Trial Review

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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
Date results information initially provided
21/06/2024
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] 309653 0
None
Universal Trial Number (UTN)
U1111-1292-5419
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 329990 0
Dementia 329991 0
Obesity 329992 0
Condition category
Condition code
Neurological 326898 326898 0 0
Dementias
Diet and Nutrition 326899 326899 0 0
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] 326083 0
Treatment: Other
Intervention code [2] 326084 0
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] 334737 0
Cerebrovascular responsiveness to cognitive stimuli using a cognitive battery composed of NIH Toolbox and the trail making task (parts A and B).
Timepoint [1] 334737 0
Pre-intervention and 12 weeks after intervention commencement
Primary outcome [2] 334738 0
Cerebrovascular responsiveness to hypercapnia using a transcranial Dopper sonography
Timepoint [2] 334738 0
Pre-intervention and 12 weeks after intervention commencement
Primary outcome [3] 334739 0
Mean cognitive tests scores using NIH Toolbox battery,
Timepoint [3] 334739 0
Pre-intervention and 12 weeks after intervention commencement
Secondary outcome [1] 421908 0
Mean profile of mood states score
Timepoint [1] 421908 0
Pre-intervention and 12 weeks after intervention commencement
Secondary outcome [2] 421909 0
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..
Timepoint [2] 421909 0
Pre-intervention and 12 weeks after intervention commencement
Secondary outcome [3] 421910 0
Metabolic, inflammatory, haematological and general biochemical markers (serum and plasma). These are exploratory outcomes. This is a composite secondary outcome.
Timepoint [3] 421910 0
Pre-intervention and 12 weeks after intervention commencement
Secondary outcome [4] 421911 0
Changes in 6 minute walk test
Timepoint [4] 421911 0
Pre-intervention and 12 weeks after intervention commencement
Secondary outcome [5] 421912 0
Changes in handgrip strength test using a digital dynamometer.
Timepoint [5] 421912 0
Pre-intervention and 12 weeks after intervention commencement
Secondary outcome [6] 421913 0
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.
Timepoint [6] 421913 0
Pre-intervention and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
Be aged 50-80 years
Have a body mass index >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
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment and/or dementia
BMI greater than 25 kg/m2
resting blood pressure equal to or less than 180/100mmHg
Coronary heart disease
Congestive heart failure
Atrial fibrillation
Prior myocardial infarction
Carcinoma (not undergoing current active treatment)
Stroke
Aneurysm
Epilepsy
Multiple sclerosis
Parkinson’s disease
Neuropathies
Presence of a fistulae
Smoker
Allergic to intervention ingredients
High chilli consumption

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbers will be assigned and randomly allocated to participants upon enrolment. The code will be kept in a sealed envelope by a UniSQ staff member who is not involved in the study to ensure blinding to participants and primary investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods, i.e. minimisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analyses will be performed using SPSS for Windows (IBM, Chicago, USA). Normality of data will be assessed using a Shapiro-Wilk test. Comparisons between groups for baseline measures will be determined using an independent t-test or Mann-Whitney U-test for parametric and non-parametric data, respectively. A two-way analysis of variance (ANOVA) will be used to determine the effect of time (0 vs. 12 week) and treatment (control vs. placebo). Significant interaction effects will be followed by planned pairwise comparisons between groups using the Bonferroni method. Pearson product-moment correlation coefficients or Spearman’s Rho will be calculated to assess the relative percentage change from week 0 to week 12 for the CVR to hypercapnia, total composite CVR to cognitive stimuli and total composite cognitive score in the capsaicin group for parametric and non-parametric data, respectively. Effect sizes will be determined using Cohen’s d. Statistical significance will be set at P < 0.05. Results will be presented as means ± standard devidation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
14/08/2023
Date of last participant enrolment
Anticipated
1/06/2024
Actual
28/09/2023
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313844 0
University
Name [1] 313844 0
University of Southern Queensland
Country [1] 313844 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Country
Australia
Secondary sponsor category [1] 315672 0
None
Name [1] 315672 0
Address [1] 315672 0
Country [1] 315672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312994 0
USQ Human Research Ethics Committee
Ethics committee address [1] 312994 0
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Ethics committee country [1] 312994 0
Australia
Date submitted for ethics approval [1] 312994 0
18/11/2022
Approval date [1] 312994 0
01/12/2022
Ethics approval number [1] 312994 0
H212REA177

Summary
Brief summary
Cognitive decline is the primary symptom of dementia and is preceded by reduced brain blood vessel (i.e. cerebrovascular) function. Cognitive decline and cerebrovascular dysfunction are made worse by obesity, which results from a poor diet and low physical activity levels. These are increasingly prevalent in regional Australia and contribute to the increase in dementia rates, reducing quality of life of older Australians. Current preventive treatments for dementia focus on reducing risk factors, including exercise and diet, but these are associated with low compliance. Capsaicin, the spicey molecule in chilli, reduces fat mass and blood pressure in humans. It also improves markers of cardiovascular disease and cognitive decline in animal models of disease by reducing inflammation and improving blood vessel function. However, capsaicin can cause oral and gastrointestinal irritation, limiting its potential for human use. Capsimax is a unique beadlet encapsulation of capsaicin that prolongs capsaicin release in the gut, and prevents irritation associated with capsaicin ingestion. Hence, Capsimax is a safe and tolerable supplement that can be used to examine the effects of capsaicin in humans. We will conduct a randomised control trial that will investigate the effects of Capsimax supplementation for 12 weeks on cognition and cerebrovascular function in middle-aged to older, overweight and obese adults who are at risk of cognitive decline and dementia. This pilot study will be the first human study to explore the use of a capsaicin supplement in improving cognition and cerebrovascular function, thus providing a foundation for future use as a preventive treatment for dementia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126618 0
Dr Edward Bliss
Address 126618 0
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Country 126618 0
Australia
Phone 126618 0
+61 746315477
Fax 126618 0
Email 126618 0
Edward.Bliss@usq.edu.au
Contact person for public queries
Name 126619 0
Dr Edward Bliss
Address 126619 0
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Country 126619 0
Australia
Phone 126619 0
+61 746315477
Fax 126619 0
Email 126619 0
Edward.Bliss@usq.edu.au
Contact person for scientific queries
Name 126620 0
Dr Edward Bliss
Address 126620 0
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Country 126620 0
Australia
Phone 126620 0
+61 7 46315477
Fax 126620 0
Email 126620 0
Edward.Bliss@usq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only data underlying published results collected during the trial will be made available, after de-identification.
When will data be available (start and end dates)?
Once published (~31/12/2024). Hence, immediately following publication of any journal articles that are generated throughout the course of the study. No end date
Available to whom?
Individual data will also be available to the participants of the study on request.
De-identified data will be available for journal/conference proceedings.
Researchers on the project (i.e. co-investigators).
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Restricted access via UniSQ data portal (password protected) and this will be granted subject to approvals by Principal Investigator (Edward.Bliss@usq.edu.au).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.