NCT04860050已完成不适用
A Double Blind, Parallel, Placebo-controlled, Randomised Clinical Trial to Evaluate the Efficacy of Turmipure Gold® to Improve Cognitive Performance in Healthy Aging.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 568
- 试验地点
- 2
- 主要终点
- Change in cognitive performance through Quality of Working memory
研究概览
简要总结
The objective of the study is to test the capacity of acute and chronic supplementations of Turmipure GOLD® to improve cognitive performance in healthy aging
详细描述
The aim of this clinical study is to determine whether oral administration of Turmipure GOLD® can contribute to the short- and long-term improvement of cognitive functions, including memory and attention, in subjects with age-associated memory impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consent to the study and willing/able to comply with study product
- •Males and females aged ≥ 60 and ≤ 85 years old
- •Participants with subjective memory impairment, with preserved global cognitive functions, everyday activities, and no dementia, fulfilling age-associated memory impairment criteria based on the following National Institute of Mental Health criteria (AAMI, Crook 1986):
- •Subjective memory complaint reflected in everyday difficulties (gradual) confirmed with a MAC-Q ≥25
- •Memory loss confirmed by a 1st degree relative or life-partner
- •Memory test performance that is at least 1SD below the mean established for healthy adults on a standardised test of secondary memory (VPA I and II portions of the Wechsler Memory Scale IV)
- •Evidence of adequate intellectual function as determined by the Vocabulary subset of the Wechsler Adult Intelligence Scale
- •Absence of dementia, as determined by the Telephone - Mini-Mental State Examination (MMSE) predicted in person score ≥24
- •Not suffering from depression or anxiety, as determined by the Hospital Anxiety and Depression Scale (HADs) score of ≤7 for both depression and anxiety
- •With a BMI between 18 and 32 kg/m²
- •With a glycated haemoglobin/A1C score ≤ 5.7 %
- •Willing to maintain existing dietary, body weight, and physical activity patterns throughout the study period
排除标准
- •Abnormal laboratory test results of clinical significance
- •With significant cardiovascular history, or significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives, as deemed exclusionary by the Principal Investigator
- •With history of major head trauma, chronic traumatic encephalopathy, epilepsy, cerebrovascular disease, stroke or clinically diagnosed with mild cognitive impairment or dementia (such as Alzheimer's Disease according to the NINCDS-ADRDA guidelines), acute psychiatric disorder, schizophrenia, mania, depression (within past 24 months) or under any concurrent medical, cognitive or psychiatric condition that would either: compromise his/her ability to comply with the study requirements, may pose significant risk to the subject, or be deemed exclusionary by the Principal Investigator
- •History of heavy smoking (> 1 pack/day) within past 3 months
- •History of heavy caffeinated beverage consumption (> 400 mg caffeine/day) within past 2 weeks
- •Taking any supplements or vitamins notably known to affect cognitive function (e.g. Living Nutrition Cognitive, Viridian Cognitive Complex, fish oil etc., list not exhaustive), or any psychotropic medications and products which interact with acetylcholine esterase and/or NMDA receptors (6-week washout before screening). Vitamin D and Calcium supplements permitted if on a stable dose for the previous 3 months
- •Participant with history of drug and/or alcohol abuse at the time of enrolment
- •Significant change of dietary habits within the preceding month
- •With known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon or significant systemic disease, and with history of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
- •Participant with known allergy to components of the test product or with a medical history of food allergies
- •Having uncontrolled hypertension, uncontrolled hypothyroidism or hyperthyroidism or uncontrolled lipidaemia (hypercholesteremia or hypertriglyceridemia) that is not on stable medication for at least 3 months.
- •Current illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation/severe, difficulty swallowing)
- •Participants taking any anticoagulant (including aspirin) or heparin treatment
- •Participant currently involved in any other clinical trial or having participated in a trial within the preceding 90 days
- •Individuals who are unable to give informed consent
- •Participant has a history of non-compliance with medical treatments or recommendations
- •Occupations that resulted in disruption of sleep-wake cycles
- •Participant has difficulty hearing with or without a hearing aid or is colour blind or is visually impaired
结局指标
主要结局
Change in cognitive performance through Quality of Working memory
时间窗: 24 weeks
Quality of Working memory is a composite score determined by the CDR System™ test battery (unit: #)
次要结局
- Change in cognitive performance through Executive Function(24 weeks)
- Change in mood(24 weeks)
- Change in cognitive performance through Speed of Memory(24 weeks)
- Change in cognitive performance through Quality of Episodic Memory(24 weeks)
- Change in feelings and emotions(24 weeks)
- Change in cognitive performance through Power of Attention(24 weeks)
- Change in cognitive performance through Cognitive Reaction Time(24 weeks)
- Change in stress(24 weeks)
- Change in cognitive performance through Continuity of Attention(24 weeks)
- Change in cognitive performance through Quality of Memory(24 weeks)
研究者
研究点 (2)
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