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The effect of vitamin B12-supplementation on actigraphy measured sleep pattern; a randomized control trial.
Hysing, M, Strand, TA, Chandyo, RK, Ulak, M, Ranjitkar, S, Schwinger, C, Shrestha, M, Kvestad, I
Clinical nutrition (Edinburgh, Scotland). 2022;(2):307-312
Abstract
BACKGROUND Vitamin B12 deficiency is common worldwide and has been associated with poor sleep. The effect of vitamin B12 supplementation on sleep in infants is not known. AIMS To measure the effect of daily supplementation of vitamin B12 for one year on sleep in infants at risk of deficiency. METHODS This was an individually randomized double-blind placebo-controlled trial in 600 infants in low-to middle-income neighborhoods in Bhaktapur, Nepal of daily supplementation of vitamin B12 for one year. Infants were included if they were 6-11 month year-old and with a length-for-age less than one z-score. Sleep was a predefined, secondary outcome, and was measured by actigraphy including sleep duration at night and total sleep duration (day and night), sleep onset latency (SOL), and wake after sleep onset (WASO). The effect of vitamin B12 on sleep was additionally assessed in predefined subgroups defined by stunting, underweight, vitamin B12 status, low birthweight, anemia and exclusive breastfeeding for 3 months. RESULTS There was no effect of vitamin B12 supplementation on sleep duration at night, total sleep duration, or WASO. There was a small significant negative effect for SOL. None of the included subgroup analyses revealed effect modification on any of the sleep outcomes. CONCLUSION Overall, vitamin B12 supplementation did not have an effect on sleep in infants or for high-risk subgroups, with the exception of a small negative effect for SOL. The present study does not support vitamin B12 supplementation to improve sleep in infants. TRIAL REGISTRATION clinicaltrials.gov: NCT02272842. UNIVERSAL TRIAL NUMBER U1111-1161-5187.
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The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, double-blind trial.
Jakobsen, G, Engstrøm, M, Hjermstad, MJ, Rosland, JH, Aass, N, Albert, E, Kaasa, S, Fayers, P, Klepstad, P, Paulsen, Ø
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2021;(4):2047-2055
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Abstract
PURPOSE Although corticosteroids are frequently used in patients with advanced cancer, few studies have examined the impact of these drugs on patient-reported sleep. We aimed to examine the short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer. METHODS Patient-reported sleep was a predefined secondary outcome in a prospective, randomized, placebo-controlled, double-blind trial that evaluated the analgesic efficacy of corticosteroids in advanced cancer patients (18+), using opioids, and having pain ≥ 4 past 24 h (NRS 0-10). Patients were randomized to the methylprednisolone group with methylprednisolone 16 mg × 2/day or placebo for 7 days. The EORTC QLQ-C30 (0-100) and the Pittsburgh Sleep Quality Index questionnaire (PSQI) (0-21) were used to assess the impact of corticosteroids on sleep at baseline and at day 7. RESULTS Fifty patients were randomized of which 25 were analyzed in the intervention group and 22 in the control group. Mean age was 64 years, mean Karnofsky performance status was 67 (SD 13.3), 51% were female, and the mean oral daily morphine equivalent dose was 223 mg (SD 222.77). Mean QLQ-C30 sleep score at baseline was 29.0 (SD 36.7) in the methylprednisolone group and 24.2 (SD 27.6) in the placebo group. At day 7, there was no difference between the groups on QLQ-C30 sleep score (methylprednisolone 20.3 (SD 32.9); placebo 28.8 (SD 33.0), p = 0.173). PSQI showed similar results. CONCLUSIONS Methylprednisolone 16 mg twice daily for 7 days had no impact on patient-reported sleep in this cohort of patients with advanced cancer. TRIAL REGISTRATION Clinical trial information NCT00676936 (13.05.2008).
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Probiotic supplementation elicits favourable changes in muscle soreness and sleep quality in rugby players.
