1001/jama.290.8.1029. No abstract available.

  PMID: 12941673 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dirk Taubert, MD, PhD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Last Updated: February 18, 2009

Record last verified: 2009-02

Locations

DE (1)