Effect of Grape Seed Extract on Blood Pressure

NCT00869193 | Completed

• 1 other identifier: 08050V
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether an 8-week intervention with grape seed extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal female with elevated daytime blood pressure values.

Conditions

Elevated Blood Pressure

Keywords

Blood pressure; Grape seed

Outcome Measures

Primary Outcomes (1)

• Difference between treatment and placebo in changes from baseline of ambulatory systolic and diastolic blood pressure

  8 weeks of intervention

Secondary Outcomes (1)

• Difference between treatment and placebo in changes from baseline of mechanistic markers in plasma and/or urine (vasoactive factors and markers of polyphenol metabolism) and platelet function (only measured in case of a relevant BP-lowering effect)

  8 weeks of intervention

Study Arms (2)

Grape seed

ACTIVE COMPARATOR

Grape seed extract

Dietary Supplement: Grape seed extract

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose

Dietary Supplement: Microcrystalline cellulose (placebo)

Interventions

Grape seed extract DIETARY_SUPPLEMENT

Subjects will daily consume one capsule with grape seed extract for 8 weeks.

Also known as: Polyphenol

Grape seed

Microcrystalline cellulose (placebo) DIETARY_SUPPLEMENT

Subjects will daily consume one capsule with microcrystalline cellulose for 8 weeks.

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and postmenopausal female subjects in the age ≥ 35 and ≤ 75 at start of the study
• BMI ≥ 18.5 and ≤ 30.0 kg/m2
• Apparently healthy: no reported diseases that may affect study results and pre-selected blood parameters within normal range
• Informed consent signed
• Willing to refrain from supplements, food products, diets and drugs that may interfere with the outcomes of the study

You may not qualify if:

• Mean of 6-hour ambulatory SBP \< 120 mmHg, \> 159 mmHg and/or DBP \> 99 mmHg
• year risk mortality risk on CVD \> 10% according to NHG standard M84. For subjects \> 65 years of age and SBP ≥ 140 mmHg the study physician will assess eligibility
• Irregular pulse or pulse \< 50 or \> 100 bpm
• Intense exercise \>10 h/w
• Reported weight loss/gain \> 10% of body weight in the 6 month preceding pre-study examination
• The habit of smoking during the past year

Sponsors & Collaborators

• Unilever R&D: lead
• University of Edinburgh: collaborator

Study Sites (1)

Unilever R&D Vlaardingen

Vlaardingen, 3133 AT, Netherlands

Location

MeSH Terms

Conditions

Hypertension

Interventions

Grape Seed Extract; Polyphenols; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Rouyanne T Ras, Msc

  Unilever R&D Vlaardingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 28, 2009

Record last verified: 2009-08

Locations

NL (1)