Oral Supplement in Older Adults to Support Physical Fitness and Mental Well-being

NCT05878847 | Unknown Phase 1

• 2 other identifiers: 23767PQQA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo-arthritis

Keywords

Older adults; Mental well-being; Physical fitness; Sleep quality

Outcome Measures

Primary Outcomes (2)

• Physical strength

  Hand grip strength using a hand held dynamometer

  Change from Baseline grip strength at 12 weeks

• Finger dexterity measurements

  Nine-Hole Peg Test (9HPT)

  Change from baseline Finger dexterity at 12 weeks

Secondary Outcomes (3)

• EuroQol 5 Dimension 5L (combined score)

  Reduced score from baseline EuroQol 5 Dimension 5 score at 12 weeks.

• Diet choices

  Increased score from baseline Prime Diet Quality Score at 12 weeks

• Record sleeping habits

  Decreased score from baseline Pittsburgh Sleep Quality Index at 12 weeks

Study Arms (2)

Q-actin

EXPERIMENTAL

Q-actin gummies (2 x 10mg) daily for 12 weeks

Dietary Supplement: Q-actin

Placebo

PLACEBO COMPARATOR

Placebo gummies (2 x 10mg) daily for 12 weeks

Dietary Supplement: Placebo

Interventions

Q-actin DIETARY_SUPPLEMENT

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.

Also known as: idoBR1

Q-actin

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aberystwyth University: lead
• Phytoquest Ltd: collaborator
• Gateway Health Alliances, Inc: collaborator
• Welsh Government: collaborator

Study Sites (1)

Well-being and Health Assessment Research Unit (WARU)

Aberystwyth, Ceredigion, SY23 3FD, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 40421033 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Amanda Jane J Lloyd, PhD, BSc

  Aberystwyth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda J Lloyd, PhD, BSc

CONTACT

07811618109; abl@aber.ac.uk

Alina Warren, Ms, BSc

CONTACT

07539440811; arw21@aber.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 26, 2023
• Study Start: April 22, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)