The effect of MIND diet on sleep status, anxiety, depression, and cardiometabolic indices in obese diabetic women with insomnia: study protocol for a randomized controlled clinical trial {1}.

BACKGROUND: The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet is a plant-based and anti-inflammatory diet that has the ability to protect and manage cardiovascular and nervous system diseases. Regarding that insomnia and cardiovascular problems are x`common in type 2 diabetes mellitus (T2DM), the present study will assess the effectiveness of the MIND dietary pattern on sleep quality, cardiometabolic indicators, and other psychological indicators. METHODS: Forty-four overweight/obese T2DM women with insomnia, aged 30-65 years, will voluntarily participate in this randomized controlled trial and will be randomized to receive either a MIND low-calorie diet (MLCD) or a low-calorie diet (LCD) over a 3-month period. Before and after the study, sleep quality, some biochemical and cardiometabolic indices, cortisol, brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and oxidative stress indicators will be assessed. DISCUSSION: The use of dietary interventions in the management of T2DM complications is practical and safe. This research seeks to investigate the capacity of the MIND diet in the management of insomnia and cardiovascular problems of DM. It is expected that the results of this research will provide new perspectives on using an ideal dietary regimen to treat these health conditions. TRIAL REGISTRATION: IRCT20181111041611N8. Registered on August 7, 2023. https://www.irct.ir/trial/71772.

Microbiota Metabolite Profiles and Dietary Intake in Older Individuals with Insomnia of Short vs. Normal Sleep Duration.

Recent evidence suggests that the gut microbiota plays a role in insomnia pathogenesis. This study compared the dietary habits and microbiota metabolites of older adults with insomnia of short vs. normal sleep duration (ISSD and INSD, respectively). Data collection included sleep assessment through actigraphy, dietary analysis using the Food Frequency Questionnaire, and metabolomic profiling of stool samples. The results show that ISSD individuals had higher body mass index and a greater prevalence of hypertension. Significant dietary differences were observed, with the normal sleep group consuming more kilocalories per day and specific aromatic amino acids (AAAs) phenylalanine and tyrosine and branch-chain amino acid (BCAA) valine per protein content than the short sleep group. Moreover, metabolomic analysis identified elevated levels of the eight microbiota metabolites, benzophenone, pyrogallol, 5-aminopental, butyl acrylate, kojic acid, deoxycholic acid (DCA), trans-anethole, and 5-carboxyvanillic acid, in the short compared to the normal sleep group. The study contributes to the understanding of the potential role of dietary and microbial factors in insomnia, particularly in the context of sleep duration, and opens avenues for targeted dietary interventions and gut microbiota modulation as potential therapeutic approaches for treating insomnia.

Association of adherence to the Mediterranean diet and physical activity habits with the presence of insomnia in patients with obstructive sleep apnea.

PURPOSE: Insomnia and obstructive sleep apnea (OSA) are among the most prevalent sleep disorders and frequently co-occur, defining the sleep apnea-insomnia syndrome. However, data exploring associations between insomnia and lifestyle habits in patients with OSA are lacking. Therefore, the aim of the present study was to investigate potential associations between insomnia presence and individual lifestyle parameters in patients with mild/moderate-to-severe OSA evaluated by attended polysomnography. METHODS: These are secondary analyses, using data from a cross-sectional study among 269 Greek patients with OSA. Clinical, anthropometric, socioeconomic, and lifestyle data were collected for all participants. Insomnia presence was evaluated through the validated psychometric instrument "Athens Insomnia Scale" (AIS). Adherence to the Mediterranean diet was estimated with the MedDietScale index and physical activity habits were assessed through a validated questionnaire. Backward stepwise multiple logistic regression analysis was used to estimate the association between lifestyle habits (i.e., adherence to the Mediterranean diet and physical activity) and the likelihood of having insomnia, while adjusting for potential confounders. RESULTS: Of 269 patients newly diagnosed with OSA (aged 21-70 years; 73% men), 146 (54%) were categorized as having insomnia. In multivariable models, higher adherence to the Mediterranean diet and engagement in physical activity for ≥ 30 min/day were both associated with a lower likelihood of having insomnia (odds ratio (95% confidence intervals): 0.40 (0.18-0.91) and 0.49 (0.28-0.86), respectively). CONCLUSIONS: Results add to the limited data on the role of lifestyle in insomnia and should be further explored both in epidemiological and clinical studies.

