Oral Supplement in Older Adults to Support Physical Fitness and Mental Well-being
Phase: PHASE1
Conditions: Osteo-arthritis
Sponsor: Aberystwyth University

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
 
 
 
Cover page with official title: ORAL SUPPLEMENT IN OLDER ADULTS TO SUPPORT 
PHYSICAL FITNESS AND MENTAL WELL-BEING (ID, 23767, PQQA) 
 
NCT number:  
 
Document date: 21 April 2023 
 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
  
 
 
Table of Contents 
1) Introduction  
2) Statement of Purpose  
3) Investigational Product 
4) Investigational Product Safety 
5) Study Design 
6) Patient Risks 
7) Benefit To Subjects 
8) Ethical approval 
9) Privacy Confidentiality 
10) Safety Monitoring 
11) Data Analysis and Statistics 
12) References 
 
 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
 
1) Introduction 
Cucumbers have been anecdotally claimed to have anti-inflammatory activity for a long time, but the 
active principle was not identified. IdoBR1, (2R,3R,4R,5S)-3,4,5-trihydroxypiperidine-2-carboxylic 
acid, is an iminosugar amino acid isolated from fruits of certain cucumbers, Cucumis sativus 
(Cucurbitaceae), which has been shown to have anti-inflammatory activity in cells and ex vivo human 
blood.  
 
We will explore if consumption of cucumber extract Q-actin when compared with placebo can have 
an impact on physical strength (measured by hand grip strength), finger dexterity (measured by 
Nine-Hole Peg Test (9HPT)) as well as quality of life (EQ-5D questionnaire), sleep quality 
(Pittsburgh Sleep Quality Index), hip and knee pain (WOMAC questionnaire), and diet (diet 
questionnaires are tailored to your eating habits, e.g., carnivore, vegetarian pescetarian, vegan etc). 
We will explore urine chemical composition of home-collected urine using high resolution 
metabolomics. 
 
2) Statement of Purpose 
A randomized, placebo controlled clinical human trial of Q-actin (2 x 10 mg gummies daily) or 
placebo (2 x 10 mg gummies, taken twice daily before bed), in middle aged and older adults 
(>50), is proposed for a period of 12 weeks. The aim is to explore whether consumption of Q-
actin post intervention, and in comparison, to the placebo, has any impact on physical strength 
(measured by hand grip strength), finger dexterity (measured by Nine-Hole Peg Test (9HPT)), 
and hip or knee pain (WOMAC), as well as quality of life (EQ-5D questionnaire), sleep quality 
(Pittsburgh Sleep Quality Index (PSQI)), and diet (PDQS). Home-urine samples will be collected 
for the investigation into the chemical composition.  
 
3) Investigational Product 
 
3.1) 
Description 
Q-actin is an imino-sugar (idoBR1, (2R,3R,4R,5S)-3,4,5-trihydroxypiperidine-2-
carboxylic acid) isolated from fruits of certain cucumbers, Cucumis sativus 
(Cucurbitaceae). The daily dose will be 20mg, which will be divided into two vegan 
gummies (2x10mg) that are to be consumed before bed. The placebo is a gummy 
matching Q-actin in appearance, tase and texture, the ingredients for which are 
detailed in section 4.  
 
3.2) 
Quality 
Q-actin (and the matching placebo) will be consumed in the form of wax coated, 
square bottom gummies that are dark red in colour with natural raspberry flavouring. 
Vegan gummies were chosen as opposed to tablets because they are easier to consume 
than pills/capsules. Both Q-actin and the placebo have been manufactured by a fully 
licensed GMP site manufacturer. The gummies have been analysed and quality 
control screened for elemental elements and microbials and have passed, all according 
to guidelines.. 
 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
 
3.3) 
Dose 
The dose of Q-actin and the placebo will be 2x10mg gummies daily before bed, for a 
period of 12 weeks.  
 
