Effects of a Novel Melatonin and Magnesium-Containing Pod on Sleep, Metabolism, Body Composition and Performance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Biochemical sleep marker - Change in salivary melatonin
研究概览
简要总结
This study aimed to investigate the effects of a novel dietary supplement, consisting of melatonin and magnesium in a pod (coffee machine capsule) format, on sleep quality, stress, mood, sleepiness, biological rhythms, metabolism, body composition and performance, in individuals with sleep disturbances according with the Pittsburgh Sleep Quality Index. A randomized, double-blind, crossover trial will be conducted to compare the effects of the melatonin and magnesium-containing supplement against a placebo. The protocol comprises 4 weeks of supplementation with an experimental or placebo condition, with a week-long washout period. Biochemical markers of sleep and stress, actigraphy for sleep patterns and sleep hygiene, resting metabolic rate, food and fluid intake, body composition, and handgrip strength measures will be evaluated at baseline and 4 weeks post each randomly assigned intervention. The working hypothesis is that this innovative supplement will provide greater objective and subjective improvements regarding sleep patterns and quality, overall mood, biochemical markers of stress, resting metabolic rate, energy intake, body composition and strength, than the placebo comparator, due to the synergic effects of melatonin and magnesium.
详细描述
A randomized, double-blind, crossover design will be used to investigate the efficacy of a novel developed melatonin and magnesium supplement in pod (coffee machine capsule) format on sleep patterns and sleep quality, mood, sleepiness, biological rhythms, stress, metabolism, body composition and strength performance. Prior to the intervention, participants will be screened for inclusion and exclusion criteria, namely presenting with sleep disturbs according to Pittsburgh Sleep Quality Index (score >5), not working in shifts, not experiencing jet lag frequently (e.g., flight personnel), nor taking medication which could interfere with sleep. A total of 35 individuals suffering from sleep disturbs will engage in 4 weeks of supplementation with melatonin and magnesium or placebo, separated by 1 week of washout, after which the second experimental condition will be conducted (4 weeks placebo or supplementation with melatonin and magnesium). At baseline and 4 weeks post each, randomly assigned intervention, participants will experience measurements of resting metabolic rate, body composition and strength, as well as the collection of saliva to measure melatonin and cortisol. Validated questionnaires on sleep quality, mood, sleepiness, and biological rhythms will also be applied and nutritional intake will be quantified and assessed for frequency and timing on the three occasions. Throughout the 8 weeks of supplementation, participants will use an actigraphy device continuously to evaluate sleep and awaken motor activity, and compliance to the assigned intervention will be confirmed in each visit to the laboratories.
In order to achieve the main goal of the study, assessments will take place in the morning (starting at 7:00 a.m.), after an overnight fast. Wearing minimal clothing and no shoes, participants will be weighed on a scale and have their height measured on a stadiometer (Seca, Hamburg, Germany). Body composition, namely bone mineral content, fat mass and fat free mass, will be assessed by dual energy X-ray absorptiometry (DXA) (Horizon Wi, Hologic, Waltham, USA). Total body water and its intra and extracellular compartments will be estimated from whole body resistance (R) and reactance (Xc), measured through bioelectrical impedance analysis (BIA), using a single frequency device of 50 kHz (BIA-101, RJL/Akern Systems, Firenze, Italy). From the raw R and Xc data, the phase angle will additionally be determined, using the Akern Software.
Resting metabolic rate (RMR) will be measured by indirect calorimetry, using a canopy ventilated open-circuit system (Quark, Cosmed, Italy). Participants will arrive to the laboratory in an overnight-fasted state, having refrained from exercise, caffeine, and alcohol consumption in the 12h before assessments. The equipment will be calibrated daily according to standard procedures. Participants will rest in supine position prior to the start of the measurement. Data will be collected for ≥15min with the first 5min being dismissed, according to protocol. The average resting metabolic rate will be considered the period of 5min of the test with lower coefficient of variance.
The handgrip strength test will be used to evaluate the maximal isometric force of the muscles of the hand and forearm. Using a portable hand dynamometer (JAMAR, Sammons Preston, Bolingbrook, IL, USA), participants will be tested for both hands alternately, in a stand-up position. The maximal force generated out of 3 attempts will be considered for analysis.
For biochemical markers, saliva will be collected in salivettes. Saliva will be used to measure melatonin and cortisol using Enzyme-Linked Immunosorbent Assay (ELISA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pittsburgh Sleep Quality Index >5 as an indicator of sleep disturbance.
排除标准
- •Taking medication which interferes with sleep;
- •Shift workers;
- •Workers who may experience jet lag (e.g. flight personnel).
