SMART Study: Sleep, Microbiota And fRuiT Study

Not Applicable

Withdrawn

• Conditions: Poor sleep; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12620000411943
• Lead Sponsor: Massey University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-27
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Healthy males
Aged between 18-45 years of age
Body mass index (BMI) (18.5-30kg/m2)
Physically active but no more than 2 hours per day
Poor sleepers, defined as having an ISI (Insomnia Severity Index) score of >8 (Ree, Pollitt, & Harvey, 2006) and the Pittsburgh Sleep Quality Index (PSQI) score >5 (Buysse, Reynolds III, Monk, Berman, & Kupfer, 1988)
Glycated haemoglobin (HbA1c) test, value <41mmol/mol (greater than this is considered prediabetes) (Braatvedt et al., 2012)

Exclusion Criteria

Use of specific prescribed medication as listed below or recreational drugs use:
Diuretics, Oral or inhaled steroids, Cholinergic antispasmodics, Lactulose, Metamucil, Antibiotics, Sedative/hypnotic medication, Laxatives, Antacids, Cholesterol-lowering medications, Proton pump inhibitors (acid reflux treatments), Vitamin/mineral supplements, Heparin, Antidepressants
Excessive alcohol intake defined as >20g of pure alcohol (2 drinks)/d on average. (>21 standard drinks a week)
Smoke cigarettes
History of gastrointestinal surgery or gastrointestinal disorders including inflammatory bowel disease (IBD), ulcerative colitis, coeliac disease, Crohn’s disease
Medical conditions (e.g., cardiorespiratory, diabetes mellitus, bleeding disorders)
Psychiatric conditions (e.g., Major depressive disorder, Schizophrenia)
Antibiotic consumption (1 month before the study and during the study)
Significant weight loss during the past six months
Being on a controlled diet or dietary weight loss regimen within four weeks before and during the study
Vegetarian/vegan
Aversion to blood sampling
Allergies to dairy products or eggs or fruits
Participants will be asked to abstain from alcohol before attending a sleep session at the laboratory and to abstain from caffeinated beverages and vigorous exercise eight hours before their averaged bedtimes
Diagnosed with or symptoms of COVID-19

Study & Design

• Study Type: Interventional
• Study Design: Not specified