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

Sponsor

Abyss Ingredients (Industry)

Overall Status

Completed

CT.gov ID

NCT04983355

Collaborator

Daacro (Other)

Enrollment

Location

Arms

6.2

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder	Dietary Supplement: Fish Hydrolysate Dietary Supplement: Placebo	N/A

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

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jul 19, 2021

Actual Primary Completion Date :

Jan 14, 2022

Actual Study Completion Date :

Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peptidyss 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 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.
Placebo Comparator: Placebo 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 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.

Arm

Intervention/Treatment

Experimental: Peptidyss

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

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.

Placebo Comparator: Placebo

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

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.

Outcome Measures

Primary Outcome Measures

Evaluation of sleep quality [18 weeks]
Measured with the Pittsburgh Sleep Quality Index (PSQI) at each visit

Secondary Outcome Measures

Duration of sleep [18 weeks]
Measured by a daily online diary over the total study
Evaluation of anxiety [18 weeks]
Measured with a questionnaire at each visit
Evaluation of perceived stress [18 weeks]
Measured with a questionnaire at each visit
Evaluation of depression, anxiety and stress [18 weeks]
Measured with a questionnaire at each visit
Evaluation of quality of life [18 weeks]
Measured with a questionnaire at each visit
Evaluation of systolic and diastolic blood pressure [18 weeks]
Measured at each visit

Other Outcome Measures

Evaluation of salivary cortisol [18 weeks]
Measured the day and evening prior to each visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.