Clinical trial NCT02787577: The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study
Official title: The SLuMBER Study: The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Sleep Duration
Sleep Quality
Body Composition
Energy Intake
Energy Expenditure
Energy Balance
Cardiovascular Risk
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Short sleep duration has been associated with increased risk of weight gain and development of non-communicable diseases. Sleep deprivation studies have suggested the link between restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal. However, the severity and acuteness of sleep restriction schedules in laboratory-based studies could hinder the ecological validity of the findings. The pragmatic way forward is to assess how improved sleep in habitually short sleepers impacts the aforementioned outcomes. This study assesses the feasibility of lengthening sleep in short sleepers, as well as how improved sleep duration and/or quality impact metabolic health, body composition, energy balance and cardiovascular risk.

Detailed description: Research Questions

* Is it feasible to improve sleep duration and quality in habitually short sleepers under free-living conditions?
* What are the effects of improved sleep duration and quality on body composition, energy balance, dietary intake, and cardio-metabolic risk factors?

Hypothesis

- Improved sleep duration and/or quality in habitually short sleepers will result in improved energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Aims

* To assess the feasibility of improving sleep duration and/or quality in habitually short sleepers using behavioural approaches and public health messages targeting sleep hygiene.
* To identify how improved sleep duration and/or quality affect energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Objectives

1. To develop a sleep extension strategy using behaviour change techniques (BCTs) targeting sleep hygiene.
2. To recruit healthy adults who are habitually short sleepers and randomise eligible participants to an intervention and control group.
3. To assess the feasibility and effectiveness of the intervention.
4. To measure energy balance, diet quality, body composition and cardio-metabolic risk factors pre- and post-treatment in the intervention and control groups.
5. To assess whether the intervention had an effect on the aforementioned parameters by comparing the intervention endpoints to control as well as baseline measures.
6. To run the statistical analysis both on an intention-to-treat basis as well as per-protocol.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults (18-64 years)
* Habitually short sleepers (5-\<7 hours of sleep per night on average on weekdays) - this is self-reported at screening, and confirmed by actigraphy when baseline measurement is taken.
* BMI: 18.5 - \<30

Exclusion Criteria:

* Diagnosed medical conditions such as:
* Cardiovascular disease
* Type 1 or Type 2 Diabetes Mellitus
* Cancer (excluding basal carcinoma) in the past five years
* Chronic renal or liver disease
* Inflammatory bowel disease
* Hypo/hyperthyroidism
* Sleep conditions:
* Chronic use of sleeping aid medication
* Insomnia (Insomnia Severity Index - ISI Questionnaire)
* Sleep apnoea (Berlin Questionnaire)
* Extreme Chronotype (HorneOstberg questionnaire)
* Pregnancy or lactation
* Weight change of \>3 kg in the previous two months
* Previous or current high alcohol intake (\>28 units/week for males and \>21 units/week for females) or substance abuse
* Smoking
* Working hours outside 7 am - 7 pm
* Habitual napping (\>20 minutes per day on a regular basis)
* Obliged to wake and care for family/friends (e.g. new born child etc)
* Use of antidepressants
* Depressed mood (Center of Epidemiologic Studies of Depression 20-item scale questionnaire)
* Travel arrangements outside time zone within the periods of data collection
* Travel arrangements outside time zone within period of intervention/control condition
* Inability to adhere to a sleep hygiene intervention/sleep schedule due to time commitments

