Impact of Nutritional Supplementation on Gut-brain Axis in Older Adults With Normal Cognition vs. Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in sleep quality assessed by validated sleep questionnaires
研究概览
简要总结
The aim of this study is to assess the impact of 5-hydroxytryptophan (5-HTP) supplementation on sleep quality and gut microbiome composition in older adults with normal cognition vs. mild cognitive impairment (MCI) using a randomized controlled trial.
详细描述
This is a 12-wk parallel, single-bind (investigator), prospective study design with subjects randomly assigned to consume 100 mg of 5-HTP or does not consume 5-HTP. Fifty older men and women (aged 60-85y, approximately half men and half women, approximately half subjects with MCI) will be recruited with the expectation that ≥ 40 subjects (≥ 10 subjects per group) will complete the study. Body size, blood pressure, urinary melatonin, sleep quality, cognitive function and mood (including depression and anxiety), gut microbiome, and short chain fatty acids will be assessed. Blood amino acid concentration will be measured as an indicator of compliance to the 5-HTP consumption from the collected blood samples.
Relevance to Singapore: The results from the proposed research will assist a practical guidance of nutritional behavior changes providing gut and brain health promoting effects to Singapore older individuals with or without MCI and may result in reducing cost and manpower for cognitive decline care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (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
- •Able to give an informed consent
- •Age 60 ≤years ≤ 85 years old
- •Weight change < 3kg in the past 3 months
- •Not exercising vigorously over the past 3 months
- •Not taking protein (e.g. Whey isolate, Ensure), tryptophan, serotonin and/or 5-HTP supplements for the past one month
- •Not taking sleep medication and/or dietary supplements for sleep (e.g. melatonin, GABA) for the past one month
- •Not taking prebiotic, probiotic and/or dietary fiber supplementations for the past one month
- •Not taking cognitive/brain supplementations (e.g. gingko biloba, acetylcholine) for the past one month
- •Not taking prescription anti-depressant or pain medication (e.g. Zoloft, Tramadol etc.)
- •No acute illness
- •If taking antihypertensive/cholesterol-lowering/ type 2 diabetic medication, he/she has been taking the medication for more than 5 years prior to the study participation
- •Not smoking
- •Not drinking more than 2 alcoholic drinks per day
排除标准
- •Unable to give an informed consent
- •Age < 60 years and >85 years old
- •Weight change >3kg in the past 3 months
- •Exercises vigorously over the past 3 months
- •Taking protein (e.g. Whey isolate, Ensure), tryptophan, serotonin and/or 5-HTP supplements for the past one month
- •Taking sleep medication and/or dietary supplements for sleep (e.g. melatonin, GABA) for the past one month
- •Taking prebiotic, probiotic and/or dietary fiber supplementations for the past one month
- •Taking cognitive/brain supplementation (e.g. gingko biloba, acetylcholine) for the past one month
- •Taking prescription anti-depressant or pain medication (e.g. Zoloft, Tramadol etc.)
- •Having acute illness
- •If taking antihypertensive/cholesterol-lowering/ type 2 diabetic medication, he/she has NOT been taking the medication for less than 5 years prior to the study participation
- •Drinking more than 2 alcoholic drinks/day
研究组 & 干预措施
Normal subject without 5-HTP
Subjects with normal cognition will be randomly assigned to not consuming 5-HTP.
干预措施: Without 5-HTP (Other)
Normal subject with 5-HTP
Subjects with normal cognition will be randomly assigned to consuming 100 mg of 5-HTP.
干预措施: 5-HTP (Dietary Supplement)
结局指标
主要结局
Change in sleep quality assessed by validated sleep questionnaires
时间窗: Every 4 weeks (week 0, week 4, week 8 and week 12)
Pittsburgh Sleep Quality Index Questionnaire (PSQI) will be used to assess the sleep quality. Overall score ranging from 0 to 21 points, where lower scores denote a healthier sleep quality.
Change in sleep quality assessed by electronic equipment
时间窗: Every 4 weeks (week 0, week 4, week 8 and week 12)
An electronic equipment, actigraphy, will be used to assess the sleep quality, including sleep timing and wake up timing.
Change in fecal short chain fatty acid (SCFA) concentration as assessed by micromoles per gram (μmol/g)
时间窗: Pre- and post-intervention (week 0 and week 12)
Fecal SCFA concentration will be measured using gas chromatograph (GC) and assessed by μmol/g. There is no recognized range. Normally the higher level is better.
Change in fecal microbiome composition
时间窗: Pre- and post-intervention (week 0 and week 12)
High-throughput sequencing method (using Illumina MiSeq platforms) will be used to assess the changes in gut microbiome composition.
次要结局
- Change in weight and height(Every 4 weeks (week 0, week 4, week 8 and week 12))
- Change in Quality of Life: WHOQOL(Every 4 weeks (week 0, week 4, week 8 and week 12))
- Change in Cognitive function(Every 4 weeks (week 0, week 4, week 8 and week 12))
- Change in mood (depression)(Every 4 weeks (week 0, week 4, week 8 and week 12))
- Change in waist circumference as assessed by centimeter (cm)(Every 4 weeks (week 0, week 4, week 8 and week 12))
- Change in mood (anxiety)(Every 4 weeks (week 0, week 4, week 8 and week 12))
- Change in urinary melatonin levels as assessed by nanogram per milliliter (ng/mL)(Pre- and post-intervention (week 0 and week 12))
- Change in blood amino acids assessed by nanomole per milliliter (ng/mL)(Pre- and post-intervention (week 0 and week 12))
- Dietary assessment(Every 4 weeks (week 0, week 4, week 8 and week 12))
- Blood pressure as assessed by millimeter of mercury (mmHg)(Every 4 weeks (week 0, week 4, week 8 and week 12))
研究者
Jung Eun Kim
Assistant Professor
National University of Singapore