结局指标
主要结局
Biochemical sleep marker - Change in salivary melatonin
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Salivary melatonin (pg/mL) will be assessed by enzyme-linked immunosorbent assay (ELISA)
Sleep parameter - Change in sleep quality
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Change in sleep quality (Pittsburgh Sleep Quality Index (PSQI) score) will be assessed by the validated Portuguese version of the PSQI. The PSQI global score, results from the sum of 7 component scores (0-3) and has a possible range of 0-21 points. A global PSQI score ≤ 5 identifies a good sleeper and \>5 a poor sleeper.
Sleep parameter - Change in mood states
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Change in mood states ('Profile of Mood States' (POMS) score) will be assessed by the validated Portuguese adaptation (Viana, Almeida and Santos, 2001) of a short version of the POMS. A total mood disturbance score is calculated by summing the totals for the 5 negative subscales (tension, depression, fatigue, confusion, anger) and subtracting the positive subscale (vigour), adding 100 to avoid a negative global result. Scores for each item are recorded as 0 for 'not at all' up to 4 for 'extremely'. Total mood disturbance scores can range between -64 and 100. Higher scores indicate a greater degree of mood disturbance.
Sleep parameter - Change in daytime sleepiness
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Daytime sleepiness (Epworth Sleepiness Scale (ESS) score) will be assessed by the validated Portuguese version (CEISUC, 2001) of the questionnaire. ESS global score results from the sum of 8 item scores (0-3) and can range from 0 to 24 points. The higher the ESS score, the higher that person's average sleep propensity in daily life: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; 16-24 Severe Excessive Daytime Sleepiness.
Metabolic parameter - Change in resting metabolic rate (RMR)
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
RMR (kcal) will be assessed by indirect calorimetry
Dietary intake parameter - Change in total energy intake (TEI)
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
TEI (kcal/day) will be assessed by 24h recall and quantified using a dietary analysis software
Dietary intake parameter - Change in alcohol intake
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Alcohol intake (g/day) will be assessed by 24h recall and quantified using a dietary analysis software
Dietary intake parameter - Change in the frequency of dietary intake
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Frequency of dietary intake (days/week or days/month) will be assessed using a validated food frequency questionnaire
Biochemical stress marker - Change in salivary cortisol
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Salivary cortisol (ug/dL) will be assessed by ELISA
Sleep parameter - Change in sleep latency
时间窗: Daily throughout the 4 weeks of intervention 1 and 4 weeks of intervention 2
Sleep latency (minutes) will be assessed by actigraphy
Sleep parameter - Change in total sleep time
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Total sleep time (hours) will be assessed by actigraphy
Sleep parameter - Change in sleep efficiency
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Sleep efficiency (percent) will be assessed by actigraphy
Sleep parameter - Change in biological rhythms
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Change in biological rhythms ('Morningness-Eveningness Questionnaire' (MEQ) score) will be assessed by the validated Portuguese version (Silvério, Silva and Macedo, 1998) of the MEQ. Four sections of the 16-item scale are assigned a value of 1 through 5, while the remaining twelve questions are assigned a value of 1 through 4. To obtain a global score, the sum of the components is converted to a 5-point scale: definitely morning type (\>59); moderately morning type (54-59); neither type (43-53); moderately evening type (31-42); and definitely evening type (\<31). Morningness-eveningness scores can range between 16-68.
Dietary intake parameter - Change in triptophan intake
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Triptophan intake (g/day) will be assessed by 24h recall and quantified using a dietary analysis software
Dietary intake parameter - Change in caffeine intake
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Caffeine intake (mg/day) will be assessed by 24h recall and quantified using a dietary analysis software
Dietary intake parameter - Change in total carbohydrate (CHO) intake
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
CHO intake (g/day; percent of TEI) will be assessed by 24h recall and quantified using a dietary analysis software
Dietary intake parameter - Change in the timing of dietary intake
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
Timing of dietary intake (hours) will be assessed for each food and drink mentioned in the 24h recall
Dietary intake parameter - Change in high and low glycemic index CHO
时间窗: Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)
High and low glycemic index CHO (g/day) will be assessed by 24h recall and quantified using a dietary analysis software
次要结局
- Body composition parameter - Change in fat free mass (FFM)(Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2))
- Body composition parameter - Change in fat mass (FM)(Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2))
- Body composition parameter - Change in body water(Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2))
- Body composition parameter - Change in phase angle(Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2))
- Dietary intake parameter - Change in fat intake(Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2))
- Dietary intake parameter - Change in protein intake(Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2))
- Body composition parameter - Change in visceral adipose tissue (VAT)(Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2))
- Performance parameter - Change in strength(Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2))
研究者
Filipe Teixeira
Innovation Manager
Bettery S.A.