Effects of Cocoa on Ambulatory Blood Pressure and Vascular Function in Patients With Stage I Hypertension

NCT01672840 | Completed

• 1 other identifier: 2012-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed study Dose And Response to Cocoa (DARC), will examine variation in dose of cocoa-containing product consumption over an 8-week period and assess effects on blood pressure, endothelial function and arterial stiffness. The randomized, controlled, modified Latin square parallel design will compare the effects of two doses of cocoa consumption on blood pressure, endothelial function and arterial stiffness in 120 adults with stage 1 hypertension.

Conditions

Hypertension

Keywords

Stage 1 Hypertension; cocoa consumption; Blood pressure; Endothelial function; arterial stiffness

Outcome Measures

Primary Outcomes (2)

• Ambulatory Blood Pressure Monitoring (ABPM)

  Subjects will undergo 24-hour ambulatory blood pressure monitoring using a FDA approved device (Model 90207 with standard adult cuff or large cuff (depending on arm size), Spacelabs Medical, Inc.). BP will be measured every 30 minutes throughout the 24-hour monitoring period. Mean systolic, mean diastolic, and average mean blood pressure will be calculated from all valid BP measurements. Daytime and nighttime (11:00 PM till 6:30 AM) BP will also be assessed.

  8 weeks

• Office Blood Pressure

  Systolic and diastolic BP will be measured at each visit using an approved automated device. Blood pressure will be measured (average of three measurements with five minutes between measurements) with the participant sitting in a quiet room.

  8 Weeks

Secondary Outcomes (9)

• Flow-mediated dilatation (FMD)

  8 Weeks

• Central Aortic Stiffness

  8 Weeks

• Fasting Serum Lipids

  8 Weeks

• C-Reactive Protein (CRP)

  8 Weeks

• Fasting Glucose and Insulin

  8 Weeks

Study Arms (2)

5g Cocoa Consumption

EXPERIMENTAL

Daily consumption of 10g Extra Dark cholocate and a beverage containing 2.5g of cocoa powder for 8 weeks

Dietary Supplement: 5g Cocoa Consumption

10g Cocoa Consumption

EXPERIMENTAL

Daily consumption of 20g Extra Dark cholocate and two beverage containing 2.5g of cocoa powder each for 8 weeks

Dietary Supplement: 10g Cocoa Consumption

Interventions

5g Cocoa Consumption DIETARY_SUPPLEMENT

Daily consumption of 10g Extra Dark cholocate and a beverage containing 2.5g of cocoa powder for 8 weeks

5g Cocoa Consumption

10g Cocoa Consumption DIETARY_SUPPLEMENT

Daily consumption of 20g Extra Dark cholocate and two beverage containing 2.5g of cocoa powder each for 8 weeks

10g Cocoa Consumption

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women age 18-75 years
• stage 1 hypertension (i.e. 140-159/90-99 mmHg) without anti-hypertensive medication or with only one anti-hypertensive medicaion
• body mass index \< 35 kg/m²
• willing to discontinue the use of chocolate/cocoa products at least 4 weeks prior to intervention.

You may not qualify if:

• anticipated inability to complete or comply with study protocol
• use of lipid-lowering or aspirin unless stable on medication for at least 1 month and willing to refrain from taking medication for 12 hours prior to endothelial function scanning
• severe hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100 mmHg), or use more than one anti-hypertensive medications
• allergic to cocoa products (chocolate or cocoa powder)
• regular use of vitamin C, vitamin E, fish oil, flax seed oil, omega-3 fatty acids, Coenzyme Q10, fiber supplements, garlic pills, arginine, red yeast rice, and/or any kind of antioxidant and unwilling to discontinue supplementation for at least 4 weeks prior to study initiation and for the study duration. Use of a multi-vitamin containing no more than two times the recommended daily allowance for vitamins C and E is permissible
• diagnosed eating disorder
• on any specific diet, weight control diet, and/or vegan diet
• substance abuse (chronic alcoholism and/or other chemical dependency)
• any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
• current or impending pregnancy. In premenopausal women, pregnancy will be excluded by pregnancy test at the time of each study visit.

Sponsors & Collaborators

• Griffin Hospital: lead
• Boston University: collaborator

Study Sites (2)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Valentine Njike, MPH, MD

  Yale-Griffin Prevention Research Center

  PRINCIPAL INVESTIGATOR

• Joseph A. Vita, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

US (2)