Eucaloric Balanced Diet Improved Objective Sleep in Adolescents with Obesity.

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.

A Systematic Review, Meta-Analysis and Meta-Regression on the Effects of Carbohydrates on Sleep.

This study aimed to assess the effects of quantity, quality and periodization of carbohydrates consumption on sleep. PubMed, SCOPUS and Cochrane Library were searched through October 2020. Data were pooled using random-effects meta-analysis. Eleven articles were included in the meta-analysis which consisted of 27 separate nutrition trials, resulting in 16 comparison data sets (sleep quantity n = 11; sleep quality n = 5). Compared to high carbohydrate (HCI), low carbohydrate intake (LCI) moderately increased duration and proportion of N3 sleep stage (ES = 0.37; 95% CI = 0.18, 0.56; p < 0.001 and ES = 0.51; 95% CI = 0.33, 0.69; p < 0.001, respectively). HCI prolonged rapid eye movement (REM) stage duration (ES = -0.38; 95% CI = 0.05, -8.05; p < 0.001) and proportion (ES = -0.46; 95% CI = -0.83, -0.01; p < 0.001), compared to LCI. The quality of carbohydrate intake did not affect sleep stages. Meta-regression showed that the effectiveness of carbohydrate quantity and quality in sleep onset latency was significantly explained by alterations of carbohydrate intake as a percentage of daily energy intake (R2 = 25.87, p = 0.018) and alterations in the glycemic load (R2 = 50.8, p = 0.048), respectively. Alterations in glycemic load partially explained the variance of the effectiveness of carbohydrate quality in sleep efficiency (R2 = 89.2, p < 0.001) and wake after sleep onset (R2 = 64.9, p = 0.018). Carbohydrate quantity was shown to affect sleep architecture, and especially N3 and REM sleep stages. Alterations in both quantity and quality of carbohydrate intake showed a significant effect on sleep initiation. Variations in carbohydrate quality significantly affected measures of sleep continuation. Further studies are needed to assess the effect of long-term carbohydrate interventions on sleep.

Nutrition intervention is beneficial to the quality of life of patients with gastrointestinal cancer undergoing chemotherapy in Vietnam.

INTRODUCTION: The best treatment therapy for gastrointestinal cancer patients is assessed by the improvement of health status and quality of life (QoL) after treatments. Malnutrition is related to loss of muscle strengths which leads to lower physical performance and emotional status. Thus, this study aimed to estimate the effects of nutritional interventions on the improvement of QoL among gastrointestinal patients undergoing chemotherapy in Vietnam. METHODS: A quasi-experiment with intervention and control groups for pre- and post-intervention assessment was carried out at the Department of Oncology and Palliative Care-Hanoi Medical University Hospital from 2016 to 2019. Sixty gastrointestinal cancer patients were recruited in each group. The intervention regimen consisted of nutritional counseling, a specific menu with a recommended amount of energy, protein, and formula milk used within 2 months. Nutritional status and QoL of patients were evaluated using The Scored Patient-Generated Subjective Global Assessment (PG-SGA) and The European Organization for Research and Treatment of Cancer (EORTC). The difference in differences (DiD) method was utilized to estimate the outcome between control and intervention groups. RESULTS: After the intervention, patients of the intervention group had better changes in scores of global health status (Coef =16.68; 95% CI =7.90; 25.46), physical (Coef =14.51; 95% CI =5.34; 23.70), and role functioning (Coef =14.67; 95% CI =1.63; 27.70) compared to the control group. Regarding symptom scales, the level of fatigue, pain, and insomnia symptoms significantly reduced between pre- and post-intervention in the intervention group. In addition, living in urban areas, defined as malnourished and having low prealbumin levels, were positively associated with the lower global health status/QoL score. CONCLUSION: Nutritional therapy with high protein was beneficial to the improvement in QoL, physical function and the reduction of negative symptoms among gastrointestinal cancer patients. Early individualized nutritional support in consultation with professional dietitians during chemotherapy plays an integral part in enhancing the QoL and better treatment prognosis. CLINICAL TRIAL REGISTRATION NUMBER: NCT04517708.

