ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000556640

Ethics application status

Approved

Date submitted

12/05/2023

Date registered

24/05/2023

Date last updated

21/06/2024

Date data sharing statement initially provided

24/05/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Brain health effects in at risk populations with chilli extract supplementation

Scientific title

The effect of Capsimax on cerebrovascular function and cognition in middle-age to older overweight and obese adults: A pilot study

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1292-5419

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cognitive impairment

Dementia

Obesity

Condition category

Condition code

Neurological

Dementias

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The objective of this research is to investigate the effects of Capsimax on cerebrovascular function and cognition in middle-aged to older adults. A randomised, double-blind, placebo-controlled that aims to determine whether 200mg of Capsimax for 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 Capsimax will 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 Capsimax intervention 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 Capsimax intervention and not increased physical activity.
The two arms of this study will consist of a control group, which will receive a placebo (gel capsule with calcium carbonate filler taken orally), and a second arm (the Capsimax supplementation group) that will be requested to take two 100mg oral capsules per day with water, once in morning (1 capsule) and once in the evening (1 capsule) continuously for 12 weeks. Participants will be requested to record the time they consume their capsules in a supplement diary provided. The study investigator will follow-up with participants via a telephone call every two weeks to check wellbeing and compliance. Any unused capsules will be returned at the end of the intervention and counted to demonstrate compliance.
Once informed about the study and its requirements, by providing potential participants with a participant information sheet, participants that meet part of the inclusion criteria will attend UniSQ Ipswich or UniSQ Toowoomba for baseline screening and testing. Prior to the start of any testing during visit 1, informed consent will be first voluntarily obtained and once acknowledged, testing and screening will commence. These visits will incorporate the following methods:
• Cerebrovascular responsiveness to hypercapnia and cognitive stimuli (NIH Toolbox, Trail Making Task) using transcranial Doppler sonography;
• Profile of Mood States to ascertain current mood;
• Anthropometry, determined by body weight and height (body mass index calculation), waist and hip circumferences (waist to hip ratio calculation) and Dual-energy X-ray absorptiometry (DEXA) which will ascertain body composition of total fat mass, lean mass, body fat percentage, and bone mineral content and density;
• Systolic and diastolic blood pressure and arterial elasticity will be measured non-invasively using a Research Cardiovascular Profiling System;
• Biomarker analyses after blood is collected; and
• Exercise capacity will be assessed using a 6 minute walk test at 0 and 12 weeks and handgrip strength will be determined using hand dynamometry.

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Comparator / control treatment

One of the two arms of this study will consist of a control group, which will receive a placebo. The placebo will be a gel capsule with calcium carbonate filler taken orally.

Control group

Placebo

Outcomes

Primary outcome [1]

Cerebrovascular responsiveness to cognitive stimuli using a cognitive battery composed of NIH Toolbox and the trail making task (parts A and B).

Timepoint [1]