scholarly journals Neural correlates of sleep recovery following melatonin treatment for pediatric concussion: a randomized control trial

2020 ◽  
Author(s):  
Kartik K Iyer ◽  
Andrew Zalesky ◽  
Luca Cocchi ◽  
Karen M Barlow
Keyword(s):  
Sleep Disturbances ◽  
Functional Neuroimaging ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Neural Correlates ◽  
Self Report ◽  
Symptom Improvement ◽  
Melatonin Treatment ◽  
Link Type ◽  
Over Time

Evidence-based treatments for children with persistent post-concussion symptoms (PPCS) are few and limited. Common PPCS complaints such as sleep disturbance and fatigue could be ameliorated via the supplementation of melatonin, which has significant neuroprotective and anti-inflammatory properties. This study aims to identify neural correlates of melatonin treatment with changes in sleep disturbances and clinical recovery in a pediatric cohort with PPCS. We examined structural and functional neuroimaging (MRI) in 62 children with PPCS in a randomized, double-blind, placebo-controlled trial of 3mg or 10mg of melatonin (NCT01874847). The primary outcome was the total youth self-report Post-Concussion Symptom Inventory (PCSI) score after 28 days of treatment. Secondary outcomes included the change in the sleep domain PCSI score and sleep-wake behavior (assessed using wrist-worn actigraphy). Whole-brain analyses of (i) functional connectivity (FC) of resting-state fMRI, and (ii) structural grey matter (GM) volumes via voxel-based morphometry were assessed immediately before and after melatonin treatment and compared to placebo in order to identify neural effects of melatonin treatment. Increased FC of posterior default mode network (DMN) regions with visual, somatosensory and dorsal networks was detected in the melatonin groups over time. FC increases also corresponded with reduced wake periods (r=-0.27, p=0.01). Children who did not recover (n=39) demonstrated significant FC increases within anterior DMN and limbic regions compared to those that did recover (i.e. PCSI scores returned to pre-injury level n=23) over time, (p=0.026). Increases in GM volume within the posterior cingulate cortex were found to correlate with reduced wakefulness after sleep onset (r=-0.32, p=0.001) and sleep symptom improvement (r=0.29, p=0.02). Although the melatonin treatment trial was negative and did not result in PPCS recovery (with or without sleep problems), the relationship between melatonin and improvement in sleep parameters were linked to changes in function-structure within and between brain regions interacting with the DMN. Clinical Trial Registration ID#NCT01874847.

scholarly journals The effects of a novel bicarbonate loading protocol on serum bicarbonate concentration: a randomized controlled trial

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Adam Marcus ◽  
Amerigo Rossi ◽  
Andrew Cornwell ◽  
Steven A. Hawkins ◽  
Nazareth Khodiguian
Keyword(s):  
Sodium Bicarbonate ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Elevated Serum ◽  
Self Report ◽  
Serum Bicarbonate ◽  
Bicarbonate Concentration ◽  
Link Type ◽  
Men 2 ◽  
Gastrointestinal Distress

Abstract Background Previous studies have shown that sodium bicarbonate ingestion may enhance intense exercise performance, but may also cause severe gastrointestinal distress. The purpose of this study was to determine whether a modified sodium bicarbonate (SB) ingestion protocol would elevate serum bicarbonate concentration more than previous methods without causing gastrointestinal distress. Methods In randomized order, seven (5 men, 2 women) elite middle-distance runners ingested either placebo, Modified SB (600 mg·kg− 1 over 19.5 h), or Acute SB (300 mg·kg− 1) in opaque gelatin capsules. Baseline and post-ingestion blood samples were analyzed for bicarbonate, pH, sodium, hematocrit, and lactate. Repeated measures ANOVA (2 time points × 3 conditions) were analyzed to determine differences in serum bicarbonate, lactate, sodium, blood pH, and hematocrit. Gastrointestinal distress was assessed via self-report on a Likert scale of 1–10. Simple (condition) and repeated (time) within-participant contrasts were used to determine the location of any statistically significant main and interaction effects (p ≤ 0.05). Results Both Modified SB (7.6 mmol·L− 1, p < 0.01) and Acute SB (5.8 mmol·L− 1, p < 0.01) increased serum bicarbonate concentration compared to the placebo (p ≤ 0.05). Post-ingestion serum bicarbonate concentration was significantly higher for the Modified SB (34.7 ± 2.2 mmol·L− 1, 28.0% increase) trials than the Acute SB (33.5 ± 2.0 mmol·L− 1, 20.9% increase) trials (p = 0.05). There was no reported severe GI distress in the Modified SB trials, but two cases in the Acute SB trials. Conclusions Modified SB elevated serum bicarbonate concentration more than Acute SB, without any severe gastrointestinal side effects. Consequently, it is recommended that future experimentation involving SB by researchers and athletes use the novel ingestion protocol described in this study due to its potential for improved effectiveness and reduced gastrointestinal impact. Trial registration ClinicalTrials.gov ,NCT03813329. Registered 23 January 2019 - Retrospectively registered,