Harnett, JE, Pyne, DB, McKune, AJ, Penm, J, Pumpa, KL
Journal of science and medicine in sport. 2021;(2):195-199
Abstract
UNLABELLED Probiotic supplementation may offer team sport athletes a range of benefits beyond the immune and gastrointestinal systems. OBJECTIVES To examine the effects of a probiotic formulation on perceptual markers of sleep quality and quantity, and muscle soreness, leg heaviness and motivation in elite rugby union athletes. METHODS A double-blind randomised controlled trial involving 19 elite male rugby athletes was conducted over 17 weeks encompassing both domestic and international competition. Psychometric variables and salivary biomarkers were assessed twice a week. Athletes were assigned either a daily probiotic (Ultrabiotic 60™) and Saccharomyces boulardii (during international competition) or a placebo. Associations between psychometric scores for perceptual and salivary biomarkers of sleep (melatonin) and inflammation C-reactive protein (CRP) were investigated. RESULTS Muscle soreness was ∼0.5 units lower (F(1, 343)=42.646, p<0.0001) and leg heaviness scores ∼0.7 units lower (F(1, 334)=28.990, p<0.0001) in the probiotic group compared to the placebo group. Across both groups, as self-reported muscle soreness scores and salivary CRP concentrations increased, sleep quantity, quality and motivation scores decreased. Conversely as muscle soreness scores and CRP decreased, sleep quantity and quality, and motivation scores improved. CONCLUSIONS A long-term programme of probiotic supplementation in international-level rugby union players may yield favourable effects on self-reported muscle soreness and sleep quality associated with muscle soreness during training and competitions.
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The Effect of A Whey-Protein and Galacto-Oligosaccharides Based Product on Parameters of Sleep Quality, Stress, and Gut Microbiota in Apparently Healthy Adults with Moderate Sleep Disturbances: A Randomized Controlled Cross-Over Study.
Schaafsma, A, Mallee, L, van den Belt, M, Floris, E, Kortman, G, Veldman, J, van den Ende, D, Kardinaal, A
Nutrients. 2021;(7)
Abstract
People experiencing sleep problems may benefit from nutrients supporting serotonin metabolism and stress reduction. We studied the effect of a dairy-based product (DP) containing protein, galacto-oligosaccharides, vitamins and minerals, on sleep quality, stress, and gut-microbiota. In a cross-over RCT (three weeks intervention; three weeks washout), adults (n = 70; 30-50 y) with sleep disturbances (Pittsburgh Sleep Quality Index (PSQI) ≥ 9) consumed products 1 h before bed-time. Sleep quality (PSQI) was measured weekly, stress at base- and end-line (Depression Anxiety Stress Scale and saliva cortisol). Fecal samples were collected in the 1st intervention period only. Compared to placebo (skimmed milk), PSQI was only lower at day 14 in the 2nd intervention period in intention-to-treat (ITT) (p = 0.017; n = 69) and per-protocol (PP) (p = 0.038; n = 64) analyses. Post-hoc analysis (modified-PP: n=47, with baseline PSQI ≥ 9, and endline day 14), however, showed a decrease in PSQI (-1.60 ± 2.53; p = 0.034). Early morning saliva cortisol decreased versus placebo (p = 0.045). Relative abundance of Bifidobacterium increased (p = 0.02). Redundancy analysis showed an inverse relationship between baseline microbiota composition and baseline PSQI (p = 0.046). Thus, although DP did not improve sleep quality in ITT and PP populations, it did in the modPP. DP reduced salivary cortisol and stimulated Bifidobacterium, which possibly is important for sleep improvement.
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ɑ-Lactalbumin Improves Sleep and Recovery after Simulated Evening Competition in Female Athletes.
Miles, KH, Clark, B, Fowler, PM, Gratwicke, MJ, Martin, K, Welvaert, M, Miller, J, Pumpa, KL
Medicine and science in sports and exercise. 2021;(12):2618-2627
Abstract
PURPOSE This study aimed to determine the efficacy of α-lactalbumin (A-LAC) supplementation for improving sleep and performance recovery after simulated evening competition in female athletes. METHODS Sixteen trained women (mean ± SD: age, 27 ± 7 yr; mass, 62 ± 10 kg; stature, 167 ± 8 cm) participated in this randomized double-blind three-arm crossover study. Participants completed a simulated evening competition before consuming either an A-LAC whey protein, whey protein placebo (PLA), or water control (CON) beverage. Sleep was monitored via polysomnography, and participants completed a series of physical, cognitive, and perceptual assessments before, and 14 and 24 h after simulated competition. RESULTS Non-rapid eye movement stage 2 sleep increased after competition in A-LAC (pre, 199 ± 44 min; post, 212 ± 37 min) but decreased in CON (pre, 228 ± 43 min; post, 195 ± 40 min) and PLA (pre, 224 ± 25 min; post, 211 ± 35 min; P = 0.012). In addition, Yo-Yo Intermittent Recovery Test Level 1 distance improved over time in A-LAC (baseline, 664 ± 332 m; 14 h post, 667 ± 326 m; 24 h post, 781 ± 427 m) compared with CON (baseline, 741 ± 366 m; 14 h post, 648 ± 351 m; 24 h post, 720 ± 407 m) and PLA (baseline, 763 ± 394 m; 14 h post, 636 ± 366 m; 24 h post, 720 ± 396 m; P < 0.001). CONCLUSIONS The findings indicate that A-LAC supplementation may be useful for retaining some sleep characteristics after evening competition, leading to improved physical performance in female athletes.
