Osteo-arthritisPhase 1PQQANCT05878847
Oral Supplement in Older Adults to Support Physical Fitness and Mental Well-being
A Phase 1 study testing Q-actin in people with Osteo-arthritis, run by Aberystwyth University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo-arthritis
- What is being tested?
- Q-actin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Apr 2023to 22 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Well-being and Health Assessment Research Unit (WARU)
Aberystwyth, Ceredigion, SY23 3FD
Amanda J Lloyd, PhD, BSc, 07811618109, abl@aber.ac.uk
Alina Warren, Ms, BSc, 07539440811, arw21@aber.ac.uk
About this study
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.
Read the 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.
- Conditions
- Osteo-arthritis
- Being tested
- Q-actin, Placebo
- Keywords
- Older adults, Mental well-being, Physical fitness, Sleep quality
- Medical subject headings
- Psychological Well-Being, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-actinDietary supplement
Also called idoBR1
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.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Q-actin | Experimental | Q-actin gummies (2 x 10mg) daily for 12 weeks Receives: Dietary Supplement: Q-actin |
| Placebo | Placebo comparator | Placebo gummies (2 x 10mg) daily for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical strength
Hand grip strength using a hand held dynamometer
Measured: Change from Baseline grip strength at 12 weeks
Finger dexterity measurements
Nine-Hole Peg Test (9HPT)
Measured: Change from baseline Finger dexterity at 12 weeks
Secondary outcomes (3)
EuroQol 5 Dimension 5L (combined score)
EuroQol 5 Dimension 5 5L questionnaire: Generic quality of life. Mobility- Level 1-5 Self-Care- Level 1-5, Usual Activities- Level 1-5, Pain/Discomfort- Level 1-5, Anxiety/Depression- Level 1-5. The digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state.
Measured: Reduced score from baseline EuroQol 5 Dimension 5 score at 12 weeks.
Diet choices
Measured using the Prime Diet Quality Score. The PDQS measures intake of the 22 component foods/food groups over the last 30 days with seven possible responses for each component ranging from "once a month or less" to "≥ 2 times/day." Scores are then summed to create a PDQS total diet quality score with a possible score from 0 to 126 with higher scores indicating a healthier diet.
Measured: Increased score from baseline Prime Diet Quality Score at 12 weeks
Record sleeping habits
Pittsburgh Sleep Quality Index Component 1: Subjective sleep quality-question 9 Component 2: Sleep latency-questions 2 and 5a Component 3: Sleep duration-question 4 Component 4: Sleep efficiency-questions 1, 3, and 4 Component 5: Sleep disturbance-questions 5b-5j Component 6: Use of sleep medication-question 6 Component 7: Daytime dysfunction-questions 7 and 8 Global PSQI Score: Sum of seven component scores
Measured: Decreased score from baseline Pittsburgh Sleep Quality Index at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start22 Apr 2023
- Primary completion22 Dec 2023 (estimated)
- Study completion22 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo-arthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aberystwyth University
- Sponsor type
- University, hospital or other
- Collaborators
- Phytoquest Ltd, Gateway Health Alliances, Inc, Welsh Government
- Responsible party
- Sponsor
- Investigators
- Amanda Jane J Lloyd, PhD, BSc, Principal investigator, Aberystwyth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878847
- Sponsor's protocol ID
- 23767
- Other IDs
- PQQA
- Acronym
- PQQA
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) will not be made available to other researchers.
Publications
Lloyd AJ, Nash RJ, Warren-Walker A, Watson A, Martinez Martin MP, Davies C, Villarreal-Ramos B, Wilson T, Beckmann M. Oral supplement in healthy older adults to support physical fitness and mental wellbeing. Front Nutr. 2025 May 12;12:1563999. doi: 10.3389/fnut.2025.1563999. eCollection 2025.
PubMed 40421033
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Supplement in Older Adults to Support Physical Fitness and Mental Well-being
- ClinicalTrials.gov ID
- NCT05878847
- Acronym / sponsor ID
- PQQA / 23767
- Conditions
- Osteo-arthritis
- Keywords
- Older adults, Mental well-being, Physical fitness, Sleep quality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aberystwyth UniversityUniversity, hospital or other
- Collaborators
- Phytoquest Ltd, Gateway Health Alliances, Inc, Welsh Government
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 22 Dec 2023 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Q-actin | Experimental | Dietary Supplement: Q-actinQ-actin gummies (2 x 10mg) daily for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo gummies (2 x 10mg) daily for 12 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-actinAlso: idoBR1idoBR1 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. | Dietary supplement | Q-actin |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Physical strength
Time frame: Change from Baseline grip strength at 12 weeks
Hand grip strength using a hand held dynamometer
Finger dexterity measurements
Time frame: Change from baseline Finger dexterity at 12 weeks
Nine-Hole Peg Test (9HPT)
3 secondary outcomes
EuroQol 5 Dimension 5L (combined score)
Time frame: Reduced score from baseline EuroQol 5 Dimension 5 score at 12 weeks.
Diet choices
Time frame: Increased score from baseline Prime Diet Quality Score at 12 weeks
Record sleeping habits
Time frame: Decreased score from baseline Pittsburgh Sleep Quality Index at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Derived from this study: PubMed 40421033Lloyd AJ, Nash RJ, Warren-Walker A, Watson A, Martinez Martin MP, Davies C, Villarreal-Ramos B, Wilson T, Beckmann M. Oral supplement in healthy older adults to support physical fitness and mental wellbeing. Front Nutr. 2025 May 12;12:1563999. doi: 10.3389/fnut.2025.1563999. eCollection 2025.
- Individual participant dataSharing planned: No. individual participant data (IPD) will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Jane J Lloyd, PhD, BSc principal investigator
Aberystwyth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Q-actin in people with Osteo-arthritis, run by Aberystwyth University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda J Lloyd, PhD, BSc (07811618109, abl@aber.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical strength (time frame: Change from Baseline grip strength at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.