CompletedPhase 2ACTRN12611001288910

The effect of resveratrol in red wine on cognitive function in older adults: Preliminary study


Sponsor

Swinburne University of Technology

Enrollment

20 participants

Start Date

Jan 4, 2012

Study Type

Interventional

Conditions

Summary

This pilot study aims to assess the effects of a daily moderate amount of resveratrol-enhanced red wine on cognitive performance in older adults. This is a preliminary study to determine if a 100mg dose of resveratrol in wine has clinically significant effects on cognition.


Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Inclusion Criteria7

  • Participants who meet the following eligibility criteria will be recruited in the trial:
  • Healthy non-smoking males and females aged 65 or older.
  • No history of anxiety, depression or epilepsy.
  • Not taking any form of medication within 5 days of participation in the study (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study.
  • Are willing and able to participate in all scheduled visits, treatment plan, dietary restrictions, tests and other trial procedures according to the protocol. Also comfortable with computers.
  • Understand the rating scales and computer tests (as judged by the study coordinator)
  • Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.

Exclusion Criteria9

  • Participants presenting with any of the following will not be included in the trial:
  • Cigarette smoker
  • Heavy drinker of alcohol (averages more than 2 standard drinks per day).
  • History of anxiety, depression, psychiatric disorders or epilepsy
  • Currently taking (or have taken in the last 4 weeks) any anticoagulant or anti-platelet medications (such as warfarin, aspirin and others)
  • Currently taking any illicit drugs and/or a history of substance abuse.
  • Allergies to any treatment products
  • Current participation in any other trials involving investigational or marketed products within 30 days prior to the practice day.
  • Any clinically relevant abnormalities in a volunteer’s medical history, physical examination, or results of laboratory tests.

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Interventions

Resveratrol belongs to a class of polyphenolic compounds called stillbenes, found largely in the skins of red grapes and root of Japanese knotweed. It is a fat-soluble compound typically used in orien

Resveratrol belongs to a class of polyphenolic compounds called stillbenes, found largely in the skins of red grapes and root of Japanese knotweed. It is a fat-soluble compound typically used in oriental medicine to treat diseases of the blood vessels, heart and liver. An increasing body of evidence from in vitro, animal model and ex vivo studies suggest that resveratrol has the potential to prevent or reduce the risk of certain diseases such as cardiovascular disease, certain cancers (DNA-protective effects) and cognitive dysfunction or dementias. This study is a placebo-controlled, double-blind, randomised, repeated groups study, with a 7-day washout period between treatments. Participants will be required to attend 2 study visits. Visits will be scheduled to begin in the mornings as participants will be required to fast prior to testing. Each visit will progress in the same fashion and last for approximately 2.5 hours. Participants will complete a baseline 20-minute cognitive battery comprised of 2 repetitions of the Cognitive Demand Battery which consists of the serial three subtraction task, serial seven subtraction task and the Rapid Visual Information Processing Task. Following this a fasting blood sample will be taken as a baseline measure. Participants will then be given their treatment for the day. Participants will be randomised to receive either: 1) 100mg of grape derived resveratrol in 100ml red wine 2) 100ml red wine, such that at the conclusion of the study all participants will have received both treatments. A 45 minute absorption period is required prior to a second blood sample being taken. Following this, participants will complete a 60 minute cognitive battery comprised of 6 repetitions of the CDB. Following this, participants will be required to give a third blood sample. Finally, following a further 30 minutes, a fourth blood sample will be taken.


Locations(1)

VIC, Australia

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ACTRN12611001288910