The Effects of a Nutritional Supplement on Sleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorAthletic Greens International
About this trial
This study is a randomized, double-blind, placebo-controlled study of N=140 adult men and women with sub-clinical sleep issues. This study to assess the effect of a novel dietary supplement on sleep related outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Be male or female
Be aged 35-65.
Body Mass Index: ≥18.5 and ≤29.9 kg/m2
Anyone currently experiencing issues with falling asleep, staying asleep, or waking up during the night
Disqualifiers
Anyone with a diagnosed chronic sleep condition, including but not limited to insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome (RLS), or sleep apnea.
Women currently undergoing perimenopause or experiencing vasomotor symptoms such as night sweats.
Use of hormone therapy (including estrogen, progesterone, or phytoestrogens) within the last 3 months.
Anyone with diagnosed psychiatric disorders including major depressive disorder with acute symptoms, Bipolar disorder, Generalized anxiety disorder with active symptoms, PTSD with frequent nightmares
Trial design
Design model
Parallel
Treatments tested in this trial
Novel powdered sleep supplement
Dietary supplementA dietary sleep supplement consisting of vitamins, minerals, adaptogens, and whole food ingredients
Placebo
Dietary supplementmaltodextrin placebo
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Novel Sleep SupplementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tracked sleep activity
Assessed via Oura ring
Time frame
42 days2
Sleep quality
Pittsburgh Sleep Quality Index and Restorative Sleep Questionnaire weekly
Time frame
Baseline, week 3, and week 6Secondary outcomes
1
Dietary habits
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Time frame
Baseline and endpoint (week 6)2
Oura Actigraphy - Daytime Activity
Daytime activity
Time frame
42 daysOther outcomes
1
Comprehensive Metabolic Blood Panel
Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium, ALT, AST, bilirubin, BUN, creatinine
Time frame
Baseline and endpoint (week 6)2
Complete blood count
Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
Time frame
Baseline and endpoint (week 6)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov