Article ; Online: Efficacy of a fish hydrolysate supplement on sleep quality: A randomized, double-blind, placebo-controlled, crossover clinical trial.
Clinical nutrition ESPEN
2024 Volume 60, Page(s) 48–58
Abstract: Background & aims: Sleep disturbances are widespread in modern societies and linked to a variety of diseases, creating an urgent need for the development of products that help combat sleep difficulties. One suitable nutritional supplement may be a fish ... ...
| Abstract | Background & aims: Sleep disturbances are widespread in modern societies and linked to a variety of diseases, creating an urgent need for the development of products that help combat sleep difficulties. One suitable nutritional supplement may be a fish hydrolysate composed of low molecular weight peptides. Methods: This two-arm, double-blind, randomized, placebo-controlled crossover study investigated the effect of a 4-week fish hydrolysate intervention on sleep in a healthy German population reporting poor sleep quality, assessed with the Pittsburgh Sleep Quality Index (PSQI). Further sleep parameters were measured using an online diary and a wrist wearable device. Additionally, questionnaires related to stress, anxiety, depression, and well-being were evaluated and salivary cortisol and product satisfaction were assessed. Results: The 4-week fish hydrolysate supplementation significantly improved subjective sleep quality measured with the PSQI-score (p = .002). Moreover, individuals reported improvements in sleep efficacy and a reduction in sleep disturbances and daytime sleepiness during fish hydrolysate intake (p = .013, p = .046, p = .004 respectively), but not during placebo phase (all p > .05). No significant intra-individual differences were found between fish hydrolysate and placebo supplementation (p > .05). Conclusions: Although no significant intra-individual differences were found between fish hydrolysate and placebo supplementation, the significant improvement in subjective sleep quality from baseline to treatment phase suggests that fish hydrolysate is a safe nutritional supplement to support individuals with self-reported sleep problems. Clinical trial registration: The study is registered at ClinicalTrials.gov with the Identifier NCT04983355. |
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| MeSH term(s) | Humans ; Sleep Quality ; Cross-Over Studies ; Treatment Outcome ; Sleep ; Sleep Initiation and Maintenance Disorders ; Dietary Supplements |
| Language | English |
| Publishing date | 2024-01-13 |
| Publishing country | England |
| Document type | Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't |
| ISSN | 2405-4577 |
| ISSN (online) | 2405-4577 |
| DOI | 10.1016/j.clnesp.2024.01.002 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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