[Nutrition impact on insomnia treatment]. / Impacto de la alimentación en la lucha contra el insomnio.

INTRODUCTION: Introduction: insomnia represents a growing and important health problem. If it persists, it could have a negative impact in people's welfare. Nowadays we have a wide range of techniques to measure and analyze sleep quality and quantity. Objectives: to demonstrate the impact of nutrition in sleep disorders. Methods: bibliographic review selecting the most relevant papers related to nutrition and its impact on sleep. Results: there is a direct correlation between some food or supplements and sleep quality and quantity. In addition, there exist some nutritional maneuvers that can help to prevent or solve some sleep disorders. The relationship between tryptophan and melatonin with the induction and maintenance of the sleep is clear, but vitamins, minerals, macronutrients and some dietetic habits can also have an impact. Conclusions: nutrition can have a relevant effect in the prevention and resolution of sleep disorders. Further studies are necessary to assess the real impact of nutritional treatments in insomnia.

INTRODUCCIÓN: Introducción: el insomnio representa un creciente problema de salud, con repercusiones importantes si es mantenido a largo plazo, ya que puede impactar en la salud del individuo. Actualmente se dispone de técnicas de registro del sueño y cuestionarios de análisis que facilitan la realización de estudios de calidad del sueño. Objetivos: demostrar el impacto de la nutrición en los trastornos del sueño. Métodos: revisión bibliográfica con selección de los artículos más relevantes relacionados con la nutrición y el insomnio. Resultados: existe una relación directa entre ciertos alimentos o suplementos y la calidad y cantidad del sueño, de esta manera se identifican actuaciones nutricionales que pueden ayudar a resolver o a prevenir ciertos trastornos del sueño. Parece clara la relación del triptófano y la melatonina con la inducción y el mantenimiento del sueño, pero las vitaminas, los minerales, los macronutrientes y ciertos hábitos dietéticos pueden influir también de forma directa. Conclusiones: la nutrición parece tener un papel relevante en la prevención y resolución del insomnio, si bien futuros estudios dirigidos han de aportar más evidencia al respecto.

Association of Dietary Variety and Appetite with Sleep Quality in Urban-Dwelling Older Japanese Adults.

OBJECTIVES: Although it has been shown that specific foods and nutrients are associated with sleep quality, few studies have examined the association of dietary variety and appetite with sleep quality in older adults. DESIGN AND SETTING: A cross-sectional study was conducted that examined the association of dietary variety and appetite with sleep quality in Japanese adults aged ≥70 years who resided in the metropolitan area of Tokyo, Japan. PARTICIPANTS: Data were collected in two steps: a mailed interview survey and an on-site survey. Those who responded to the surveys and met the inclusion criteria were included. MEASUREMENTS: Dietary variety, appetite, and sleep quality were assessed using a Dietary Variety Score (DVS), Council on Nutrition Appetite Questionnaire (CNAQ) score, and sleep efficiency, respectively. The sleep efficiency is the ratio of sleep duration to total time in bed (retiring time-awakening time). We defined the individuals with a sleep efficiency less than 75% as having poor sleep quality. RESULTS: Mean DVS and CNAQ score were 3.8 and 29.6 points, respectively. The rate of individuals with poor sleep quality was 11.7%. In the fully adjusted model, the odds ratios (OR) for low sleep efficiency in the middle and highest group categories of the DVS were 0.83 (95% confidence interval [CI], 0.54-1.29) and 0.50 (95% CI, 0.28-0.90), respectively, in reference to the lowest group category (p for trend = 0.023). The OR for low sleep efficiency in the middle and highest group categories of the CNAQ score were 0.73 (95% CI, 0.47-1.14) and 0.54 (95% CI, 0.30-0.96), respectively, in reference to the lowest group category (p for trend = 0.031). CONCLUSIONS: The higher DVS and CNAQ scores were significantly associated with higher sleep efficiency. Thus, dietary variety and good appetite might help maintain good sleep quality in urban-dwelling older Japanese adults.

