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

NCT04983355 | Completed

• 1 other identifier: PEPTIDYSS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleep disorder; anxiety; stress; fish hydrolysate; food supplement

Outcome Measures

Primary Outcomes (1)

• Evaluation of sleep quality

  Measured with the Pittsburgh Sleep Quality Index (PSQI) at each visit

  18 weeks

Secondary Outcomes (6)

• Duration of sleep

  18 weeks

• Evaluation of anxiety

  18 weeks

• Evaluation of perceived stress

  18 weeks

• Evaluation of depression, anxiety and stress

  18 weeks

• Evaluation of quality of life

  18 weeks

Other Outcomes (1)

• Evaluation of salivary cortisol

  18 weeks

Study Arms (2)

Peptidyss

EXPERIMENTAL

Dietary supplement : fish hydrolysate The experimental product is a dietary supplement composed of a hydrolysate of fish containing low molecular weight peptides (4 capsules/day providing 1,4 g of fish hydrolysate)

Dietary Supplement: Fish Hydrolysate

Placebo

PLACEBO COMPARATOR

The placebo product containing mainly silica is presented in the same form as the active product, so that people handling the product cannot distinguish both formula (4 capsules/day)

Dietary Supplement: Placebo

Interventions

Fish Hydrolysate DIETARY_SUPPLEMENT

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.

Peptidyss

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abyss Ingredients: lead
• Daacro: collaborator

Study Sites (1)

daacro GmbH & Co. KG

Trier, 54296, Germany

Location

Related Publications (1)

• Eckert F, Meyer N, Monzel E, Bouvret E, Chataigner M, Hellhammer J. Efficacy of a fish hydrolysate supplement on sleep quality: A randomized, double-blind, placebo-controlled, crossover clinical trial. Clin Nutr ESPEN. 2024 Apr;60:48-58. doi: 10.1016/j.clnesp.2024.01.002. Epub 2024 Jan 13.

  PMID: 38479939 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Juliane Hellhammer, PhD

  Daacro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 30, 2021
• Study Start: July 19, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 25, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

DE (1)