Cognitive Function Clinical Trial
Official title:
Effects of Daily Tree Nut Consumption on Cognitive Function, Metabolomics and Intestinal Microbiota
Verified date | May 2018 |
Source | Northumbria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Tree nuts (for example brazil nuts, almonds, hazelnuts, walnuts, cashew nuts etc) contain a
wide variety of nutrients including fatty acids, polyphenols and micronutrients. The
beneficial health effects ascribed to the consumption of tree nuts include improvements to
cardiovascular outcomes and regulation of glucose levels and inflammation. Emerging evidence
suggests that specific components of nuts may also contribute to brain health and function.
The aim of the present study is to assess the effects of four weeks' supplementation of nut
components on cognition and subjective measures. Urinary metabolites and intestinal microbial
communities will also be assessed allowing biomarkers of nut exposure to be highlighted.
Status | Completed |
Enrollment | 81 |
Est. completion date | October 19, 2018 |
Est. primary completion date | October 19, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Healthy - Willing to abstain throughout the trial from any nutritional supplementation - Willing to abstain throughout the trial from the intake of any nuts or nut containing products Exclusion Criteria: - Aged under 18 or over 49 - Relevant pre-existing medical condition/illness - Current use of prescription medications (excluding contraception) - Learning difficulties and dyslexia - Visual impairment that cannot be corrected with glasses or contact lenses including colour blindness - Currently suffer from migraines (> 1 per month) - Smoking or use of any nicotine replacement products e.g. vaping, gum, patches - History of or any current food intolerances/sensitivities, including nut/peanut allergies - Never consumed nuts, or regularly consume nuts more than twice per week - Irregular bowel function (less than one bowel movement per day) - Body mass index (BMI) under 18.5 or over 30 - Pregnancy, seeking to become pregnant, or current lactation - Inability to complete all of the study assessments - Current participation in other clinical or nutrition intervention studies - Not proficient in English equivalent to IELTS band 6 or above - Have any known active infections - Blood pressure >139/89mmHg - Are employed in a job that includes night shift work - Have habitually used supplements within the last month (defined as more than 3 consecutive days or 4 days in total) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northumbria University | Newcastle upon Tyne | Tyne & Wear |
Lead Sponsor | Collaborator |
---|---|
Northumbria University | International Nut and Dried Fruit Council |
United Kingdom,
Mora-Cubillos X, Tulipani S, Garcia-Aloy M, Bulló M, Tinahones FJ, Andres-Lacueva C. Plasma metabolomic biomarkers of mixed nuts exposure inversely correlate with severity of metabolic syndrome. Mol Nutr Food Res. 2015 Dec;59(12):2480-90. doi: 10.1002/mnfr.201500549. Epub 2015 Oct 21. — View Citation
Pribis P, Bailey RN, Russell AA, Kilsby MA, Hernandez M, Craig WJ, Grajales T, Shavlik DJ, Sabatè J. Effects of walnut consumption on cognitive performance in young adults. Br J Nutr. 2012 May;107(9):1393-401. doi: 10.1017/S0007114511004302. Epub 2011 Sep 19. — View Citation
Rita Cardoso B, Apolinário D, da Silva Bandeira V, Busse AL, Magaldi RM, Jacob-Filho W, Cozzolino SM. Effects of Brazil nut consumption on selenium status and cognitive performance in older adults with mild cognitive impairment: a randomized controlled pilot trial. Eur J Nutr. 2016 Feb;55(1):107-16. doi: 10.1007/s00394-014-0829-2. Epub 2015 Jan 8. — View Citation
Tulipani S, Llorach R, Jáuregui O, López-Uriarte P, Garcia-Aloy M, Bullo M, Salas-Salvadó J, Andrés-Lacueva C. Metabolomics unveils urinary changes in subjects with metabolic syndrome following 12-week nut consumption. J Proteome Res. 2011 Nov 4;10(11):5047-58. doi: 10.1021/pr200514h. Epub 2011 Sep 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Logical reasoning | Cognition - executive function | At 28 days post dose, adjusted for baseline | |
Secondary | Location learning | Cognition - spatial memory | At 28 days post dose, adjusted for baseline | |
Secondary | Choice reaction time | Cognition - attention | At 28 days post dose, adjusted for baseline | |
Secondary | Rapid Visual Information Processing | Cognition - working memory | At 28 days post dose, adjusted for baseline | |
Secondary | Numeric working memory | Cognition - working memory | At 28 days post dose, adjusted for baseline | |
Secondary | Stroop | Cognition - executive function | At 28 days post dose, adjusted for baseline | |
Secondary | Peg and Ball | Cognition - executive function | At 28 days post dose, adjusted for baseline | |
Secondary | Word recall | Cognition - episodic memory | At 28 days post dose, adjusted for baseline | |
Secondary | Word recognition | Cognition - episodic memory | At 28 days post dose, adjusted for baseline | |
Secondary | Picture recognition | Cognition - episodic memory | At 28 days post dose, adjusted for baseline | |
Secondary | Bond-Lader | Mood | At 28 days post dose, adjusted for baseline | |
Secondary | Profile of Mood States (POMS) | Mood | At 28 days post dose, adjusted for baseline | |
Secondary | Urinary metabolites (fingerprinting and profiling) | Liquid chromatography/mass spectrometry, combined with data mining using specific software to identify specific metabolites influenced by supplementation | At 28 days post dose, adjusted for baseline | |
Secondary | Intestinal microbial communities | Analysis of total DNA using standardised procedures targeting bacteria using the 16S rRNA gene. | At 28 days post dose, adjusted for baseline |
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