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. 2020 Jan 17;2020(1):CD011919. doi: 10.1002/14651858.CD011919.pub2

NCT01881347.

Trial name or title Acronym:
Methods Type of trial: efficacy trial
Allocation: randomised
Intervention model: cross‐over assignment
Masking: double‐blinded (participants, caregiver, investigator, outcomes assessor)
Primary purpose: basic science
Participants Condition: type 2 diabetes mellitus
Enrolment: estimated 50
Inclusion criteria
  • Males and females

  • Over 21 years old

  • Body mass index < 38 kg/m²

  • Clinical stable type 2 diabetes mellitus


Exclusion criteria
  • Women who are lactating or pregnant

  • Treatment with an investigational product within 30 days of screening

  • Clinically evident major illness of other organ systems, including cancer, renal failure, or other conditions that in the opinion of investigators would make clinical study inappropriate

  • Liver transaminase levels > 3 times the upper limit of normal

  • History of psychological illness or condition that would interfere with person's ability to understand requirements of the study

  • Vitamin supplements exceeding 2 times the recommended daily allowance

  • Resveratrol or other dietary supplements except for a daily multi‐vitamin

Interventions Intervention(s): resveratrol supplement (100 mg daily for 2 weeks followed by 300 mg daily for 2 weeks)
Comparator(s): placebo
Outcomes Primary outcome(s): change from baseline in brachial artery flow‐mediated dilation
Secondary outcome(s): change from baseline in fingertip peripheral arterial tonometry, change from baseline in carotid femoral pulse wave velocity, change from baseline in reactive hyperaemia
Other outcome(s): change from baseline in serum glucose, change from baseline in serum insulin, change from baseline in mononuclear cell mitochondrial DNA damage, change from baseline in mononuclear cell mitochondrial mass, change from baseline in mononuclear cell mitochondrial production of reactive oxygen species, change from baseline in endothelial cell gene expression, change from baseline in endothelial cell protein expression
Starting date Trial start date: June 2013
Trial completion date: June 2016
Contact information Responsible party/principal investigator: Joseph A Vita, MD, Boston University (Contact: Monika Holbrook: monica.holbrook@bmc.org)
Study identifier Trial identifier:NCT01881347
Official title Dose response evaluation of resveratrol supplementation on cerebrovascular function, mood and cognitive performance in type 2 diabetes mellitus (T2DM)
Stated purpose of study Quote: "a dose response evaluation of resveratrol supplementation on cerebrovascular function, mood and cognitive performance in type 2 diabetes mellitus"
Notes