MedTrace Logo

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

NCT04983355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-08-17

No results posted yet for this study

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.

Conditions

  • Sleep Disorder

Interventions

DIETARY_SUPPLEMENT

Fish Hydrolysate

The participants take 4 capsules/day of the study product. Two capsules should be consumed orally every morning with breakfast and/or with a glass of (plain, not sparkling) water and not with fruit juice or hot food/drink while ingesting the capsules; and two capsules should be consumed orally every evening with their dinner and/or with a glass of water. Participants receiving the fish hydrolysate the fourth first weeks will then receive the placebo during another 4 weeks. A wash-out period of 4 weeks is included between each phase of supplementation.

DIETARY_SUPPLEMENT

Placebo

The participants take 4 capsules/day of the study product. Two capsules should be consumed orally every morning with breakfast and/or with a glass of (plain, not sparkling) water and not with fruit juice or hot food/drink while ingesting the capsules; and two capsules should be consumed orally every evening with their dinner and/or with a glass of water. Participants receiving the Placebo the fourth first weeks will then receive the fish hydrolysate during another 4 weeks. A wash-out period of 4 weeks is included between each phase of supplementation.

Sponsors & Collaborators

  • Daacro

    collaborator NETWORK

  • Abyss Ingredients

    lead INDUSTRY

Principal Investigators

  • Juliane Hellhammer, PhD · Daacro

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2022-01-14
Completion
2022-01-25

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04983355 on ClinicalTrials.gov