Oral Supplement in Older Adults to Support Physical Fitness and Mental Well-being
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Finger dexterity measurements
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Triple blinded
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Finger dexterity measurements
时间窗: Change from baseline Finger dexterity at 12 weeks
Nine-Hole Peg Test (9HPT)
Physical strength
时间窗: Change from Baseline grip strength at 12 weeks
Hand grip strength using a hand held dynamometer
次要结局
- Record sleeping habits(Decreased score from baseline Pittsburgh Sleep Quality Index at 12 weeks)
- Diet choices(Increased score from baseline Prime Diet Quality Score at 12 weeks)
- EuroQol 5 Dimension 5L (combined score)(Reduced score from baseline EuroQol 5 Dimension 5 score at 12 weeks.)