Effects of a Beverage Rich in Fruit Extracts on Risk Factors Associated With Cardiovascular Disease

Cardiovascular Disease Clinical Trial

Official title:

Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00795834
• Other study ID #: 07/S0704/110
• Secondary ID: RN08BI013
• Status: Recruiting
• Phase: N/A
• First received: November 19, 2008
• Last updated: November 19, 2008
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2008
• Source: University of Glasgow
• Contact: Adam WF Mullan, MBChB MRCP
• Phone: +44-141-330-2569
• Email: a.mullan[@]clinmed.gla.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of a novel beverage rich in polyphenols (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.

Description:

This study will assess the potential of a beverage containing plant and fruit extracts rich in polyphenolics to modulate vascular risk.

Novel risk factors for vascular disease will be assessed including non-invasive assessment of vascular function by pulse wave analysis / pulse wave velocity and laser doppler iontophoresis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Age >/= 55 years

• BMI > 25

Exclusion Criteria:

• Present smoker or smoked within the last 2 years

• HBA1C > 6.0%

• eGFR<60

• LFT >/= 3 times upper limit of normal

• Hypertension: systolic blood pressure > 160mmHg; diastolic blood pressure > 90mmHg, or on medication for hypertension.

• Chronic disease, likely to be clinically relevant (eg:

cardiorespiratory, rheumatological, cerebrovascular or neoplastic disease)

• Vitamin supplements within the previous 14 days

• Medications which, in the opinion of the investigators, are known to influence vascular function (eg corticosteroids).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• High polyphenol beverage
Antioxidant capacity umol TE/L(ORAC): 19987 Polyphenolic Content(mcg/ml): 1445 Vitamin C (mg/100ml): 35.35 Calorie Content (Kcal/250ml):40.0 250ml twice daily for 1 month (56 doses)
• Placebo Beverage
Antioxidant capacity umol TE/L(ORAC): negligible Polyphenolic Content(mcg/ml): negligible Vitamin C (mg/100ml): 0.00 Calorie Content (Kcal/250ml):40.0 250ml twice daily for 1 month (56 doses)

Locations

Country	Name	City	State
United Kingdom	British Heart Foundation Glasgow Cardiovascular Research Centre	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)		Baseline and post intervention	No
Secondary	Established and novel blood markers for vascular disease		baseline and post intervention	No