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The AWAKE-HF Study: Sacubitril/Valsartan Impact on Daily Physical Activity and Sleep in Heart Failure.
Khandwalla, RM, Grant, D, Birkeland, K, Heywood, JT, Fombu, E, Owens, RL, Steinhubl, SR, ,
American journal of cardiovascular drugs : drugs, devices, and other interventions. 2021;(2):241-254
Abstract
BACKGROUND AWAKE-HF evaluated the effect of the initiation of sacubitril/valsartan versus enalapril on activity and sleep using actigraphy in patients who have heart failure with reduced ejection fraction (HFrEF). METHODS In this randomized, double-blind study, patients with HFrEF (n = 140) were randomly assigned to sacubitril/valsartan or enalapril for 8 weeks, followed by an 8-week open-label phase with sacubitril/valsartan. Primary endpoint was change from baseline in mean activity counts during the most active 30 min/day at week 8. The key secondary endpoint was change in mean nightly activity counts/minute from baseline to week 8. Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) was an exploratory endpoint. RESULTS There were no detectable differences between groups in geometric mean ratio of activity counts during the most active 30 min/day at week 8 compared with baseline (0.9456 [sacubitril/valsartan:enalapril]; 95% confidence interval [CI] 0.8863-1.0088; P = 0.0895) or in mean change from baseline in activity during sleep (difference: 2.038 counts/min; 95% CI - 0.062 to 4.138; P = 0.0570). Change from baseline to week 8 in KCCQ-23 was 2.89 for sacubitril/valsartan and 4.19 for enalapril, both nonsignificant. CONCLUSIONS In AWAKE-HF, no detectable differences in activity and sleep were observed when comparing sacubitril/valsartan with enalapril in patients with HFrEF using a wearable biosensor. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02970669.
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Efficacy of a Multi-Component m-Health Diet, Physical Activity, and Sleep Intervention on Dietary Intake in Adults with Overweight and Obesity: A Randomised Controlled Trial.
Fenton, S, Burrows, TL, Collins, CE, Rayward, AT, Murawski, B, Duncan, MJ
Nutrients. 2021;(7)
Abstract
This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI -1922, -101), less sodium (-313.2 mg/day; 95% CI -591.3, -35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (-3.6%EI; 95% CI -6.5, -0.7), baked sweet products (-2.0%EI; 95% CI -3.6, -0.4), and packaged snacks (-1.1%EI; 95% CI -2.2, -0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.
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The impact of daily caffeine intake on nighttime sleep in young adult men.
Weibel, J, Lin, YS, Landolt, HP, Kistler, J, Rehm, S, Rentsch, KM, Slawik, H, Borgwardt, S, Cajochen, C, Reichert, CF
Scientific reports. 2021;(1):4668
Abstract
Acute caffeine intake can delay sleep initiation and reduce sleep intensity, particularly when consumed in the evening. However, it is not clear whether these sleep disturbances disappear when caffeine is continuously consumed during daytime, which is common for most coffee drinkers. To address this question, we investigated the sleep of twenty male young habitual caffeine consumers during a double-blind, randomized, crossover study including three 10-day conditions: caffeine (3 × 150 mg caffeine daily), withdrawal (3 × 150 mg caffeine for 8 days, then switch to placebo), and placebo (3 × placebo daily). After 9 days of continuous treatment, electroencephalographically (EEG)-derived sleep structure and intensity were recorded during a scheduled 8-h nighttime sleep episode starting 8 (caffeine condition) and 15 h (withdrawal condition) after the last caffeine intake. Upon scheduled wake-up time, subjective sleep quality and caffeine withdrawal symptoms were assessed. Unexpectedly, neither polysomnography-derived total sleep time, sleep latency, sleep architecture nor subjective sleep quality differed among placebo, caffeine, and withdrawal conditions. Nevertheless, EEG power density in the sigma frequencies (12-16 Hz) during non-rapid eye movement sleep was reduced in both caffeine and withdrawal conditions when compared to placebo. These results indicate that daily caffeine intake in the morning and afternoon hours does not strongly impair nighttime sleep structure nor subjective sleep quality in healthy good sleepers who regularly consume caffeine. The reduced EEG power density in the sigma range might represent early signs of overnight withdrawal from the continuous presence of the stimulant during the day.
