Cerebral Blood Flow Effects of Resveratrol and Piperine in Humans

This study has been completed.
Sponsor:
Information provided by:
Northumbria University
ClinicalTrials.gov Identifier:
NCT01331382
First received: April 6, 2011
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

Resveratrol is associated with a plethora of physiological effects in humans, including modulation of cerebral blood flow, despite apparently poor bioavailability. This study investigated whether the physiological effects of resveratrol could be affected when co-supplemented with piperine, an alkaloid which may be able to enhance the bioavailability of resveratrol.


Condition Intervention
Healthy
Dietary Supplement: Trans- resveratrol
Other: Placebo (silica)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Resveratrol Alone or in Combination With Piperine on Cerebral Blood Flow Parameters and Cognitive Performance in Humans

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Modulation of levels of total haemoglobin [ Time Frame: 80 minutes following treatment administration ] [ Designated as safety issue: No ]
  • Modulation of levels of deoxygenated haemoglobin [ Time Frame: 80 minutes following treatment administration ] [ Designated as safety issue: No ]
  • Modulation of levels of oxygenated haemoglobin [ Time Frame: 80 minutes following treatment administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants displaying significant modulation of cognitive performance [ Time Frame: 40-80 minutes post dose ] [ Designated as safety issue: No ]
    Cognitive performance was assessed at baseline and then again 40 minutes post-treatment to assess if any changes had taken place.


Enrollment: 23
Study Start Date: April 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 250mg trans- resveratrol Dietary Supplement: Trans- resveratrol
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.
Other: Placebo (silica)
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.
Experimental: 250mg trans-resveratrol with 20mg piperine Dietary Supplement: Trans- resveratrol
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.
Other: Placebo (silica)
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.
Placebo Comparator: Placebo Dietary Supplement: Trans- resveratrol
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.
Other: Placebo (silica)
All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 18-35 years old
  • Healthy
  • Non-smoker

Exclusion Criteria:

  • Not proficient in English
  • Taking medication or herbal supplements
  • Pregnant or breast feeding
  • Heavy caffeine consumer
  • History of head trauma, migraines, learning difficulties, ADHD, gastrointestinal problems.
  • Food allergies of intolerances
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331382

Locations
United Kingdom
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
Principal Investigator: Emma L Wightman Northumbria University
  More Information

No publications provided by Northumbria University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emma Wightman, Northumbria university
ClinicalTrials.gov Identifier: NCT01331382     History of Changes
Other Study ID Numbers: 22AB2
Study First Received: April 6, 2011
Last Updated: April 7, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
Resveratrol
Piperine
Cerebral blood flow
Near- infrared spectroscopy
Bioavailability

Additional relevant MeSH terms:
Resveratrol
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014