Effects of exercise and diet interventions on obesity-related sleep disorders in men: study protocol for a randomized controlled trial

Abstract

BackgroundSleep 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/designParticipants 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.DiscussionIt 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.Trial registrationCurrent Controlled Trials ISRCTN77172005

Effects of aerobic exercise on home-based sleep among overweight and obese men with chronic insomnia symptoms: a randomized controlled trial

“…The present two-arm randomized controlled trial forms part of a larger study on the effects of different lifestyle interventions on obesity-related sleep disorders (ISRCTN77172005) [12]. The participant flow is depicted in Fig.…”

“…After the baseline measurements, participants were randomized into the 6-month exercise intervention, 6-month diet intervention, or control group according to a case-matched computergenerated randomization, stratified for age and BMI [12]. This study reports comparisons between the exercise and control groups only.…”

Exercise has the guts: How physical activity may positively modulate gut microbiota in chronic and immune-based diseases

“…It is yet unsolved whether weight loss causes gut microbiota modifications or vice versa. In obese individuals with sleep disorders, a 6-month individual progressive exercise program, combining Nordic walking, stretching, strength, relaxation, together with dietary suggestions, improved sleep quality and modified gut microbiota composition [110]. It has been speculated that even Tai-chi, as a form of moderate-intensity exercise involving deep breathing and meditation, might induce favorable changes in gut microbiota by mediating the HPA axis [111].…”

Associations of disordered sleep with body fat distribution, physical activity and diet among overweight middle‐aged men

“…This is an exploratory ancillary study, based on the baseline data of a randomized controlled lifestyle intervention trial for middle-aged men with sleep disorders (the MOTOSD study, ISRCTN77172005) (Tan et al, 2013). Participants for this study comprised a total of 211 Finnish men aged 30-65 years who resided in the city of Jyv€ askyl€ a and its surroundings with a population of 150 000 inhabitants.…”

“…All food consumption data were analysed from a 3-day food diary and detailed information was reported elsewhere (Tan et al, 2013). Briefly, a food diary was kept for a period including 2 working days and 1 weekend day.…”