NCT02996578

Brief Summary

This project aims to investigate whether consumption of cocoa polyphenols has an impact on cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a result of an improvement in risk factors associated with cognitive decline in ageing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

April 17, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

December 12, 2016

Last Update Submit

March 26, 2023

Conditions

Healthy Ageing

Keywords

CognitionCacaoFlavan-3-olsBlood Pressurehemoglobin A1c protein, humanMemory

Outcome Measures

Primary Outcomes (1)

  • Cognitive Function

    A test battery consisting of 7 tests will be used to investigate the role of cocoa flavanols on cognitive function in the cohort.

    8 weeks

Secondary Outcomes (8)

  • Blood Pressure

    8 weeks

  • Pulse Wave Analysis

    8 weeks

  • Glycated Haemoglobin (HbA1c)

    8 weeks

  • Weight (Kg)

    8 weeks

  • Height (m)

    8 weeks

  • +3 more secondary outcomes

Study Arms (4)

Solid Matrix - Intervention

ACTIVE COMPARATOR

Dietary Supplement: polyphenol rich chocolate bar 17.5g of commercially available dark chocolate will be consumed daily for 8 weeks

Dietary Supplement: polyphenol rich chocolate bar

Powder Matrix - Intervention

ACTIVE COMPARATOR

Dietary Supplement: polyphenol rich cocoa powder 6g of commercially available cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks

Dietary Supplement: polyphenol rich cocoa powder

Solid Matrix Intervention - Placebo

PLACEBO COMPARATOR

Dietary Supplement: low polyphenol chocolate 17.5g of commercially available, nutritionally similar, dark chocolate will be consumed daily for 8 weeks

Dietary Supplement: low polyphenol content chocolate bar

Powder Matrix - Placebo

PLACEBO COMPARATOR

Dietary Supplement: nutritionally similar low polyphenol cocoa powder 6g of commercially available, nutritionally similar, cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks

Dietary Supplement: low polyphenol content cocoa powder

Interventions

polyphenol rich chocolate barDIETARY_SUPPLEMENT

High polyphenol content chocolate bar. Each participant will consume 581.4mg of polyphenols

Solid Matrix - Intervention
polyphenol rich cocoa powderDIETARY_SUPPLEMENT

High polyphenol content cocoa powder. Each participant will consume 6g containing 554mg of polyphenols

Powder Matrix - Intervention
low polyphenol content chocolate barDIETARY_SUPPLEMENT

Low polyphenol content matched chocolate bar. Each participant will consume 198.5mg of polyphenols

Solid Matrix Intervention - Placebo
low polyphenol content cocoa powderDIETARY_SUPPLEMENT

Low polyphenol content cocoa powder. Each participant will consume 6g containing 191.2mg of polyphenols

Powder Matrix - Placebo

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males \& Females aged 50-60years of age with normal or corrected to normal vision
  • BMI cut off points of ≥18.5 to ≤29.9 kg/m2
  • Waist circumference smaller than 102cm for males \& smaller than 88cm for women
  • Blood pressure of ≥ 90 over 60 and ≤ 120 over 80
  • MoCA test score ≥ 26

You may not qualify if:

  • Allergies to cocoa or any other ingredients commonly found in cocoa confectionary eg: milk, nuts, soya
  • Smoker
  • Women who are new or expecting mothers, maybe or are currently pregnant and/or breastfeeding
  • Taking medications for chronic conditions including (but not limited to) diabetes, heart disease, hypertension
  • No previous history of stroke, brain trauma and other head-related injuries
  • No diagnosis of depression and/or anxiety
  • No previous cancer diagnosis
  • Taking antibiotics
  • Taking steroids and non-steroidal anti-inflammatory drugs (NSAIDS)
  • Women on Hormone Replacement Therapy (HRT)
  • Taking medication that can cause drowsiness or affect cognitive functioning
  • Taking polyphenol supplements including (but not limited to) green tea extract, acai berry extract
  • Taking soy/a supplements
  • History of alcohol misuse
  • Fear of needles and/or fainting when blood is taken

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Margaret University

Edinburgh, United Kingdom

Location

Related Publications (12)

  • Deary IJ, Corley J, Gow AJ, Harris SE, Houlihan LM, Marioni RE, Penke L, Rafnsson SB, Starr JM. Age-associated cognitive decline. Br Med Bull. 2009;92:135-52. doi: 10.1093/bmb/ldp033.

