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Clinical Trial Summary

This interventional, double-blind, randomized, placebo-controlled pilot study aims to evaluate the effect of a dietary supplementation of a fish hydrolysate Peptidyss on sleep quality and anxiety.


Clinical Trial Description

A total of 44 healthy participants (n=22 female, n=22 male) aged 35-60 years inclusive are included into the study, in a cross-over design. The participants will take both products, the fish hydrolysate Peptidyss and the placebo during a period of 4 weeks per product. The total duration of the study per participant is 127 days. The study visits are defined as Screening Visit and Study Inclusion (V0), Pre-Intervention-1-Visit (V1), Post-Intervention-1-Visit (V2), Follow-up-Intervention-1-Visit / Pre-Intervention-2-Visit (V3), Post-Intervention-2-Visit (V4) and Follow-up-Intervention-2-Visit (V5). The 4 weeks between V2 and V3 will serve as a washout phase between Intervention-1 and Intervention-2. No further follow-up visit is planned. The primary objective is to evaluate the efficacy of Peptidyss® on sleep quality. The secondary objectives are to evaluate the efficacy of Peptidyss® on sleep quality, anxiety, perceived stress and quality of life. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04983355
Study type Interventional
Source Abyss Ingredients
Contact
Status Completed
Phase N/A
Start date July 19, 2021
Completion date January 25, 2022

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