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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00795834

Enrollment

Registered

2008-11-21

Start date

2008-06-30

Completion date

2009-03-31

Last updated

2008-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

polyphenolics, flavonols, lipids, endothelial function, vascular risk factors

Brief 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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTHigh 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)

DIETARY_SUPPLEMENTPlacebo 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)	Baseline and post intervention

Secondary

Measure	Time frame
Established and novel blood markers for vascular disease	baseline and post intervention

Countries

United Kingdom

Contacts

Primary ContactAdam WF Mullan, MBChB MRCP

a.mullan@clinmed.gla.ac.uk+44-141-330-2569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026