Sleep DisorderNCT04983355
Efficacy of the Marine Based Nutritional Supplement Peptidyss® on Sleep and Anxiety
A study testing Fish Hydrolysate in people with Sleep Disorder, run by Abyss Ingredients at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Fish Hydrolysate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jul 2021to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Marine Based Nutritional Supplement Peptidyss® on Sleep and Anxiety : a Randomized Clinical Trial With a Cross-Over Design in Healthy Adults
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.
Read the detailed 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.
- Conditions
- Sleep Disorder
- Being tested
- Fish Hydrolysate, Placebo
- Keywords
- sleep disorder, anxiety, stress, fish hydrolysate, food supplement
- Medical subject headings
- Sleep Wake Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish HydrolysateDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sleep quality
Measured with the Pittsburgh Sleep Quality Index (PSQI) at each visit
Measured: 18 weeks
Secondary outcomes (6)
Duration of sleep
Measured by a daily online diary over the total study
Measured: 18 weeks
Evaluation of anxiety
Measured with a questionnaire at each visit
Measured: 18 weeks
Evaluation of perceived stress
Measured with a questionnaire at each visit
Measured: 18 weeks
Evaluation of depression, anxiety and stress
Measured with a questionnaire at each visit
Measured: 18 weeks
Evaluation of quality of life
Measured with a questionnaire at each visit
Measured: 18 weeks
Evaluation of systolic and diastolic blood pressure
Measured at each visit
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start19 Jul 2021
- Primary completion14 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abyss Ingredients
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daacro
- Responsible party
- Sponsor
- Investigators
- Juliane Hellhammer, PhD, Principal investigator, Daacro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983355
- Sponsor's protocol ID
- PEPTIDYSS
- Status last verified
- Aug 2022
- First submitted
- 7 Jul 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38479939
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Marine Based Nutritional Supplement Peptidyss® on Sleep and Anxiety : a Randomized Clinical Trial With a Cross-Over Design in Healthy Adults
- ClinicalTrials.gov ID
- NCT04983355
- Acronym / sponsor ID
- PEPTIDYSS
- Conditions
- Sleep Disorder
- Keywords
- sleep disorder, anxiety, stress, fish hydrolysate, food supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Abyss IngredientsIndustry (pharma, biotech, devices)
- Collaborators
- Daacro
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peptidyss | Experimental | Dietary Supplement: Fish HydrolysateDietary 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) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe 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) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish HydrolysateThe 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 | Peptidyss |
| PlaceboThe 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. | Dietary supplement | Placebo |
Primary outcome
Evaluation of sleep quality
Time frame: 18 weeks
Measured with the Pittsburgh Sleep Quality Index (PSQI) at each visit
6 secondary outcomes
Duration of sleep
Time frame: 18 weeks
Evaluation of anxiety
Time frame: 18 weeks
Evaluation of perceived stress
Time frame: 18 weeks
Evaluation of depression, anxiety and stress
Time frame: 18 weeks
Evaluation of quality of life
Time frame: 18 weeks
Evaluation of systolic and diastolic blood pressure
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 38479939Eckert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliane Hellhammer, PhD principal investigator
Daacro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Hydrolysate in people with Sleep Disorder, run by Abyss Ingredients at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sleep quality (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04983355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.