Oral supplement in older adults to support physical fitness and mental well-being

ISRCTN	ISRCTN28705061
DOI	https://doi.org/10.1186/ISRCTN28705061
Secondary identifying numbers	23767

Submission date: 21/04/2023
Registration date: 21/04/2023
Last edited: 27/04/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Cucumbers have been anecdotally claimed to have anti-inflammatory activity for a long time, but the active principle was not identified. idoBR1 is an iminosugar amino acid isolated from fruits of certain cucumbers, Cucumis sativus (Cucurbitaceae), which has been shown to have anti-inflammatory activity. IminoTech Inc in the USA has produced a quality-controlled cucumber extract containing measured idoBR1 (Q-actin™) that has given good results in osteoarthritis from oral use. The aim of this study is to test if Q-actin will improve physical strength and finger dexterity when compared with placebo (and baseline) supplementation for 12 weeks. Quality of life, sleep quality, diet choices, knee and hip osteoarthritis and chemical composition of urine samples will also be measured.

Who can participate?
Healthy volunteers aged over 50 years

What does the study involve?
After pre-induction over the phone, eligible and interested participants will attend an induction session. This can be done by phone, Microsoft Teams or in person. The study is split into three experimental sessions where participants are randomly allocated to one of two supplements, Q-actin (2 x 10 mg gummies daily) or placebo (2 x 10 mg gummies daily) supplementation for 12 weeks. The vegan gummies will need to be consumed in the evening, before bedtime. Participants will need to come to the Well-being and Health Assessment Research Unit (WARU) or the remote centre for physical strength and finger dexterity measurements. The researchers will measure their quality of life and knee and hip osteoarthritis with a questionnaire, record diet choices, record sleeping habits, and collect urine samples before and after the supplementation period (at 0, 6 and 12 weeks). Participants should avoid eating cucumber, gherkins, and melon for 2 days before coming to WARU or the remote centre.

What are the possible benefits and risks of participating?
There is no financial gain for participants. This study will allow the researchers to gain important insight into the inflammatory properties of the cucumber supplement and the digestion and metabolism of the supplement in 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. The supplements have been tested for any adverse effects, but if any negative effects occur, participants can leave the study.

Where is the study run from?
Well-being and Health Assessment Research Unit (WARU) and a remote centre in Trimsaran, Wales (UK)

When is the study starting and how long is it expected to run for?
May 2022 to December 2023

Who is funding the study?
Welsh Government (UK)

Who is the main contact?
Amanda J Lloyd, abl@aber.ac.uk

Contact information

Dr Amanda Jane Lloyd
Principal Investigator

Aberystwyth University
Department of Life Sciences
Edward Llwyd Building
Aberystwyth
SY23 3DA
United Kingdom

