title: Effects of exercise and diet interventions on obesity-related sleep disorders in men: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Sleep is essential for normal and healthy living. Lack of good quality sleep affects physical, mental and emotional functions. Currently, the treatments of obesity-related sleep disorders focus more on suppressing sleep-related symptoms pharmaceutically and are often accompanied by side effects. Thus, there is urgent need for alternative ways to combat chronic sleep disorders. This study will investigate underlying mechanisms of the effects of exercise and diet intervention on obesity-related sleep disorders, the role of gut microbiota in relation to poor quality of sleep and day-time sleepiness, as well as the levels of hormones responsible for sleep-wake cycle regulation.
  
  
  METHODS
  Participants consist of 330 (target sample) Finnish men aged 30 to 65 years. Among them, we attempt to randomize 180 (target sample) with sleep disorders into exercise and diet intervention. After screening and physician examination, 101 men with sleep disorders are included and are randomly assigned into three groups: exercise (n = 33), diet (n = 35), and control (n = 33). In addition, we attempt to recruit a target number of 150 healthy men without sleep disorders as the reference group. The exercise group undergoes a six-month individualized progressive aerobic exercise program based on initial fitness level. The diet group follows a six month specific individualized diet program. The control group and reference group are asked to maintain their normal activity and diet during intervention. Measurements are taken before and after the intervention. Primary outcomes include objective sleep measurements by polysomnography and a home-based non-contact sleep monitoring system, and subjective sleep evaluation by questionnaires. Secondary outcome measures include anthropometry, body composition, fitness, sleep disorder-related lifestyle risk factors, composition of gut microbiota and adipose tissue metabolism, as well as specific hormone and neurotranmitter levels and inflammatory biomarkers from venous blood samples.
  
  
  CONCLUSIONS
  It is expected that the improvement of sleep quality after exercise and diet intervention will be evident both in subjective and objective measures of quality of sleep. Additionally, the change of sleep quality induced by exercise and diet intervention is expected to be related to the changes in specific hormones and inflammatory biomarkers, and in the composition of gut microbiota.
authors.affiliation: Department of Health Sciences, University of Jyväskylä, Rautpohjankatu 8, PO Box 35, 40700 Jyväskylä, Finland.
authors.forename: Xiao
authors.initials: X
authors.lastname: Tan
authors.forename: Antti
authors.initials: A
authors.lastname: Saarinen
authors.forename: Tuija M
authors.initials: TM
authors.lastname: Mikkola
authors.forename: Jarkko
authors.initials: J
authors.lastname: Tenhunen
authors.forename: Samu
authors.initials: S
authors.lastname: Martinmäki
authors.forename: Aki
authors.initials: A
authors.lastname: Rahikainen
authors.forename: Shumei
authors.initials: S
authors.lastname: Cheng
authors.forename: Niklas
authors.initials: N
authors.lastname: Eklund
authors.forename: Satu
authors.initials: S
authors.lastname: Pekkala
authors.forename: Petri
authors.initials: P
authors.lastname: Wiklund
authors.forename: Eveliina
authors.initials: E
authors.lastname: Munukka
authors.forename: Xinfei
authors.initials: X
authors.lastname: Wen
authors.forename: Fengyu
authors.initials: F
authors.lastname: Cong
authors.forename: Xi
authors.initials: X
authors.lastname: Wang
authors.forename: Yajun
authors.initials: Y
authors.lastname: Zhang
authors.forename: Ina
authors.initials: I
authors.lastname: Tarkka
authors.forename: Yining
authors.initials: Y
authors.lastname: Sun
authors.forename: Markku
authors.initials: M
authors.lastname: Partinen
authors.forename: Markku
authors.initials: M
authors.lastname: Alen
authors.forename: Sulin
authors.initials: S
authors.lastname: Cheng
mesh_terms: D000328:Adult; D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D015415:Biomarkers / Q000097:blood; D004032:Diet; D005081:Exercise Therapy; D005387:Finland; D006728:Hormones / Q000097:blood; D018836:Inflammation Mediators / Q000097:blood; D007422:Intestines / Q000382:microbiology; D009765:Obesity / Q000150:complications / Q000175:diagnosis / Q000628:therapy; D017286:Polysomnography; D012107:Research Design; D040242:Risk Reduction Behavior; D012890:Sleep; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D007319:Sleep Initiation and Maintenance Disorders / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic
chemical_list: D015415:Biomarkers; D006728:Hormones; D018836:Inflammation Mediators