scholarly journals Educational films for improving screening and self-management of gestational diabetes in India and Uganda (GUIDES): study protocol for a cluster-randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Laura L. Oakley ◽  
Deepa R ◽  
Arthur Namara ◽  
Biswamitra Sahu ◽  
Iliatha Papachristou Nadal ◽  
...  
Keyword(s):  
Gestational Diabetes ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Self Report ◽  
Self Management ◽  
Secondary Outcome ◽  
Behavioural Intervention ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack of knowledge and skills about GDM on the part of both providers and patients. Following contextual analysis, we developed an educational/behavioural intervention for GDM delivered through a package of culturally tailored films. This trial aims to evaluate whether the intervention can improve the timely detection and management of GDM in two LMIC settings. Methods Two independent cluster randomised controlled trials, one each to be conducted in Uganda and India. Thirty maternity facilities in each country have been recruited to the study and randomised in a 1:1 ratio to the intervention and control arms. The intervention comprises of three interconnected sets of films with the following aims: to improve knowledge of GDM guidelines and skills of health providers, to raise awareness of GDM screening among pregnant women and their families, and to improve confidence and skills in self-management among those diagnosed with GDM. In facilities randomised to the intervention arm, a GDM awareness-raising film will be shown in antenatal care waiting rooms, and four films for pregnant women with GDM will be shown in group settings and made available for viewing on mobile devices. Short films for doctors and nurses will be presented at professional development meetings. Data will be collected on approximately 10,000 pregnant women receiving care at participating facilities, with follow-up at 32 weeks gestational age and 6 weeks postnatally. Women who self-report a GDM diagnosis will be invited for a clinic visit at 34 weeks. Primary outcomes are (a) the proportion of women who report a GDM diagnosis by 32 weeks of pregnancy and (b) glycaemic control (fasting glucose and HbA1C) in women with GDM at ~34 weeks of pregnancy. The secondary outcome is a composite measure of GDM-related adverse perinatal-neonatal outcome. Discussion Screening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings. Trial registration ClinicalTrials.gov NCT03937050, registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605, registered on 26 February 2020.

Clinical Benefits of Ruxolitinib Therapy in Myelofibrosis Patients with Varying Degrees of Splenomegaly and Symptoms

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1727-1727 ◽  
Author(s):  
Ruben A. Mesa ◽  
Jason Gotlib ◽  
Hagop M. Kantarjian ◽  
William Sun ◽  
Srdan Verstovsek
Keyword(s):  
Symptom Severity ◽  
Research Funding ◽  
Mixed Model ◽  
Controlled Trial ◽  
Clinical Status ◽  
Phase Iii ◽  
International Prognostic Scoring System ◽  
Symptom Improvement ◽  
Symptom Scores ◽  
Over Time