Dynamic features of placebo effects addressing persistent insomnia disorder: A meta-analysis of placebo-controlled randomized clinical trials.

It has been accepted knowledge that placebo effects have been significant in insomnia clinical trials. However, the dynamic features of placebo effects have not been clarified. Our aim was therefore to conduct a meta-analysis of placebo-controlled randomized clinical trials to characterize the dynamic features of placebo effects addressing persistent insomnia disorder. We performed a comprehensive literature search for randomized, placebo-controlled, double-blind clinical trials evaluating the efficacy of therapeutic regimens addressing persistent insomnia disorder. We pooled separate effect size estimates (Hedge's g) of placebo and regimen conditions across trials for outcome measures, and multilevel mixed-effects models were used to explore potential sources of heterogeneity. The placebo effects were significant and robust to improve the symptoms of insomnia, and subjective measures were significantly smaller than objective measures (p < .001), but placebo response rates were nearly identical between subjective and objective measures. The overall placebo effects were influenced by publication year (p = .015), treatment duration (p = .010), sample size (p < .001) and therapeutic regimen (p < .001). Placebo effects showed a diphasic feature within treatment duration: initially a decrease and subsequently being stable; a sustained decline trend after withdrawals; and a steady-to-upward trend for a mixed therapeutic regimens in a large-scale period over decades. The dynamic features of placebo effects addressing persistent insomnia disorder may lead to the development and validation of dosing strategies that require less medication exposure to maintain clinical effects.

High glycemic index and glycemic load diets as risk factors for insomnia: analyses from the Women's Health Initiative.

BACKGROUND: Previous studies have shown mixed results on the association between carbohydrate intake and insomnia. However, any influence that refined carbohydrates have on risk of insomnia is likely commensurate with their relative contribution to the overall diet, so studies are needed that measure overall dietary glycemic index (GI), glycemic load, and intakes of specific types of carbohydrates. OBJECTIVE: We hypothesized that higher GI and glycemic load would be associated with greater odds of insomnia prevalence and incidence. METHODS: This was a prospective cohort study with postmenopausal women who participated in the Women's Health Initiative Observational Study, investigating the relations of GI, glycemic load, other carbohydrate measures (added sugars, starch, total carbohydrate), dietary fiber, and specific carbohydrate-containing foods (whole grains, nonwhole/refined grains, nonjuice fruits, vegetables, dairy products) with odds of insomnia at baseline (between 1994 and 1998; n = 77,860) and after 3 y of follow-up (between 1997 and 2001; n = 53,069). RESULTS: In cross-sectional and longitudinal analyses, higher dietary GI was associated with increasing odds of prevalent (fifth compared with first quintile OR: 1.11; CI: 1.05, 1.16; P-trend = 0.0014) and incident (fifth compared with first quintile OR: 1.16; CI: 1.08, 1.25; P-trend < 0.0001) insomnia in fully adjusted models. Higher intakes of dietary added sugars, starch, and nonwhole/refined grains were each associated with higher odds of incident insomnia. By contrast, higher nonjuice fruit and vegetable intakes were significantly associated with lower odds of incident insomnia. Also, higher intakes of dietary fiber, whole grains, nonjuice fruit, and vegetables were significantly associated with lower odds of prevalent insomnia. CONCLUSIONS: The results suggest that high-GI diets could be a risk factor for insomnia in postmenopausal women. Substitution of high-GI foods with minimally processed, whole, fiber-rich carbohydrates should be evaluated as potential treatments of, and primary preventive measures for, insomnia in postmenopausal women.

Magnesium Intake and Sleep Disorder Symptoms: Findings from the Jiangsu Nutrition Study of Chinese Adults at Five-Year Follow-Up.