4) Investigational Product Safety  
The Food Standards Agency have confirmed that Q-actin, can be used in clinical trials. A food 
grade statement for Q-actin has been obtained, and a GRAS document (Generally Recognised 
As Safe) status has been prepared for the producers in America (Gateway Health Alliances, 
Inc./IminoTech, Inc.) by Soni & Associates Inc. Gummy ingredients: Corn Syrup, Sugar, 
Purified Water, Pectin, Natural Flavours (raspberry), Citric Acid, MCT Oil, Natural Colors 
(vegetable concentrates), Carnauba Wax, Sodium Citrate 
 
5) Study Design 
 
5.1) Objectives of the Study 
The aim is to compare physical strength, finger dexterity, hip and knee pain, quality of life, sleep 
quality, diet, and urine chemical composition between baseline and post intervention after Q-actin 
and placebo control. 
 
5.2) Subject Selection 
- 
50 participants, over 50 years, mixed gender, mixed ethnicity 
 
- 
Inclusion Criteria: 
➢ Consenting adults >50 y Age. 
➢ Commit to urine sampling. 
➢ Able to commit to attending WARU or the remote centre for measurements of 
physical strength, finger dexterity, quality of life, sleep quality, hip and knee 
pain, and diet choices. 
➢ Able to restrict from consumption of cucumber, gherkins, and melon for two days 
before coming to WARU or the remote centre. 
 
- 
Exclusion Criteria: 
➢ Showing (or anyone within the household) any COVID-19 symptoms (see 
COVID-19 basic health screen).* 
➢ Higher risk or vulnerable from coronavirus or live with someone at a higher risk 
of a severe illness from COVID-19 (over 70, undergoing cancer treatment, high 
risk of getting infections). 
➢ Had a letter from the NHS advising you to shield (isolate). 
➢ Had been at risk of exposure to COVID-19 such as travel, contact with someone 
with COVID-19, been exposed to the virus, or has been asked to self-isolate by the 
track and trace system. 
➢ Serious health conditions that require daily long-term medication. 
- 
*If the potential participant has had COVID-19 previously (and are fully recovered 
and not within isolation) then they are eligible to join the study 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
 
5.2) 
Study Design 
This is a randomised, double-blinded, parallel study, where participants are asked to take the gummies 
(Q-actin or Placebo) twice a day for a period of 12 weeks. Within that 12 week period, participants 
will be required to make three visits to the Well-being and Health Assessment Research Unit 
(WARU) at Aberystwyth University, or to the remote facility in Trimsaran, following a pre-induction 
screening visit. Urine kits and study materials will be prepared (and stored) at the Well-Being and 
Health Assessment Research Unit (WARU) at Aberystwyth University. Urine samples will be 
assessed at AberInnovation and Aberystwyth University. 
 
 
Pre-Induction 
Participants are welcomed with tea or coffee and talked through how safe working practices are being 
conducted during coronavirus (COVID-19). Then they are introduced to the urine sampling boxes 
and provided with crib sheets and an email link to a video demonstration (if needed). They are talked 
through the logistics of study visits and the tasks that will be completed. They are asked to complete 
a medical health screening questionnaire, and height, weight, and BMI measurements are obtained. 
They are provided with the urine sampling kits complete with 1 needle, two sampling vacutainers and 
1 collection cup for each visit (week 0, week 6 and week 12). A review of their continued right to 
withdraw, in addition to the data protection and storage of their personal data and biofluids, is 
provided, and the dates and times of visits 1, 2 and 3 are arranged. A consent form is signed. This 
pre-induction can also be done remotely and materials posted. Consent forms are to be received and 
stored prior to the first sample collection. 
 
Visit 1  
Participants arrive on their pre-organised day and time with 2 x 4ml of their first urine sample (after 
being stored between 3-5 degrees Celsius in participants home fridge), collected at home using our 
urine kits. Consent is obtained followed by the first assessment of physical strength, finger dexterity, 
quality of life (EQ-5D), sleep quality (PSQI), diet (PDQS) and hip and knee pain (WOMAC). They 
collect their gummies for the full 12-week period. The gummies are divided into 12 packets (labelled 
with the participants unique, pseudonymised code), with each packet consisting of 14 gummies (for 
2 gummies x 7 days). On the first visit they will receive 6 packs (for the first 6 week, and on the 
second visit they will receive the remaining 6 packs) 
 
Visit 2 
On their pre-organized day and time, participants repeat the activities undertaken during visit 1. 
Second assessment of physical strength, finger dexterity, quality of life, sleep quality, diet choices, 
hip and knee pain, and week 6 urine drop off. On the second visit they will receive the remaining 6 
packs of supplements. 
 