ORCID ID	0000-0002-0775-3537
Phone	+44 (0)7811618109
Email	abl@aber.ac.uk

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community, Home, University/medical school/dental school
Study type	Prevention
Participant information sheet	43533_PIS.pdf
Scientific title	Oral supplement Q-actin in older adults to support physical fitness and mental well-being
Study acronym	PQQA
Study hypothesis	Q-actin (2 x 10 mg gummies daily) when compared with placebo (2 x 10 mg gummies daily) supplementation for 12 weeks will improve physical strength and finger dexterity (measured by hand grip strength and the Nine-Hole Peg Test (9HPT) respectively). Additionally, generic quality of life, sleep quality, diet choices and chemical composition of urine samples will improve in the intervention arm compared with baseline and placebo.
Ethics approval(s)	Approved 27/10/2022, Aberystwyth University Research Ethics Panel (Aberystwyth University, Reception, Penglais, Aberystwyth, Ceredigion, SY23 3FL, UK; +44 (0) 1970 621694; lif1@aber.ac.uk), ref: 23767
Condition	Osteoarthritis
Intervention	Cucumbers have been anecdotally claimed to have anti-inflammatory activity for a long time, but the active principle was not identified. idoBR1 is an iminosugar amino acid isolated from fruits of certain cucumbers, Cucumis sativus (Cucurbitaceae), which has been shown to have anti-inflammatory activity. The researchers would like to explore if the 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), knee and hip osteoarthritis (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), and diet (diet questionnaires are tailored to your eating habits, e.g., carnivore, vegetarian, fish, vegan etc). The researchers will explore urine chemical composition using high-resolution metabolomics of home-collected urine. After pre-induction over the phone, if the person is eligible and still interested, the researchers will first run through an induction session. This can be done by phone, Microsoft Teams or in person, whatever suits best. The study is split into three experimental sessions where the participant will be randomised to one of two supplements, Q-actin (2 x 10 mg gummies daily) or placebo (2 x 10 mg gummies daily) supplementation for 12 weeks. The vegan gummies will need to be consumed in the evening, before bedtime. Randomisation will be blinded, and the participant and the researcher will not know what group they in until after the completion of the study. The participant will need to come to the centre for physical strength and finger dexterity measurements using hand grip strength and the Nine-Hole Peg Test (9HPT) respectively. Knee and hip osteoarthritis will be assessed using the WOMAC questionnaire. The researchers will measure generic quality of life with the EQ-5D questionnaire, record diet choices, record sleeping habits using the Pittsburgh Sleep Quality Index, and collect urine samples before and after the supplementation period. They would like participants to restrict from consumption of cucumber, gherkins, and melon for 2 days before coming to the centre. Whilst undergoing the study, if necessary, the research team will be easily contacted by email, Microsoft Teams and phone. The visits: Tea, coffee and biscuits will be provided at each visit. Each visit will take up to 1 hour Induction: First, the participant will be welcomed with tea or coffee. The researchers will run through how we are working safely during coronavirus (COVID-19). Then we will introduce the participant to the urine sampling boxes, provide crib sheets and email the participant with a link to a video demonstration, if needed. The researchers will run through the logistics of study visits and the tasks that will be completed. The researchers will also email the participant a link to the EQ-5D questionnaire, Pittsburgh Sleep Quality Index, WOMAC questionnaire and diet questionnaire, or give them a paper copy, so that they can complete these in the centre or at home (whatever is preferred). They will arrange the participants testing day 1, 2 and 3 visit dates and times. Testing day 1 (start): On the participant's pre-organised day and time, the researchers will ask them to collect 2 x 4 ml first urine sample at home using home-collection urine kits. These samples will be stored in the participant's home fridge at 2-5 degrees. The participant will then come to the centre at a pre-organised timeslot with their urine samples for physical strength and finger dexterity activities. The researchers will ask them to make sure they complete their EQ-5D, Pittsburgh Sleep Quality Index, WOMAC questionnaire and diet questionnaire before they start their supplementation. Testing day 2 (after 6 weeks): After the 6-week supplementation period the participant completes the activities that they undertook during testing day 1. On their pre-organised day and time, the researchers will ask them to collect 2 x 4 ml first urine sample at home using home-collection urine kits. The researchers will ask the participant to store these samples in their home fridge between 2-5 degrees. The participant will then come to the centre for their pre-organised timeslot with their urine samples for physical strength and finger dexterity activities. The researchers will ask the participant to make sure they complete their EQ-5D, Pittsburgh Sleep Quality Index, WOMAC questionnaire and diet questionnaire before or just after testing day 2. Testing day 3 (after 12 weeks) After the 12-week supplementation period the participant completes the activities that they undertook during testing day 1. On their pre-organised day and time, the researchers will ask them to collect 2 x 4 ml first urine sample at home using home-collection urine kits. The researchers will ask the participant to store these samples in their home fridge at 2-5 degrees. The participant will then come to the centre for their pre-organised timeslot with their urine samples for physical strength and finger dexterity activities. The researchers will ask the participant to make sure they complete their EQ-5D, Pittsburgh Sleep Quality Index, WOMAC questionnaire and diet questionnaire before or just after testing day 3. There will also be an optional feedback questionnaire at the end.
Intervention type	Supplement
Primary outcome measure	Physical strength measured using hand grip strength at 0, 6, and 12 weeks
Secondary outcome measures	1. Finger dexterity measured using Nine-Hole Peg Test (9HPT) at 0, 6, and 12 weeks 2. Generic quality of life measured using EQ-5D questionnaire at 0, 6, and 12 weeks 3. Diet choices measured using the Prime Diet Quality Score (PDQS) at 0, 6, and 12 weeks 4. Sleeping habits measured using the Pittsburgh Sleep Quality Index at 0, 6, and 12 weeks 5. Non-targeted metabolomics of urine samples at 0, 6 and 12 weeks Added 24/04/2023: 6. Knee and hip osteoarthritis assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at 0, 6, and 12 weeks
Overall study start date	16/05/2022
Overall study end date	31/12/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	50
Participant inclusion criteria	1. Aged over 50 years 2. Consent 3. Commit to urine sampling 4. Able to commit to attending WARU or the remote centre for measurements of physical strength, finger dexterity, quality of life, diet choices, and sleep 5. Able to restrict from consumption of cucumber, gherkins, and melon for 2 days before coming to WARU or the remote centre
Participant exclusion criteria	1. Showing (or anyone within the household) any COVID-19 symptoms (see COVID-19 basic health screen)* 2. Higher risk or vulnerable to coronavirus or live with someone at a higher risk of a severe illness from COVID-19 (aged over 70 years, undergoing cancer treatment, high risk of getting infections) 3. Had a letter from the NHS advising you to shield (isolate) 4. Had been at risk of exposure to COVID-19 such as travel, contact with someone with COVID-19, being exposed to the virus, or has been asked to self-isolate by the track and trace system 5. Serious health conditions that require daily long-term medication
Recruitment start date	12/12/2022
Recruitment end date	22/04/2023

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centres

Well-being and Health Assessment Research Unit (WARU)

Carwyn James Building
Penglais Campus
Aberystwyth
SY23 3FD
United Kingdom

Trimsaran Leisure Centre

Heol Llanelli
Trimsaran
SA17 4AA
United Kingdom

Sponsor information

Welsh Government
Government

Food Business Manager
Food Division
Llandudno Junction
Llandudno Junction
LL31 9RZ
Wales
United Kingdom

Phone	+44 (0)300 062 5139
Email	wendy.jones@gov.wales
Website	http://gov.wales/?skip=1&lang=en
"ROR"	https://ror.org/000wh6t45

Phytoquest Ltd
Industry

Phytoquest Ltd
Plas Gogerddan
Aberystwyth
SY23 3EB
Wales
United Kingdom

Phone	+44 (0)1970 823200
Email	robert.nash@phytoquest.co.uk
Website	http://phytoquest.co.uk/

Gateway Health Alliances, Inc
Industry

4769 Mangels Blvd
Fairfield
CA 94534
United States of America

Phone	+1 (0)707 688 7999
Email	shilkothari@hotmail.com
Website	https://www.ghainc.com/

Funders

Funder type

Government

Llywodraeth Cymru
Government organisation / Local government

Alternative name(s): Welsh Government, The Welsh Government
Location: United Kingdom

Results and Publications

Intention to publish date	01/09/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The researchers plan to disseminate in July 2023 and publish in September 2023
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request (Amanda Lloyd, abl@aber.ac.uk)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			21/04/2023	No	Yes

Additional files

43533_PIS.pdf

Editorial Notes

27/04/2023: Trial participating centre added.
21/04/2023: Trial's existence confirmed by the Aberystwyth University Research Ethics Panel.