Abstract Abstract 1727 Background: Myelofibrosis (MF) is characterized by cytopenias, splenomegaly, and burdensome symptoms that may worsen over time. Ruxolitinib (RUX) has been shown to reduce splenomegaly and improve MF-associated symptoms in 2 phase III studies, including COMFORT-I, a randomized, double-blind, placebo (PBO)-controlled trial, which also showed prolonged survival in favor of RUX. Purpose: In this post hoc analysis of COMFORT-I, the efficacy of RUX in patients with varying degrees of splenomegaly and symptom severity at baseline was evaluated to assess the potential effects of earlier versus later intervention in this progressive disease. Methods: COMFORT-I participants randomized to RUX (n=155) or PBO (n=154) had MF with an International Prognostic Scoring System (IPSS) score ≥2 and a platelet count of ≥100 × 109/L. Patients with protocol-defined worsening splenomegaly were permitted to cross over from PBO to RUX. The primary endpoint was the percentage of patients with ≥35% reduction in spleen volume (SV) at week (wk) 24. Change in Total Symptom Score (TSS) was a secondary endpoint. TSS was the sum of 6 symptom scores (night sweats, itching, abdominal discomfort, pain under ribs on left side, early satiety, muscle/bone pain) assessed with the modified MF Symptom Assessment Form (MFSAF) v2.0 on a scale of 0 (“absent”) to 10 (“worst imaginable”). Patients were stratified by palpable spleen length (SL) (≤ 10 cm, <10 to 20 cm, >20 cm) and TSS tertile (≤11.1, >11.1 to 22.0, >22.0) at baseline. SV and TSS stratified by baseline values as described were summarized over time. To account for PBO crossover, modeling was performed to predict SV after crossover using a nonlinear mixed model that best predicted individual patient data. Last observation carried forward was used to impute missing TSS data. Results: Mean absolute SV and TSS worsened over time in the PBO group regardless of baseline SL and TSS, demonstrating the progressive nature of MF. In patients treated with RUX, mean absolute SV and TSS at wk 24 were lower for patients with smaller SL and less severe TSS at baseline, respectively (Table); absolute differences with PBO were significant within each subgroup. Therefore, patients who initiated RUX therapy with more advanced MF were less likely to achieve the same clinical status experienced by patients initiating therapy with less advanced MF. Notably, even after 24 wks of RUX treatment, SV and TSS reductions in the cohorts with larger SL or greater TSS at baseline did not achieve levels equivalent to baseline of the next lesser baseline severity group (Table; Figure). Although the severity of splenomegaly and symptoms at baseline influenced the absolute SV and TSS achieved at wk 24, RUX treatment resulted in similar percent reductions in SV and improvements TSS across all subgroups, with the exception of the lower TSS tertile (where there is less room for improvement). In contrast, PBO treatment resulted in increases in SV and worsening of symptoms and patients with less severe SV and TSS at baseline experienced the greatest percent increases in SV and TSS at wk 24. Conclusions: RUX therapy was associated with SV reduction and symptom improvement regardless of spleen size or symptom severity at baseline, whereas patients on PBO experienced disease progression across all subgroups. Patients receiving RUX with less advanced disease achieved an overall better clinical status, as defined by lower absolute SV and symptom scores. This analysis suggests that initiation of RUX in patients with less severe splenomegaly and symptoms may contribute to improved patient outcomes. Disclosures: Mesa: Incyte: Research Funding; Lilly: Research Funding; Sanofi: Research Funding; NS Pharma: Research Funding; YM Bioscience: Research Funding. Gotlib:Incyte: Consultancy. Kantarjian:Incyte: grant support Other. Sun:Incyte: Employment. Verstovsek:Incyte Corporation: Research Funding.

scholarly journals Functional neurological symptoms

2015 ◽  
Author(s):  
Alan Carson ◽  
Jon Stone
Keyword(s):  
Functional Neuroimaging ◽  
Controlled Trial ◽  
Epileptic Seizures ◽  
Conversion Disorder ◽  
Neurological Symptoms ◽  
Clinical Neurology ◽  
Current Time ◽  
Randomized Controlled ◽  
Functional Neurological Symptoms ◽  
Over Time

