Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study B)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Difference in sleep onset latency (SOL) compared to placebo
研究概览
简要总结
single-center, randomized, cross over, double-blind, placebo controlled intervention study
详细描述
The single-center, randomized, cross over, double-blind, placebo controlled intervention study will include 70 subjects who will test the efficacy of three formulations on sleep quality parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject Informed consent form (ICF) is signed
- •aged 24-65 years at the time of the signature of ICF
- •suboptimal sleep quality according to Pittsburgh Sleep Quality Index (PSQI-SI): PSQI > 5
- •no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI <= 9
- •a body mass index (BMI) <= 32 kg/m2
- •stable medications for non excluded concurrent medical conditions for six weeks prior to the screening visit
- •ability to ingest oral food supplement (study product)
- •willing to follow all study procedures, including attending all site visits and use of actigraphy
排除标准
- •diagnosed or subject to therapy due to sleep disorders
- •acute infectious disease
- •any kind of chronic pharmacological therapy with antihypertensives or antidepressants
- •any kind of other pharmacological therapy that could interact with active ingredients used in the study
- •pregnancy or planned pregnancy, lactation, menopause (with pharmacological treatment)
- •use of beta-blockers
- •chronic use of use of prostaglandin synthesis inhibitors (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen
- •supplementation with melatonin or other food supplements intendent for sleep quality during last 2 weeks
- •unwillingness to maintain caffeine abstinence after 4:00 PM during the study
- •not having a mobile upper extremity for attaching an actigraph
- •known alcohol and/or drug abuse
- •unwillingness to comply with the maximum limit of 2 alcoholic drinks per day, and only up to 1 alcoholic drink after 6:00 PM during the study
- •known lactose/gluten intolerances/food allergies
- •known gastrointestinal disease
- •less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)
- •have stomach or bowel resection
- •night work or work shifts with night work
- •mental incapacity that precludes adequate understanding or cooperation
- •participation in another investigational study
研究组 & 干预措施
Active control (AC)
Active ingredient: 0.3 mg of melatonin per dosage. Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.
干预措施: 21 days of intervention with Active Control (AC) (Dietary Supplement)
Test product (TP)
Active ingredient: 480 mg of standardised dry hydroalcoholic extract Valeriana officinalis L., radix (Valerian root) [Ph. Eur. 1898] Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.
干预措施: 21 days of intervention with Test Product (TP) (Dietary Supplement)
Placebo product (PP)
Active ingredient: none. Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.
干预措施: 21 days of intervention with Placebo Product (PP) (Dietary Supplement)
结局指标
主要结局
Difference in sleep onset latency (SOL) compared to placebo
时间窗: 2 weeks
Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy.
Difference in sleep quality compared to placebo
时间窗: 2 weeks
Difference in sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI; ranking from 0 \[best\] to 21 \[worst\])
次要结局
- Difference in sleep efficiency (SE) compared to placebo(2 weeks)
研究者
Igor Pravst
Prof. Dr. Igor Pravst
Institute of Nutrition, Slovenia (Nutris)