Effect of Polyphenol-rich Cocoa Products on Cognitive Function

NCT ID: NCT02996578

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Healthy cognitive ageing is an important aspect of the ageing process as it involves larger numbers of people compared to those who have already been diagnosed with conditions on the dementia spectrum (Deary et al, 2009). Hence, an active effort looking at potential lifestyle factor modification interventions to help maintain cognitive well-being are warranted.

With an ageing population, the prevalence of cognitive syndromes such as Alzheimer's disease and Parkinson's disease increases (Vauzour, 2012). Nutritional interventions can play a role in successful ageing by helping to delay the onset of age-related conditions (Hendrickx, McEwen \& van der Ouderaa, 2005; Brown, Riby \& Reay, 2009; Monti, Moulton \& Cohen, 2015). Studies have investigated the potential role of polyphenols as part of a neuroprotective lifestyle. Mouse model studies have looked at varying polyphenol sources such as tea (Haque et al., 2006; Kaur et al., 2008), blueberry (Shukitt-Hale et al., 2015; Williams et al., 2008), Gingko Biloba (Shif et al., 2008) and cocoa (Bisson et al., 2008) to mention a few.

Ageing and neurodegenerative diseases are caused by neuronal death which in turn can be triggered by neurotoxins, neuroinflammation and specific genetic mutations (Bishop, Lu \& Yankner, 2010). Dietary polyphenols have been observed to provide neuroprotection against cellular alteration by modulating the neuronal function against endogenous neurotoxins and inhibition of glial induced neuroinflammation (Vauzour, 2012).

Conditions

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Healthy Ageing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Solid Matrix - Intervention

Dietary Supplement: polyphenol rich chocolate bar

17.5g of commercially available dark chocolate will be consumed daily for 8 weeks

Group Type ACTIVE_COMPARATOR

polyphenol rich chocolate bar

Intervention Type DIETARY_SUPPLEMENT

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

Powder Matrix - Intervention

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

Group Type ACTIVE_COMPARATOR

polyphenol rich cocoa powder

Intervention Type DIETARY_SUPPLEMENT

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

Solid Matrix Intervention - Placebo

Dietary Supplement: low polyphenol chocolate

17.5g of commercially available, nutritionally similar, dark chocolate will be consumed daily for 8 weeks

Group Type PLACEBO_COMPARATOR

low polyphenol content chocolate bar

Intervention Type DIETARY_SUPPLEMENT

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

Powder Matrix - Placebo

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

Group Type PLACEBO_COMPARATOR

low polyphenol content cocoa powder

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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polyphenol rich chocolate bar

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

Intervention Type DIETARY_SUPPLEMENT

polyphenol rich cocoa powder

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

Intervention Type DIETARY_SUPPLEMENT

low polyphenol content chocolate bar

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

Intervention Type DIETARY_SUPPLEMENT

low polyphenol content cocoa powder

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Margaret University

OTHER

Sponsor Role lead

Responsible Party

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Ruth Ashaye

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Queen Margaret University

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 19776035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22701758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16290269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20054730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26650244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16549472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18078701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26392037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18457678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16740301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18179729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20336135 (View on PubMed)

Other Identifiers

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QueenMUra

Identifier Type: -

Identifier Source: org_study_id

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