Functional neurological symptoms are a common cause of disability and distress in any neurological service. Varying terminology, including hysteria, conversion disorder, dissociative, non-organic, and psychogenic, reflects the shifting nature of medical thinking, over time, regarding these presentations. They also emphasize the importance of a historical understanding when grappling with this area. This chapter traces this history, from Briquet’s monumental treatise on hysteria in 1859 to a randomized controlled trial of non-epileptic seizures in 2010. In the process, familiar figures such as Freud and Janet are encountered and the electrical treatments of Yealland, for hysteria, are re-evaluated. The chapter highlights how the application of functional neuroimaging perhaps raises more questions than it answers, at the current time, but how it has also aided the reawakening of clinical and research interest in this core area of clinical neurology.

scholarly journals Study protocol for a non-inferiority randomised controlled trial of SKY breathing meditation versus cognitive processing therapy for PTSD among veterans

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e027150 ◽  
Author(s):  
Danielle C Mathersul ◽  
Julia S Tang ◽  
R Jay Schulz-Heik ◽  
Timothy J Avery ◽  
Emma M Seppälä ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Processing ◽  
Controlled Trial ◽  
Self Report ◽  
Cognitive Processing Therapy ◽  
Symptom Improvement ◽  
Evidence Based ◽  
Post Traumatic Stress ◽  
Randomised Controlled ◽  
Breathing Meditation

IntroductionPost-traumatic stress disorder (PTSD) is a debilitating, highly prevalent condition. Current clinical practice guidelines recommend trauma-focused psychotherapy (eg, cognitive processing therapy; CPT) as the first-line treatment for PTSD. However, while these treatments show clinically meaningful symptom improvement, the majority of those who begin treatment retain a diagnosis of PTSD post-treatment. Perhaps for this reason, many individuals with PTSD have sought more holistic, mind–body, complementary and integrative health (CIH) interventions. However, there remains a paucity of high-quality, active controlled efficacy studies of CIH interventions for PTSD, which precludes their formal recommendation.Methods and analysesWe present the protocol for an ongoing non-inferiority parallel group randomised controlled trial (RCT) comparing the efficacy of a breathing meditation intervention (Sudarshan Kriya Yoga [SKY]) to a recommended evidence-based psychotherapy (CPT) for PTSD among veterans. Assessors are blinded to treatment group. The primary outcome measure is the PTSD Checklist-Civilian Version and a combination of clinical, self-report, experimental and physiological outcome measures assess treatment-related changes across each of the four PTSD symptom clusters (re-experiencing, avoidance, negative cognitions or mood and hyperarousal/reactivity). Once the RCT is completed, analyses will use both an intent-to-treat (using the ‘last observation carried forward’ for missing data) and a per-protocol or ‘treatment completers’ procedure, which is the most rigorous approach to non-inferiority designs.Ethics and disseminationTo the best of our knowledge, this is this first non-inferiority RCT of SKY versus CPT for PTSD among veterans. The protocol is approved by the Stanford University Institutional Review Board. All participants provided written informed consent prior to participation. Results from this RCT will inform future studies including larger multi-site efficacy RCTs of SKY for PTSD and other mental health conditions, as well as exploration of cost-effectiveness and evaluation of implementation issues. Results will also inform evidence-based formal recommendations regarding CIH interventions for PTSD.Trial registration numberNCT02366403; Pre-results.