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The Impact of Pulmonary Rehabilitation on 24-Hour Movement Behavior in People With Chronic Obstructive Pulmonary Disease: New Insights From a Compositional Perspective.
Burge, AT, Palarea-Albaladejo, J, Holland, AE, Abramson, MJ, McDonald, CF, Mahal, A, Hill, CJ, Lee, AL, Cox, NS, Lahham, A, et al
Journal of physical activity & health. 2021;(1):13-20
Abstract
BACKGROUND Physical activity levels are low in people with chronic obstructive pulmonary disease, and there is limited knowledge about how pulmonary rehabilitation transforms movement behaviors. This study analyzed data from a pulmonary rehabilitation trial and identified determinants of movement behaviors. METHODS Objectively assessed time in daily movement behaviors (sleep, sedentary, light-intensity physical activity, and moderate- to vigorous-intensity physical activity) from a randomized controlled trial (n = 73 participants) comparing home- and center-based pulmonary rehabilitation was analyzed using conventional and compositional analytical approaches. Regression analysis was used to assess relationships between movement behaviors, participant features, and response to the interventions. RESULTS Compositional analysis revealed no significant differences in movement profiles between the home- and center-based groups. At end rehabilitation, conventional analyses identified positive relationships between exercise capacity (6-min walk distance), light-intensity physical activity, and moderate- to vigorous-intensity physical activity time. Compositional analyses identified positive relationships between a 6-minute walk distance and moderate- to vigorous-intensity physical activity time, accompanied by negative relationships with sleep and sedentary time (relative to other time components) and novel relationships between body mass index and light-intensity physical activity/sedentary time. CONCLUSION Compositional analyses following pulmonary rehabilitation identified unique associations between movement behaviors that were not evident in conventional analyses.
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Eucaloric Balanced Diet Improved Objective Sleep in Adolescents with Obesity.
Saidi, O, Rochette, E, Del Sordo, G, Doré, É, Merlin, É, Walrand, S, Duché, P
Nutrients. 2021;(10)
Abstract
BACKGROUND A better understanding of the influence of energy balance on sleep in adolescents, particularly those with obesity, could help develop strategies to optimize sleep in these populations. The purpose of this study was to investigate sleep under ad libitum-vs-controlled diets adjusted to energy requirement (eucaloric) among adolescents with obesity and their normal weight controls. METHODS Twenty-eight male adolescents aged between 12 and 15 years, n = 14 adolescents with obesity (OB: BMI ≥ 90th centile) and n = 14 normal weight age matched controls (NW), completed an experimental protocol comprising ad libitum or eucaloric meals for three days, in random order. During the third night of each condition, they underwent in home polysomnography (PSG). RESULTS An interaction effect of energy intake (EI) was detected (p < 0.001). EI was higher during ad libitum compared to the eucaloric condition (p < 0.001) and in OB compared to NW (p < 0.001) in the absence of any substantial modification to macronutrient proportions. Analyses of energy intake distribution throughout the day showed a significant interaction with both a condition and group effect during lunch and dinner. Sleep improvements were noted in OB group during the eucaloric condition compared to ad libitum with reduced sleep onset latency and N1 stage. Sleep improvements were correlated to reduced EI, especially during the evening meal. CONCLUSION Simply adjusting dietary intake to energy requirement and reducing the energy proportion of the evening meal could have therapeutic effects on sleep in adolescents with obesity. However, positive energy balance alone cannot justify worsened sleep among adolescents with obesity compared to normal weight counterparts.