(1) Background: In clinical trials, dietary magnesium use can improve insomnia symptoms. However, little is known about the association between dietary magnesium consumption and sleep disorder symptoms including daytime falling asleep, sleepiness and snoring at the population level. (2) Methods: We used data from 1487 adults aged 20 and above attending the Jiangsu Nutrition Study. At baseline in 2002, dietary magnesium was assessed by 3-day weighed food records. At follow-up in 2007, sleep disorder symptoms, including daytime falling asleep, sleepiness and snoring at night, were gathered using a sleep questionnaire. (3) Results: The mean intake of magnesium was 332.5 mg/day. In total, 5.3%, 13.2% and 35.7% of the subjects reported daytime falling asleep, daytime sleepiness, and snoring during sleep, respectively. Compared with the lowest quartile of magnesium intake, the highest quartile was associated with decreased likelihood of falling asleep (odds ratio (OR) 0.12 (0.02, 0.57)) in women but not in men after adjusting for demographic, anthropometric, lifestyle factors, hypertension, and overall dietary patterns. No associations were found between dietary magnesium intake and daytime sleepiness nor night snoring in either gender. (4) Conclusions: Dietary magnesium intake may have long-term benefits in reducing the likelihood of daytime falling asleep in women.

Mediterranean diet pattern and sleep duration and insomnia symptoms in the Multi-Ethnic Study of Atherosclerosis.

Sleep duration and sleep quality are important predictors of risk for cardiovascular disease (CVD). One potential link between sleep health and CVD is through lifestyle factors such as diet. To clarify the association between diet and sleep, we assessed the associations of sleep duration and insomnia symptoms with current Mediterranean-style diet (aMed) and with historical changes in aMed score. Actigraphy-measured sleep duration and self-reported insomnia symptoms categorized as insomnia with short sleep (<6 hr/night), insomnia without short sleep, no insomnia with short sleep, and no insomnia or short sleep were obtained from 2068 individuals who also had dietary intake data. A 10-point aMed score, derived from a self-report food frequency questionnaire, was collected concurrently with the sleep assessment and 10 years before. Compared with individuals who currently reported a low aMed score, those with a moderate-high aMed score were more likely to sleep 6-7 vs. <6 hr/night (p < 0.01) and less likely to report insomnia symptoms occurring with short sleep (vs. no insomnia or short sleep alone; p < 0.05). An increase in aMed score over the preceding 10 years was not associated with sleep duration or insomnia symptoms. However, compared with those with decreasing aMed score, individuals with an unchanging score reported fewer insomnia symptoms (p ≤ 0.01). These results suggest that a Mediterranean-style diet is associated with adequate sleep duration, less insomnia symptoms, and less likely to have insomnia accompanied by short sleep. Further research should identify possible mediators through which diet may promote adequate sleep duration and reduce the risk of insomnia.

Pilot Study of the Tart Cherry Juice for the Treatment of Insomnia and Investigation of Mechanisms.

BACKGROUND: Insomnia is common in the elderly and is associated with chronic disease, but use of hypnotics increases the incidence of falls. Montmorency tart cherry juice has improved insomnia by self-report questionnaire. STUDY QUESTION: Is insomnia confirmed by polysomnography and is tryptophan availability a potential mechanism for treating insomnia? STUDY DESIGN: A placebo-controlled balanced crossover study with subjects older than 50 years and insomnia were randomized to placebo (2 weeks) or cherry juice (2 weeks) (240 mL 2 times/d) separated by a 2-week washout. MEASURES AND OUTCOMES: Sleep was evaluated by polysomnography and 5 validated questionnaires. Serum indoleamine 2,3-dioxygenase (IDO), the kynurenine-to-tryptophan ratio, and prostaglandin E2 were measured. In vitro, Caco-2 cells were stimulated with interferon-gamma, and the ability of cherry juice procyanidin to inhibit IDO which degrades tryptophan and stimulates inflammation was measured. The content of procyanidin B-2 and other major anthocyanins in cherry juice were determined. RESULTS: Eleven subjects were randomized; 3 with sleep apnea were excluded and referred. The 8 completers with insomnia increased sleep time by 84 minutes on polysomnography (P = 0.0182) and sleep efficiency increased on the Pittsburgh Sleep Quality Index (P = 0.03). Other questionnaires showed no significant differences. The serum kynurenine-to-tryptophan ratio decreased, as did the level of prostaglandin E2 (both P < 0.05). In vitro, cherry juice procyanidin B-2 dose-dependently inhibited IDO. CONCLUSIONS: Cherry juice increased sleep time and sleep efficiency. Cherry juice procyanidin B-2 inhibited IDO, increased tryptophan availability, reduced inflammation, and may be partially responsible for improvement in insomnia.