scholarly journals Investigating patient-specific mechanisms of change in SET vs. EFT for depression: study protocol for a mechanistic randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sigal Zilcha-Mano ◽  
Ben Shahar ◽  
Hadar Fisher ◽  
Tohar Dolev-Amit ◽  
Leslie S. Greenberg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Emotional Processing ◽  
Rating Scale ◽  
Controlled Trial ◽  
Self Report ◽  
Main Mechanism ◽  
Patient Specific ◽  
Mechanisms Of Change ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Major depressive disorder (MDD) is the leading cause of disability worldwide and one of the most heterogeneous mental health disorders. Although there are effective treatments for MDD, about 50% of patients do not respond to treatment. One of the greatest challenges in improving current treatments is identifying the mechanisms responsible for therapeutic change in MDD. The proposed study aims to identify patient-specific mechanisms of change in two treatments for MDD by investigating whether subpopulations of patients differ in the mechanisms of change that operate when receiving a given treatment. Based on theories of targeting weakness and building on strength, we will examine whether the mechanism of change operating when a treatment is provided depends on whether the treatment targets the patient’s strength or weakness. Method To test our hypothesis that two treatments, supportive-expressive treatment (SET) and emotion-focused treatment (EFT), differ in their mechanisms of change and to explore whether focusing on the patient’s strength or weakness will result in better treatment outcome, we conduct a mechanistic randomized controlled trial. One hundred and twenty-four individuals diagnosed with MDD are randomized to 16 sessions of either SET or EFT. The two treatments are theorized to differ in their main mechanism of change: SET places emphasis on insight as its main mechanism of change, and EFT places emphasis on emotional processing. Both can serve as strength- or weakness-focused treatments, based on the patient’s baseline levels of insight and emotional processing. The primary outcome is the Hamilton Rating Scale for Depression. Additional measures include self-report measures and clinical interviews, hormonal, motion, acoustic, physiological, and neuroimaging assessments, performance on cognitive tasks, and narrative material (collected from the sessions and interviews). Discussion The RCT will expand our understanding of mechanisms of change in psychotherapy, from one-size-fits-all to patient-specific mechanisms of change. By informing therapists about which of the two approaches is most effective with patients based on their baseline characteristics, the RCT will contribute to progress toward personalized treatment. Trial registration clinicaltrials.gov Identifier: NCT04576182 submitted on October 1st 2020. Funding: The Israel Science Foundation. Trial status: Recruitment is ongoing.

scholarly journals Study protocol: developing and evaluating an interactive web platform to teach children hunting, shooting and firearms safety: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David C. Schwebel ◽  
D. Leann Long ◽  
Marissa Gowey ◽  
Joan Severson ◽  
Yefei He ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Impulse Control ◽  
Cognitive Skills ◽  
Controlled Trial ◽  
The United States ◽  
Self Report ◽  
Basic Knowledge ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Firearms injuries present a major pediatric public health challenge in the United States. This study protocol describes research to develop and then conduct a randomized clinical trial to evaluate ShootSafe, an interactive, engaging, educational website to teach children firearms safety. ShootSafe has three primary goals: (a) teach children basic knowledge and skills needed to hunt, shoot, and use firearms safely; (b) help children learn and hone critical cognitive skills of impulse control and hypothetical thinking needed to use firearms safely; and (c) alter children’s perceptions about their own vulnerability and susceptibility to firearms-related injuries, the severity of those injuries, and their perceived norms about peer behavior surrounding firearms use. ShootSafe will accomplish these goals through a combination of interactive games plus short, impactful testimonial videos and short expert-led educational videos. Methods Following website development, ShootSafe will be evaluated through a randomized controlled trial with 162 children ages 10–12, randomly assigning children to engage in ShootSafe or an active control website. Multiple self-report, computer-based, and behavioral measures will assess functioning at baseline, immediately following training, and at 4-month follow-up. Four sets of outcomes will be considered: firearms safety knowledge; cognitive skills in impulse control and hypothetical thinking; perceptions about firearms safety; and simulated behavior when handling, storing and transporting firearms. Training in both conditions will comprise two 45-min sessions. Discussion If results are as hypothesized, ShootSafe offers potential as a theory-based program to teach children firearms safety in an accessible, engaging and educational manner. Translation into practice is highly feasible. Trial registration The study protocol was registered on 11/10/20 at clinicaltrials.gov (NCT04622943).