 
Visit 3 
On their pre-organized day and time, participants repeat the same activities as undertaken during 
visits 1 and 2. Final assessment of physical strength, finger dexterity, quality of life, sleep quality, 
diet choices hip and knee pain and week 12 urine drop off. 
 
 

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
 
6) Participant Risks 
 
The supplements have been tested for any adverse effects, so no risks are anticipated. However, 
participants are informed that if any negative effects occur, then they should refrain from continuing 
in the study and to inform the research team. The urine kits contain a needle, so care should be 
taken. 
 
7) Benefits to participant 
There is no financial incentive for participants if they decide to join this study. They will be allowing 
the researchers gain important insight into the anti-inflammatory properties of the cucumber 
supplement and the digestion and metabolism of the supplement within urine. This will be the first 
time this type of research will have been conducted and will be a valuable pilot study before the 
researchers can investigate further human health benefits in the future.  
 
8) Ethical approval 
 
Aberystwyth University Research Ethics Panel confirmed a favourable ethical opinion subject on 
the 27th October 2022. 
 
9) Privacy/confidentiality 
Participants are informed that only the researchers involved with the study will be able to look at the 
information they provide. Specific details and personal identifiers will only be available to the 
researchers. At the end of the study, any information relating to participants will be made 
pseudonymous (coded without their name associated).  Participants will not be identifiable in any 
publication that may arise from this research. Electronic files will be kept in a logical manner and 
will always be kept grouped within specific folders and password protected, and backed up. There 
may be times when keeping paper forms are necessary (consent forms), but in this case the paper 
versions will be kept in a locked filing cabinet. All biofluids are stored in a locked freezer. Key is 
kept by the gatekeeper. 
 
This research is being conducted in accordance with the GDPR guidelines. The AU Data Protection 
Manager provides oversight of AU activities involving the processing of UK GDPR and special 
category data, and can be contacted at infocompliance@aber.ac.uk. Personal data will be stored 
securely and processed for metabolomic analysis. The legal basis that would be used to process 
personal data will be ‘a task in the public interest’. If participants are concerned about how personal 
data is being processed, AU can be contacted in the first instance at infocompliance@aber.ac.uk. If 
they remain dissatisfied, they may wish to contact the Information Commissioner’s Office (ICO). 
Contact details, and details of data subject rights, are available on the ICO website at: 
https://ico.org.uk/for-organisations/data-protection-reform/overview-of-the-gdpr/individuals-rights/.  
 
 
 
10) Safety Monitoring 
Participant: 
If a participant, or a member of their family/household become unwell during the study, then they are 
pre-warned to alert a member of the research team immediately using the contact information they  

                                                            
 
GDPR:  For the data the Welsh Government requires, Welsh Government is the data controller and Aberystwyth 
University (WARU) is the data processor.  For any other data, including sensitive personal data, the data controller and 
the data processor is Aberystwyth University (WARU). 
 
have been provided. Participation in the study will be suspended immediately until further discussion 
with the research team has taken place. If they become unwell at any point and need medical 
assistance, they are advised to contact 111 and seek advice from the NHS health sector or their 
doctor’s surgery. We have a duty of care towards them and can help monitor their health remotely 
over 14 days and will help in any way we can.  
 
Data:  
See Privacy/confidentiality 
 
In exceptional circumstances, confidentiality may have to be breached in cases where persons are 
considered to be at risk or if required by law.  
11) Data analysis and statistics 
The chemical composition of urine samples will be assessed at AberInnovation and Aberystwyth 
University using high resolution metabolomics. Self-report data will be analysed in WARU using 
appropriate methods. 
 
12) Sponsors and contacts 
 
Welsh Government is the sponsor. Gateway Health Alliances, Inc and Phytoquest are the companies. 
Main contact is Amanda Lloyd, Aberystwyth University abl@aber.ac.uk