Clinical trial NCT02996578: Effect of Polyphenol-rich Cocoa Products on Cognitive Function
Official title: Consumption of Polyphenol Rich Cocoa Products Over 8 Weeks and Its Effect on Cognitive Function in Individuals in Their 5th Decade of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Ageing
Keywords: Cognition
Cacao
Flavan-3-ols
Blood Pressure
hemoglobin A1c protein, human
Memory
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Function
timeFrame: 8 weeks
Secondary outcomes:
measure: Blood Pressure
timeFrame: 8 weeks
measure: Pulse Wave Analysis
timeFrame: 8 weeks
measure: Glycated Haemoglobin (HbA1c)
timeFrame: 8 weeks
measure: Weight (Kg)
timeFrame: 8 weeks
measure: Height (m)
timeFrame: 8 weeks
measure: Body Fat Percentage
timeFrame: 8 weeks
measure: Energy intakes (Kj)
timeFrame: 8 weeks
measure: Flavonoid intakes (mg)
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Queen Margaret University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.