Slow-Stroke Back Massage Compared With Music Therapy for Leukemia-Related Pain and Fatigue: A Randomized Controlled Trial

2021 ◽  
pp. OP.21.00156
Author(s):  
Mojtaba Miladinia ◽  
Joachim G. Voss ◽  
Shahram Molavynejad ◽  
Amal Saki Malehi ◽  
Kourosh Zarea ◽  
...  
Keyword(s):  
Acute Leukemia ◽  
Music Therapy ◽  
Standard Care ◽  
Rating Scales ◽  
Controlled Trial ◽  
Adult Patients ◽  
Self Report ◽  
Care Group ◽  
Control Group ◽  
Over Time

PURPOSE: Comparison of two safe complementary medicine methods to treat cancer-related pain and fatigue in adult patients with acute leukemia during active treatment with chemotherapy. METHODS: A randomized trial with three groups (light massage, music therapy, and standard care) in Ahvaz, Iran, between 2018 and 2019. A total of 104 participants of the massage and music therapy groups received 15-minute intervention sessions, thrice weekly for 4 weeks, and participants of the control group received standard care. Cancer-related pain and fatigue intensity were measured by numeric self-report rating scales. During the 4 weeks of the interventions, pain and fatigue intensity were measured weekly. All the groups were followed up for 2 weeks after the end of the intervention. RESULTS: Pain and fatigue intensity decreased significantly over time between the intervention groups compared with the standard care group. In the massage and music therapy groups, a progressive reduction of pain and fatigue intensity over time (from the baseline to the fourth week) was observed. Fatigue intensity did not differ between the two intervention groups. Pain intensity decreased more in the massage group compared with the music therapy group. The durable effects of the massage therapy were greater compared with the music therapy 2 weeks after the intervention was completed. CONCLUSION: Light massage was more effective and persisted longer than the music therapy for controlling leukemia-related pain and fatigue in adult patients with acute leukemia.

scholarly journals Adults Who Are Overweight or Obese and Consuming an Energy-Restricted Healthy US-Style Eating Pattern at Either the Recommended or a Higher Protein Quantity Perceive a Shift from “Poor” to “Good” Sleep: A Randomized Controlled Trial

2020 ◽  
Vol 150 (12) ◽  
pp. 3216-3223
Author(s):  
Joshua L Hudson ◽  
Jing Zhou ◽  
Wayne W Campbell
Keyword(s):  
Sleep Quality ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Energy Restriction ◽  
Sleep Onset Latency ◽  
Quality Indices ◽  
Eating Pattern ◽  
Good Sleep ◽  
Over Time

ABSTRACT Background Limited evidence suggests that consuming a higher-protein diet during weight loss improves subjective indices of sleep in overweight and obese adults. Objective We sought to a priori assess the effects of consuming the recommended versus a higher protein Healthy US-Style Eating Pattern during energy-restriction on sleep quality indices. Design Using a randomized, parallel study design, 51 adults (mean ± SEM age: 47 ± 1 y; BMI: 32.6 ± 0.5 kg/m2) consumed a controlled USDA Healthy US-Style Eating Pattern containing 750 kcal/d less than their estimated energy requirement for 12 wk. Participants were randomly assigned to consume either 5 or 12.5 oz-equivalent (eq)/d of protein foods. The additional 7.5 oz-eq/d came from animal-based protein sources and displaced primarily grains. Objective (wrist-worn actigraphy) and subjective (Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale) sleep quality indices were measured at baseline, week 6, and week 12. Results Among all participants, body mass decreased (−6.2 ± 0.4 kg). Dietary protein intake did not affect any objective or subjective sleep quality outcomes measured (repeated measures ANOVA). Over time, objective measures of time spent in bed, time spent sleeping, sleep onset latency, and time awake after sleep onset did not change; however, sleep efficiency improved (1 ± 1%; P = 0.027). Subjectively, global sleep scores [GSS: −2.7 ± 0.4 arbitrary units (au)] and daytime sleepiness scores (−3.8 ± 0.4 au; both P &lt; 0.001) improved over time. The GSS improvement transitioned the participants from being categorized with “poor” to “good” sleep (GSS: &gt;5 compared with ≤5 au of a 0–21 au scale; baseline 7.6 ± 0.4 au, week 12: 4.8 ± 0.4 au). Conclusions Although objective sleep quality may not improve, adults who are overweight or obese and poor sleepers may become good sleepers while consuming either the recommended or a higher-protein energy-restricted Healthy US-Style Eating Pattern. This trial was registered at clinicaltrials.gov as NCT03174769.

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