NCT05372900已完成不适用
Nutritional Intervention to Improve Sleep Quality and Improve Next-day Mood and Cognitive Benefits
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年3月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Changes in sleep efficiency (actigraphy)
研究概览
简要总结
The study aim to test the effect of a meal complement to be taken in combination with an evening meal with a glycemic load of 55, to improve sleep quality.
详细描述
Considering emerging evidence on the role of the macro and micro-nutrient composition of evening meals, the intervention used in this study will be designed to provide the necessary nutrients to promote sleep quality. The IP will be a low caloric nutritional solution, combining:
- Ingredients lowering glycemic response to evening meals to promote sleep quality
- a protein source rich in bioavailable tryptophan to promote sleep quality
- supporting ingredients contributing to sleep initiation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able provide written informed consent (in English)
- •BMI range from 18.5 to 24.9 kg/m2
- •Subjective sleep complaints (PSQI > 5)
排除标准
- •Diagnosed food allergy or other intolerance to the investigational products, control products and standardized meals
- •Significant past medical and psychiatric history and ongoing chronic conditions for example cardiovascular disease, respiratory disease, metabolic disorder, endocrine disorder (e.g. diabetes mellitus, history of hypoglycemia), and neurological and psychiatric conditions, and conditions that the investigator deem inappropriate to enter the clinical trials
- •Significant medication history including use of corticosteroid in oral or systemic format and antidepressants (e.g. Selective Serotonin Reuptake Inhibitors, Monoamine Oxidase Inhibitors)
- •Pregnant or intending to conceive during the course of clinical trial and up to one month after trial conclusion, or not able to comply with a highly effective form of birth control or lactating during the clinical trial. Highly effective contraception includes hormonal methods, such as the contraceptive pill or implant, or an intrauterine device (IUD), or barrier methods such as diaphragm plus spermicide or condom plus spermicide. Pregnancy status will be assessed using urinary dipsticks at the beginning and end of the study period (V0 and V9).
- •Parents of children less than 12 months of age, which is a known factor of sleep disturbances.
- •Peri- and post-menopausal women
- •Known or diagnosed sleep disorders
- •Special diets, including for instance halal food preference, vegetarian, high protein or weight loss program, and diets with either too low (< 35% daily energy from CHO; e.g., ketogenic diet, Atkins diet, zero-carb diet, low-carb paleo/Mediterranean diet, carb cycling diet) or too high carbohydrate (>70% daily energy from CHO) content .
- •Chronic exercisers, defined as subjects exercising > 1 h/day for at least 5 days/week
- •Caffeine consumption over the recommended daily limit (above 400 mg; equivalent to approximately 4-5 cups of coffee)
- •Substance abuse including over the limit alcohol consumption (2 standard drinks/day for males, 1 standard drink/day for female)
- •Cigarette and Tobacco Smokers
- •Intake of dietary supplements that may affect sleep conditions (e.g. melatonin, theanine, tryptophan, GABA, magnesium, zinc)
- •Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
- •Participating in other clinical trials or had been participating in other clinical trial in the preceding 1 month.
- •Subjects belonging to a household where at least one other person is taking part in the trial.
结局指标
主要结局
Changes in sleep efficiency (actigraphy)
时间窗: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
Calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good.
Change in sleep latency (actigraphy)
时间窗: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
Measured as the amount of time it takes subjects to fall asleep after going to bed (in minutes)
次要结局
- Changes in self-reported sleep quality via KSD(Day 1 (V1), Day 15 (V2), Day 22 (V3), Day 23, Day 24 (V4) to Day 37, Day 45 and 65, Day 66 (V7) to Day 79, Day 87 (V9))
- Cognition task PVT(Day 22 (V3), Day 23, 31, 37, 65, 73, 79)
- Cognition task NASA-TLX(Day 22 (V3), Day 23, 31, 37, 65, 73, 79)
- Changes in self-reported sleep quality via Actigraphy(Day 1 (V1) to Day 15 (V2) , Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9))
- Changes in self-reported sleep quality via ESS(Day 1 (V1) & Day 15 (V2), Day 23, 31, 37, 45, 65, 73, 79, 87))
- Mood states, alertness, and sleepiness via KSS(Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79)
- Mood states, alertness, and sleepiness via BMIS(Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79)
- Cognition test Go/No-Go task(Day 22 (V3), Day 23, 31, 37, 65, 73, 79)
- Glycemia(Day 1 (V1) to Day 14, Day 24 (V4) to Day 37, Day 66 (V7) 7 to Day 79)
- Cognition tasks via Immediate & delayed free recall(Day 22 (V3), Day 23, 37, 65, 79)
- Mood states, alertness, and sleepiness via POMS-SF 2(Day 22 (V3), Day 23, 31, 37, 65, 73, 79)
- Cognition test N-back task(Day 22 (V3), Day 23, 31, 37, 65, 73, 79)
研究者
研究点 (2)
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