Healthy adults with dissatisfaction with their current sleep Mental and Behavioural Disorders
Conditions
Interventions
An 8-week placebo-controlled intervention where participants will be randomised to either a placebo or active treatment regime. Participants will be randomised with the use of a Latin square. Treatmen
Sponsors
Newcastle University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 65 years 2. Adults who are dissatisfied with their current sleep
Exclusion criteria
Exclusion criteria: 1. Individuals who report any sleep-related supplement use such as Ashwagandha, Magnesium, Calms, Nytol etc. 2. Allergies to any foods 3. Pregnant, trying to become pregnant or lactating 4. History of gastrointestinal disease or conditions 5. Use of antibiotics within the last 1 month 6. Any clinical condition which could impact sleep such as pulmonary and cardiovascular disorders. 7. Use of opioids or other drugs which could impact digestive transit within the last 1 month 8. Clinical sleep disturbance 9. External disturbances of sleep patterns such us living in a noisy environment or caring for small children 10. Night shift workers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality measured using the Pittsburgh Sleep Quality Index at baseline and weeks 2, 4, 6, and 8 post supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sleep and physical activity measured using an actiwatch device worn on the non-dominant wrist for the duration of the study. Mean weekly data will be used for analysis. Outcomes will include: 1.1. Sleep onset latency 1.2. Total sleep time (recorded minutes asleep over entire sleep period) 1.3. Number of awakenings 1.4. Wake after sleep onset (recorded minutes awake during the entire sleep period following sleep onset) Measured at baseline, weeks 1, 2, 3, 4, 5, 6, 7, and 8 post supplementation 2. Depression and anxiety measured using the Patient Health Questionnaire and General Anxiety Disorder questionnaires at baseline and weeks 2, 4, 6, 8 post supplementation 3. Digestive health assessed using the Gastrointestinal Symptom Rating Scale and Bristol Stool Chart at baseline and weeks 2, 4, 6, and 8 post supplementation 4. Quality of life measured using a series of questions and electronic visual analogue scales (including concentration, general mood, positivity etc) at baseline and weeks 2, 4, 6, 8 post dose Other pre-specified outcome measures: 5. Habitual diet measured using the Epic Norfolk Food Frequency Questionnaire at baseline and 4, 8 weeks post supplementation 6. Menstrual cycle phase measured using the Menstrual Phase Identification Questionnaire (MPIQ) in women only at baseline and weeks 2, 4, 6, and 8, post supplementation 7. Demographics and lifestyle questionnaires at baseline 8. Self-reported anthropometric measurements including height and weight at baseline and 8 weeks post supplementation 9. Compliance with study protocol qualitatively evaluated by questionnaire at baseline and weeks 1, 2, 3, 4, 5, 6, 7, and 8 post supplementation 10. Stool microbiome measured using 16s rRNA sequencing at baseline and 8 weeks 8 post supplementation 11. Saliva cortisol measured using enzyme-linked immunosorbent assay at baseline and 8 weeks 8 post supplementation | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactAnthony Watson
Outcome results
None listed