Effects of a phyto complex on well-being of climacteric women.

AIM: The aim of this study was to assess the effects of a phyto complex on menopausal symptoms. MATERIAL AND METHODS: A total of 151 women aged 42-67 years were enrolled. They were in spontaneous or surgical menopause by at least 12 months, reporting symptoms referable to the climacteric syndrome. Two validated and standardized tests were given to the whole sample at the entrance of the study (T0) and after 6 months of treatment (T6): the Greene Climacteric Scale (GCS) and the Beck Depression Inventory (BDI). Interim evaluations were carried out at 1-3 months (T1 and T3) on five symptoms selected from the GCS. The phyto complex was given to each enrolled woman, from the T0 to T6 time-points, for a total of 180 days. RESULTS: At the T0 time-point, the average scores were: GCS, 28.98 (standard deviation [SD] ± 10.71); BDI, 14.48 (SD ± 6.5). At the T1 time-point, five parameters of the GCS were assessed with a reduction of 36.25% in symptoms (5.69, SD ± 3.53). At the T6 time-point the assessment was completed: average GCS results were 11.54 (SD ± 8.01) with a 60.17% improvement; and average BDI results were 6.11 (SD ± 4.6) with a 58.91% improvement in the depressive symptoms. CONCLUSIONS: The phyto complex under consideration is an effective tool to counter, in a quick and long-lasting manner, the most common and nagging symptoms of the climacteric syndrome, such as hot flushes, insomnia and depression.

Effect of kiwifruit consumption on sleep quality in adults with sleep problems.

Numerous studies have revealed that kiwifruit contains many medicinally useful compounds, among which antioxidants and serotonin may be beneficial in the treatment of the sleep disorders. The aim of this study was to evaluate the effects of kiwifruit on sleep patterns, including sleep onset, duration, and quality. In this study, we applied a free-living, self-controlled diet design. Twenty-four subjects (2 males, 22 females) 20 to 55 years of age consumed 2 kiwifruits 1 hour before bedtime nightly for 4 weeks. The Chinese version of the Pittsburgh Sleep Quality Index (CPSQI), a 3-day sleep diary, and the Actigraph sleep/activity logger watch were used to assess the subjective and objective parameters of sleep quality, including time to bed, time of sleep onset, waking time after sleep onset, time of getting up, total sleep time, and self-reported sleep quality and sleep onset latency, waking time after sleep onset, total sleep time, and sleep efficiency before and after the intervention. After 4 weeks of kiwifruit consumption, the subjective CPSQI score, waking time after sleep onset, and sleep onset latency were significantly decreased (42.4%, 28.9%, and 35.4%, respectively). Total sleep time and sleep efficiency were significantly increased (13.4% and 5.41%, respectively). Kiwifruit consumption may improve sleep onset, duration, and efficiency in adults with self-reported sleep disturbances. Further investigation of the sleep-promoting properties of kiwifruit may be warranted.

Effects of a tart cherry juice beverage on the sleep of older adults with insomnia: a pilot study.