    PMID: 19776035BACKGROUND

  • Vauzour D. Dietary polyphenols as modulators of brain functions: biological actions and molecular mechanisms underpinning their beneficial effects. Oxid Med Cell Longev. 2012;2012:914273. doi: 10.1155/2012/914273. Epub 2012 Jun 3.

    PMID: 22701758BACKGROUND

  • Hendrickx H, McEwen BS, Ouderaa Fv. Metabolism, mood and cognition in aging: the importance of lifestyle and dietary intervention. Neurobiol Aging. 2005 Dec;26 Suppl 1:1-5. doi: 10.1016/j.neurobiolaging.2005.10.005. Epub 2005 Nov 14.

    PMID: 16290269BACKGROUND

  • Brown LA, Riby LM, Reay JL. Supplementing cognitive aging: a selective review of the effects of ginkgo biloba and a number of everyday nutritional substances. Exp Aging Res. 2010 Jan-Mar;36(1):105-22. doi: 10.1080/03610730903417960.

    PMID: 20054730BACKGROUND

  • Monti JM, Moulton CJ, Cohen NJ. The role of nutrition on cognition and brain health in ageing: a targeted approach. Nutr Res Rev. 2015 Dec;28(2):167-180. doi: 10.1017/S0954422415000141.

    PMID: 26650244BACKGROUND

  • Haque AM, Hashimoto M, Katakura M, Tanabe Y, Hara Y, Shido O. Long-term administration of green tea catechins improves spatial cognition learning ability in rats. J Nutr. 2006 Apr;136(4):1043-7. doi: 10.1093/jn/136.4.1043.

    PMID: 16549472BACKGROUND

  • Kaur T, Pathak CM, Pandhi P, Khanduja KL. Effects of green tea extract on learning, memory, behavior and acetylcholinesterase activity in young and old male rats. Brain Cogn. 2008 Jun;67(1):25-30. doi: 10.1016/j.bandc.2007.10.003. Epub 2007 Dec 19.

    PMID: 18078701BACKGROUND

  • Shukitt-Hale B, Bielinski DF, Lau FC, Willis LM, Carey AN, Joseph JA. The beneficial effects of berries on cognition, motor behaviour and neuronal function in ageing. Br J Nutr. 2015 Nov 28;114(10):1542-9. doi: 10.1017/S0007114515003451. Epub 2015 Sep 22.

    PMID: 26392037BACKGROUND

  • Williams CM, El Mohsen MA, Vauzour D, Rendeiro C, Butler LT, Ellis JA, Whiteman M, Spencer JP. Blueberry-induced changes in spatial working memory correlate with changes in hippocampal CREB phosphorylation and brain-derived neurotrophic factor (BDNF) levels. Free Radic Biol Med. 2008 Aug 1;45(3):295-305. doi: 10.1016/j.freeradbiomed.2008.04.008. Epub 2008 May 5.

    PMID: 18457678BACKGROUND

  • Shif O, Gillette K, Damkaoutis CM, Carrano C, Robbins SJ, Hoffman JR. Effects of Ginkgo biloba administered after spatial learning on water maze and radial arm maze performance in young adult rats. Pharmacol Biochem Behav. 2006 May;84(1):17-25. doi: 10.1016/j.pbb.2006.04.003. Epub 2006 Jun 5.

    PMID: 16740301BACKGROUND

  • Bisson JF, Nejdi A, Rozan P, Hidalgo S, Lalonde R, Messaoudi M. Effects of long-term administration of a cocoa polyphenolic extract (Acticoa powder) on cognitive performances in aged rats. Br J Nutr. 2008 Jul;100(1):94-101. doi: 10.1017/S0007114507886375. Epub 2008 Jan 8.

    PMID: 18179729BACKGROUND

  • Bishop NA, Lu T, Yankner BA. Neural mechanisms of ageing and cognitive decline. Nature. 2010 Mar 25;464(7288):529-35. doi: 10.1038/nature08983.

    PMID: 20336135BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 19, 2016

Study Start

April 17, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)