The Effects of Resveratrol Supplementation on Cognition, Cerebral Blood Flow, Microbiota and Systemic Inflammation.

NCT03448094 | Completed

• 1 other identifier: 52P6
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Previous research shows that a diet high in fat has harmful effects on gut health. This increases the chance of developing obesity-related diseases (such as type 2 diabetes) and disrupts cognition and mood. Research has suggested that gut health can be improved by taking certain supplements, including resveratrol (a polyphenol found primarily in red grape skins). Resveratrol has also been shown to improve brain blood flow and possibly brain function - however, there is limited research studying this. This study will investigate the effects of 12 weeks daily consumption of resveratrol on cognitive function, cerebral blood flow, gut microbiota and systemic inflammation in overweight and obese healthy adults.

Conditions

Cognitive Function and Mood; Cerebral Blood Flow; Systemic Inflammation; Gut Microbiota; Overweight and Obesity

Outcome Measures

Primary Outcomes (8)

• Change from baseline cognitive (memory) performance at 45 minutes, 240 minutes and 12 weeks post dose

  Memory performance will be assessed using a computerised cognitive battery (administered using COMPASS cognitive assessment program). Memory will be assessed using 3 global measures (Working memory, speed of memory and episodic memory). The global measures are created by taking data from several tasks targeting that cognitive domain. Working memory: a combined accuracy score (% correct) from the tasks: numeric working memory (NWM), serial 3's subtractions (SS3), serial 7's subtractions (SS7) and rapid visual information processing (RVIP). Speed of memory: a combined speed score (msecs) from tasks NWM, delayed name to face recall, delayed picture recognition and delayed word recognition. Episodic memory: a combined accuracy score (% correct) from tasks immediate word recall, delayed word recall, delayed name to face recall, delayed picture recognition, delayed word recognition.

  45 minutes, 240 minutes, 12 weeks

• Change from baseline cognitive (Attention) performance at 45 minutes, 240 minutes and 12 weeks post dose

  Attention performance will be assessed using a computerised cognitive battery (administered using COMPASS cognitive assessment program). Attention will be assessed using 2 global measures (Accuracy of Attention and Speed of Attention). Accuracy of Attention: accuracy score (% correct) from choice reaction time task. Speed of attention: speed score (msecs) taken from choice reaction time task.

  45 minutes, 240 minutes, 12 weeks

• Gut microbiota

  Changes in gut microbiota communities, quantified using 16S ribosomal ribonucleic acid (rRNA) gene community analysis.

  12 weeks

• Change from baseline systemic inflammatory cytokines

  Inflammatory cytokines (including C-reactive protein and Interleukin-6) will be measured in plasma using ELISA analysis, in association with other endpoints including resveratrol metabolites.

  5 hours, 12 weeks

• Change from baseline urinary and plasma metabolome

  Changes in plasma and urinary metabolome will be profiled using a Thermo Q-Exactive liquid chromatography/mass spectrometry spectrometer and data analysed using Progenesis QI.

  12 weeks

• Change from baseline total haemoglobin cerebral blood flow (CBF) measurement

  CBF of the frontal cortex measured using quantitative near infrared spectroscopy (q-NIRS).

  115-190 minutes, 12 weeks

• Change from baseline deoxygenated haemoglobin CBF measurement

  CBF of the frontal cortex measured using qNIRS.

  115-190 minutes, 12 weeks

• Change from baseline oxygen saturation CBF measurement

  CBF of the frontal cortex measured using qNIRS.

  115-190 minutes, 12 weeks

Secondary Outcomes (4)

• Change from baseline Blood Pressure

  45 minutes, 240 minutes, 12 weeks

• Change from baseline Heart Rate

  45 minutes, 240 minutes, 12 weeks

• Change from baseline subjective mood score

  240 minutes, 12 weeks

• Weight change and BMI

  12 weeks

Study Arms (2)

Resveratrol

EXPERIMENTAL

500mg of Veri-te Resveratrol (consumed as two 250mg tablets, at two timepoints each day).

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

Matched placebo capsules (1 capsule consumed at two timepoints each day).

Dietary Supplement: Placebo

Interventions

Resveratrol DIETARY_SUPPLEMENT

Participants will consume one of the treatment types daily for a period of three months.

Also known as: Veri-teTM Resveratrol

Resveratrol

Placebo DIETARY_SUPPLEMENT

Participants will consume one of the treatment types daily for a period of three months.

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Interested in taking part in the study
• Healthy
• Aged 35-60 years (inclusive)
• Have a BMI of between 25-39.9
• Willing to consume your normal diet during the 12 week supplementation period

You may not qualify if:

• You should not take part if you:
• Are aged under 35 or over 60
• Have a Body Mass Index (BMI) lower than 25 or higher than 39.9.
• Have taken antibiotics (including pre- and pro-biotic supplements/drinks) during the previous 8 weeks
• Have irregular bowel movements (less than 1 per day)
• Have any pre-existing medical conditions/illness with some exceptions - please check with the researcher
• Have type 1 or type 2 diabetes
• Are currently taking prescription medications with some exceptions- please check with the researcher
• Have a visual impairment that cannot be corrected by glasses or contact lenses, including colour blindness.
• English is not your first language or your English proficiency is not equivalent to the International English language test system (IELTS) band 6 or above
• Have any learning difficulties or dyslexia
• Currently suffer from frequent migraines that require medication (\>1 per month)
• Have any food allergies, intolerances or sensitivities
• Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
• Smoke

Sponsors & Collaborators

• Northumbria University: lead
• Evolva SA: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Emma Wightman, Dr

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Researcher

Model Details: Participants will recieve either Resveratrol or Placebo for a period of 3 months.

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 27, 2018
• Study Start: February 6, 2018
• Primary Completion: July 13, 2019
• Study Completion: July 13, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)