This study ascertained whether a proprietary tart cherry juice blend (CherryPharm, Inc., Geneva, NY, USA) associated with anecdotal reports of sleep enhancement improves subjective reports of insomnia compared to a placebo beverage. The pilot study used a randomized, double-blind, crossover design where each participant received both treatment and placebo for 2 weeks with an intervening 2-week washout period. Sleep continuity (sleep onset, wake after sleep onset, total sleep time, and sleep efficiency) was assessed by 2-week mean values from daily sleep diaries and disease severity by the Insomnia Severity Index in a cohort of 15 older adults with chronic insomnia who were otherwise healthy. The tart cherry juice beverage was associated with statistically significant pre- to post-treatment improvements on all sleep variables. When compared to placebo, the study beverage produced significant reductions in insomnia severity (minutes awake after sleep onset); no such improvements were observed for sleep latency, total sleep time, or sleep efficiency compared to placebo. Effect sizes were moderate and in some cases negligible. The results of this pilot study suggest that CherryPharm, a tart cherry juice blend, has modest beneficial effects on sleep in older adults with insomnia with effect sizes equal to or exceeding those observed in studies of valerian and in some, but not all, studies of melatonin, the two most studied natural products for insomnia. These effects, however, were considerably less than those for evidence-based treatments of insomnia: hypnotic agents and cognitive-behavioral therapies for insomnia.

The effect of Lactobacillus helveticus fermented milk on sleep and health perception in elderly subjects.

OBJECTIVE: To study the effect of Lactobacillus helveticus fermented milk on sleep and health perception in elderly healthy subjects. SUBJECTS: The study included 29 healthy elderly subjects aged 60-81 years. METHODS: Prospective, randomized, double-blind and placebo-controlled, with a crossover design. The study included two intervention periods of 3 weeks each, separated by a 3-week washout period. Subjects took 100 g of fermented milk drink or a placebo drink (artificially acidified milk) daily in the first supplementary period and the other drink in the second supplementary period. For each period, we measured sleep quality by means of actigraphy and a sleep questionnaire, and assessed the quality of life (QOL) by SF-36 health survey. RESULTS: There was a significant improvement in sleep efficiency (P=0.03) and number of wakening episodes (P=0.007) in actigraph data after intake of fermented milk, whereas no significant changes were observed for the placebo. Fermented milk did not improve the SF-36 scores significantly from the baseline period. In the GH domain (general health perception) of the SF-36, however, there was marginal improvement as compared to the baseline period. Although the difference between fermented milk and placebo was not statistically significant for any of the sleep or QOL parameters, fermented milk produced slightly greater mean values for many parameters. CONCLUSION: This short-term (3-week) intervention study indicates that Lactobacillus helveticus fermented milk may have a more favorable effect on improving sleep in healthy elderly people as compared with placebo.

Milk intolerance in children with persistent sleeplessness: a prospective double-blind crossover evaluation.

From July 1986 to July 1988, 146 children less than 5 years of age were referred by their physicians to our university sleep clinic for continual waking and crying during sleep hours. For 85 children (58.2%), the sleeplessness was attributed to inappropriate sleep habits. For 17 children (11.6%), no explanation was found for the sleep difficulties in spite of an extensive workup. Their median age at referral was 13.5 months (range 2.5 to 29 months). Their persistent sleeplessness was tentatively attributed to an undiagnosed intolerance to cow's milk. Cow's milk was excluded from their diet. In 15 children sleep normalized after 5 weeks (range 4 to 6 weeks). As seen from the parents' logs, the median time needed by the children to fall asleep decreased from 15 minutes (range 15 to 60 minutes) to 10 minutes (range 10 to 15 minutes, P = .001). The number of complete arousals decreased from 5 (range 1 to 12) to less than 1 per night (range 0 to 2) (P = .001). Total sleep time per 24 hours increased from 5.5 hours (range 3 to 8.5 hours) to 13.0 hours (range 10 to 14.5 hours, P = .001). Sleep normalized in one child who continued to receive no cow's milk only after the hydrolyzed hypoallergenic diet was discontinued. In every child, a double-blind crossover challenge was conducted involving a control diet containing no cow's milk and a diet containing cow's milk. The challenge induced the reappearance of insomnia and agitated behavior in all except one child. The child's initial sleep difficulties were retrospectively attributed to inappropriate sleep habits.(ABSTRACT TRUNCATED AT 250 WORDS)