Primary outcomes:
measure: Sleep Duration
timeFrame: baseline
measure: Sleep Duration
timeFrame: week 4
measure: Sleep Quality
timeFrame: baseline
measure: Sleep Quality
timeFrame: week 4
Secondary outcomes:
measure: BMI
timeFrame: baseline
measure: BMI
timeFrame: day 28
measure: Body fat percentage
timeFrame: baseline
measure: Body fat percentage
timeFrame: day 28
measure: Blood pressure
timeFrame: baseline
measure: Blood pressure
timeFrame: day 28
measure: Fasting blood glucose
timeFrame: baseline
measure: Fasting blood glucose
timeFrame: day 28
measure: Fasting total cholesterol
timeFrame: baseline
measure: Fasting HDL cholesterol
timeFrame: baseline
measure: Fasting LDL cholesterol
timeFrame: baseline
measure: Fasting triglycerides
timeFrame: baseline
measure: Fasting total cholesterol
timeFrame: day 28
measure: Fasting HDL cholesterol
timeFrame: day 28
measure: Fasting LDL cholesterol
timeFrame: day 28
measure: Fasting triglycerides
timeFrame: day 28
measure: plasma leptin
timeFrame: baseline
measure: plasma leptin
timeFrame: day 28
measure: plasma ghrelin
timeFrame: baseline
measure: plasma ghrelin
timeFrame: day 28
measure: plasma insulin
timeFrame: baseline
measure: plasma insulin
timeFrame: day 28
measure: plasma cortisol
timeFrame: baseline
measure: plasma cortisol
timeFrame: day 28
measure: Homeostasis model assessment estimated insulin resistance (HOMA-IR)
timeFrame: baseline
measure: Homeostasis model assessment estimated insulin resistance (HOMA-IR)
timeFrame: day 28
measure: Waist circumference
timeFrame: baseline
measure: Waist circumference
timeFrame: day 28
measure: Hip circumference
timeFrame: baseline
measure: Hip circumference
timeFrame: day 28
measure: Lean body mass
timeFrame: baseline
measure: Lean body mass
timeFrame: day 28
measure: Digital volume pulse - Stiffness Index (SI)
timeFrame: baseline
measure: Digital volume pulse - Stiffness Index (SI)
timeFrame: day 28
measure: Digital volume pulse - Reflection Index (RI)
timeFrame: baseline
measure: Digital volume pulse - Reflection Index (RI)
timeFrame: day 28
measure: Mnemonic Similarity Test (MST)
timeFrame: baseline
measure: Mnemonic Similarity Test (MST)
timeFrame: day 28
measure: Dietary Intake (7-day food diary)
timeFrame: baseline
measure: Dietary Intake (7-day food diary)
timeFrame: week 4
measure: Resting Metabolic Rate (RMR)
timeFrame: baseline
measure: Resting Metabolic Rate (RMR)
timeFrame: day 28
measure: Total Energy Expenditure (TEE)
timeFrame: baseline
measure: Total Energy Expenditure (TEE)
timeFrame: day 21-23
measure: Urinary 6-sulphatoxymelatonin
timeFrame: baseline
measure: Urinary 6-sulphatoxymelatonin
timeFrame: day 28
measure: Recent Physical Activity Questionnaire (RPAQ)
timeFrame: baseline
measure: Recent Physical Activity Questionnaire (RPAQ)
timeFrame: day 28
measure: Sleep Hygiene Index (SHI)
timeFrame: baseline
measure: Sleep Hygiene Index (SHI)
timeFrame: day 28
measure: Eating Choices Index (ECI)
timeFrame: baseline
measure: Eating Choices Index (ECI)
timeFrame: day 28
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: day 28
Other outcomes:
measure: Dutch Eating Behaviour Questionnaire (DEBQ)
timeFrame: baseline
measure: Women's Health Questionnaire
timeFrame: baseline
measure: Women's Health Questionnaire
timeFrame: day 21
Locations:
city: London
country: United Kingdom
facility: Diabetes & Nutritional Sciences Division, King's College London
Study officials:
affiliation: King's College London
name: Wendy Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosy-Westphal A, Hinrichs S, Jauch-Chara K, Hitze B, Later W, Wilms B, Settler U, Peters A, Kiosz D, Muller MJ. Influence of partial sleep deprivation on energy balance and insulin sensitivity in healthy women. Obes Facts. 2008;1(5):266-73. doi: 10.1159/000158874. Epub 2008 Oct 23.
citation: Brondel L, Romer MA, Nougues PM, Touyarou P, Davenne D. Acute partial sleep deprivation increases food intake in healthy men. Am J Clin Nutr. 2010 Jun;91(6):1550-9. doi: 10.3945/ajcn.2009.28523. Epub 2010 Mar 31.
citation: Buxton OM, Pavlova M, Reid EW, Wang W, Simonson DC, Adler GK. Sleep restriction for 1 week reduces insulin sensitivity in healthy men. Diabetes. 2010 Sep;59(9):2126-33. doi: 10.2337/db09-0699. Epub 2010 Jun 28.
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citation: Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. doi: 10.1016/S0140-6736(99)01376-8.
citation: St-Onge MP, Roberts AL, Chen J, Kelleman M, O'Keeffe M, RoyChoudhury A, Jones PJ. Short sleep duration increases energy intakes but does not change energy expenditure in normal-weight individuals. Am J Clin Nutr. 2011 Aug;94(2):410-6. doi: 10.3945/ajcn.111.013904. Epub 2011 Jun 29.
citation: St-Onge MP, O'Keeffe M, Roberts AL, RoyChoudhury A, Laferrere B. Short sleep duration, glucose dysregulation and hormonal regulation of appetite in men and women. Sleep. 2012 Nov 1;35(11):1503-10. doi: 10.5665/sleep.2198.
citation: Al Khatib HK, Hall WL, Creedon A, Ooi E, Masri T, McGowan L, Harding SV, Darzi J, Pot GK. Sleep extension is a feasible lifestyle intervention in free-living adults who are habitually short sleepers: a potential strategy for decreasing intake of free sugars? A randomized controlled pilot study. Am J Clin Nutr. 2018 Jan 1;107(1):43-53. doi: 10.1093/ajcn/nqx030.