Clinical trial NCT05878847: Oral Supplement in Older Adults to Support Physical Fitness and Mental Well-being
Official title: Oral Supplement in Older Adults to Support Physical Fitness and Mental Well-being
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteo-arthritis
Keywords: Older adults
Mental well-being
Physical fitness
Sleep quality
Lead sponsor: Aberystwyth University
Sponsor class: OTHER
Collaborators: name: Phytoquest Ltd
name: Gateway Health Alliances, Inc
name: Welsh Government
First posted: 2023-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is split into three experimental sessions where you 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
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 osteo-arthritis from oral use.

The investigators are aiming to recruit a cohort (n = 50) of middle aged and older adults (\>50 years) who will be randomised into Q-actin (2 x 10 mg gummies daily) or placebo (2 x 10 mg gummies daily) supplementation for 12 weeks. Using hand grip strength and the Nine-Hole Peg Test (9HPT) the investigators will measure physical strength and finger dexterity respectively. The investigators will measure generic quality of life with the EuroQol 5 Dimension 5 (EQ-5D) questionnaire, sleep quality, diet choices and collect urine samples for the investigation into the chemical composition (metabolomics).

Randomisation will be blinded, and the participant and the researcher will not know what group participants in until after the completion of the study, then it will be disclosed.

Detailed description: 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 investigators would like to 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 (EuroQol 5 Dimension 5: EQ-5D questionnaire), sleep quality (Pittsburgh Sleep Quality Index), and diet (diet questionnaires are tailored to the participants eating habits, e.g., carnivore, vegetarian, fish, vegan etc). The investigators will explore urine chemical composition use high resolution metabolomics do this by looking at the chemical composition of home-collected urine.

After pre-induction over the phone, if the person is eligible and still interested, the investigators will firstly run through an induction session. This can be done by phone, 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 bed-time. 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. The investigators 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. The investigators would like participants to restrict from consumption of cucumber, gherkins, and melon for two days before coming to the centre.

Whilst undergoing the study, if necessary, the research team will be easily contacted by email, Teams and phone.

The visits

Tea, coffee and biscuits will be provided at each visit. Each visit will take up to an hour

Induction

First, the participant will be welcomed with tea or coffee. The investigators will run through how the investigators are working safely during coronavirus (COVID-19). Then the investigators 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 investigators will run through the logistics of study visits and the tasks that will be completed.

The investigators will also email the participant a link to the EQ-5D questionnaire, Pittsburgh Sleep Quality Index, and diet questionnaire, or give them a paper copy, so that they can complete these in the centre or at home (whatever is preferred).

The investigators will arrange the participants testing day 1, 2 and 3 visit dates and times.

Testing day 1 (start)

On the participants pre-organised day and time, will will ask them to collect 2 x 4ml first urine sample at home using home-collection urine kits. These samples will be stored in the participants home home fridge between 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. Will will ask them to make sure they complete their EQ-5D, Pittsburgh Sleep Quality Index, and diet questionnaire before they start their supplementation.

Testing day 2 (after 6 weeks)

After the 6-week supplementation period the investigators would like the participant to complete the activities that they undertook during testing day 1.

On their pre-organised day and time, will will ask them to collect 2 x 4ml first urine sample at home using home-collection urine kits. The investigators 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 investigators will ask the participant to make sure they complete their EQ-5D, Pittsburgh Sleep Quality index, and diet questionnaire before or just after testing day 2.

Testing day 3 (after 12 weeks)

After the 12-week supplementation period the investigators would like the participant to complete the activities that they undertook during testing day 1.

On their pre-organised day and time, will will ask them to collect 2 x 4ml first urine sample at home using home-collection urine kits. The investigators 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 investigators will ask the participant to make sure they complete their EQ-5D, Pittsburgh Sleep Quality index, and diet questionnaire before or just after testing day 3.

There will also be an optional feedback questionnaire at the end.

Eligibility criteria: Inclusion Criteria:

* over 50 years, mixed gender, mixed ethnicity
* 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, diet choices, sleep 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

Primary outcomes:
measure: Physical strength
timeFrame: Change from Baseline grip strength at 12 weeks
measure: Finger dexterity measurements
timeFrame: Change from baseline Finger dexterity at 12 weeks
Secondary outcomes:
measure: EuroQol 5 Dimension 5L (combined score)
timeFrame: Reduced score from baseline EuroQol 5 Dimension 5 score at 12 weeks.
measure: Diet choices
timeFrame: Increased score from baseline Prime Diet Quality Score at 12 weeks
measure: Record sleeping habits
timeFrame: Decreased score from baseline Pittsburgh Sleep Quality Index at 12 weeks
Other outcomes:
Locations:
city: Aberystwyth
country: United Kingdom
facility: Well-being and Health Assessment Research Unit (WARU)
state: Ceredigion
Study officials:
affiliation: Aberystwyth University
name: Amanda Jane J Lloyd, PhD, BSc
role: PRINCIPAL_INVESTIGATOR
References: