Brain health effects in at risk populations with chilli extract supplementation

INTERVENTION: The objective of this research is to investigate the effects of Capsima Xon cerebrovascular function and cognition in middle‐aged to older adults. A randomised, double‐blind, placebo‐controlled that aims to determine whether 200mg of Capsima Xfor 12 weeks can improve cerebrovascular function and cognition in middle‐aged to older, overweight and obese adults who are at risk of cognitive decline and dementia. It is hypothesised that Capsima Xwill improve cognition and in this cohort by improving cerebrovascular function, as well as improving cardiovascular function and general physiological and psychological markers of health. We will aim to recruit 40 participants for this study. Recruitment will occur via an approved media release that incorporates physical advertisement, social media and information on the UniSQ website. The individuals will be recruited from community organisations in and around Ipswich, Darling Downs and Moreton Bay regions of Australia. Respondents will initially be screened for suitability using a medical history questionnaire to determine whether participants meet the inclusion and/or exclusion criteria. Once participants are recruited, voluntary written informed consent will be obtained prior to any assessment being performed and their allocation to one of the two arms of the study. Further, participants will be asked to complete a nutritional questionnaire at 0, 6 and 12 weeks, so that this can be assessed and that any effects that are noted throughout the study are due to the Capsima Xintervention and not due to changes in nutritional behaviour. Further, participants will also complete the Yale Physical Activity Survey to determine physical activity behaviour so that any changes observed are due to the Capsima Xintervention and not increased CONDITION: Cognitive impairment;Dementia;Obesity; ; Cognitive impairment ; Dementia ; Obesity Diet and Nutrition ‐ Obesity Neurological ‐ Dementias PRIMARY OUTCOME: Cerebrovascular responsiveness to cognitive stimuli using a cognitive battery composed of NIH Toolbox and the trail making task (parts A and B).[Pre‐intervention and 12 weeks after intervention commencement; ] Cerebrovascular responsiveness to hypercapnia using a transcranial Dopper sonography; [Pre‐intervention and 12 weeks after intervention commencement; ] Mean cognitive tests scores using NIH Toolbox battery, [Pre‐intervention and 12 weeks after intervention commencement; ] INCLUSION CRITERIA: Be aged 50‐80 years Have a body mass inde X>25 kg/m2 (we will calculate this) Have blood pressure below 180/100mmHg (we will determine this at the screening visit) Not have heart, cancer (active treatment) or a neurological disorder Not have an allergy to or related to intervention ingredients SECONDARY OUTCOME: Cardiovascular profile (arterial stiffness and blood pressure) using a non‐invasive HDI/Pulsewave™ CR‐2000 Research Cardiovascular Profiling System. This is a composite secondary outcome.. ; [Pre‐intervention and 12 weeks after intervention commencement ; ] Changes in 6 minute walk test ; [Pre‐intervention and 12 weeks after intervention commencement ; ] Changes in body composition using a Dual‐energy X‐ray absorptiometry (DEXA). Total fat mass, lean mass, body fat percentage, and bone mineral content and density will be assessed. ; [Pre‐intervention and 12 weeks after intervention commencement] Changes in handgrip strength test using a digital dynamometer. ; [Pre‐intervention and 12 weeks after intervention commencement] Mean profile of mood states score ; [Pre‐intervention and 12 weeks after intervention commencement ; ] Metabolic, inflammatory, haematological and general biochemical markers (serum and plasma). These are exploratory outcomes. This is a composite secondary outcome.[Pre‐intervention and 12 weeks after intervention commencement ; ]