Efficacy of the Marine Based Nutritional Supplement Peptidyss® on Sleep and Anxiety

This is an interventional supportive care trial for Sleep Disorder focused on measuring sleep disorder, anxiety, stress, fish hydrolysate, food supplement Read More

Inclusion Criteria:

• Voluntary, written, informed consent to participate in the study
• Male or female aged between 35-60 years (inclusive)
• Body mass index (BMI) between ≥18.0 - ≤35.0 kg/m2
• PSQI score ≥6 (low perceived sleep quality)
• Medical questionnaire at baseline indicates they are healthy in the opinion of the Investigator
• Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects in the opinion of the Investigator
• Agreement to comply with the protocol and study restrictions
• Available for all study visits
• Agreement to refrain from heavy drinking, late-night alcohol and late-night caffeine during the study
• Females of child-bearing potential required to provide a negative urine pregnancy test
• Easy access to internet, using email on a daily basis.

Exclusion Criteria:

• Any known history of a disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS) or any condition which contraindicates, in the Investigator's judgement, entry to the study
• Self-reported diagnosis of one or more DSM-V axis 1 disorder(s), including but not limited to current depression, anxiety disorder, bipolar spectrum disorder or schizophrenia
• Have a significant acute or chronic coexisting illness or any condition which contraindicates entry to the study in the opinion of the Investigator
• Previous (last 4 weeks prior to screening) or current intake of psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers)
• History of use (within 1 month of the first visit) or current intake (from day of screening onwards) of medication or dietary supplements/oriental herbs that could influence sleep patterns or that the Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results (e.g. melatonin, omega-3 dietary supplements, non-steroidal anti-inflammatory drugs (NSAIDS), over-the-counter (OTC) sleep medication (not categorized as sedatives, hypnotics or anti-depressants), anti-coagulants, proton pump inhibitors, anti-histamines, pseudoephedrine, cortisone, beta-blockers)
• Self-declared illicit drug users (including cannabis and cocaine) for 3 months prior to screening and during the intervention period
• Heavy smoking (>10 cigarettes/day)
• High caffeine intake (> 10 cups /day) (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks),
• Work schedule that causes irregular sleep pattern (e.g. night shift)
• History of travel to a different time zone within 1 month of the first visit or/and during the study participation
• Pregnant or lactating female, or pregnancy planned during intervention period
• Not fluent in German
• Contraindication or allergy (e.g. fish allergy) to any substance in the investigational product
• Participation in another study with any investigational product within 30 days of screening and during the intervention period
• Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.