Sleep Promoting Properties of a Botanical Extract in a Population Complaining From Non-Restorative Sleep (NRS)

NCT07085819 | Recruiting

• 1 other identifier: S24-1511769
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effect of the Botanical Extract in improving sleep symptoms of nonrestorative sleep (NRS) in healthy adults. The main question it aims to answer is

• Does the Botanical Extract improve sleep quality and reduce symptoms of nonrestorative sleep (NRS)? Researchers will compare the Botanical Extract to a placebo to see if it works. Participants will:
• Take one of 3 doses of the Botanical Extract (125 mg/day, 250mg/day ,500mg/day) or a placebo every day for 8 weeks.
• Visit the clinic four times for checkups and tests and receive three follow-up phone calls.

Conditions

Non Restorative Sleep; Sleep Disorder (Disorder)

Keywords

Sleep quality; Attention; Focus; Actigraph

Outcome Measures

Primary Outcomes (1)

• Sleep restorative quality

  To evaluate the impact of 8 weeks daily supplementation of the Botanical Extract on Non-Restorative Sleep (NRS) as assessed by Restorative Sleep Questionnaire (RSQ-W) score compared to placebo. The total score range from 0-100 with higher scores indicating better restorative sleep.

  8 weeks

Secondary Outcomes (9)

• Sleep Quality

  8 weeks

• Attention-Rapid Visual Information Processing (RVIP)

  8 weeks

• Attention-Sustained Attention to Response Task (SART).

  8 weeks

• Cognition

  8 weeks

• Stress

  8 weeks

Study Arms (4)

Botanical Extract 125

EXPERIMENTAL

125 mg

Dietary Supplement: Botanical Extract, 125mg

Botanical Extract 250

EXPERIMENTAL

250 mg

Dietary Supplement: Botanical Extract, 250mg

Botanical Extract 500

EXPERIMENTAL

500 mg

Dietary Supplement: Botanical Extract, 500mg

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Pacebo

Interventions

Botanical Extract, 125mg DIETARY_SUPPLEMENT

Two capsules per day (125 mg/day) before sleep, with or without food, for 8 weeks.

Botanical Extract 125

Botanical Extract, 250mg DIETARY_SUPPLEMENT

Two capsules per day (250 mg/day) before sleep, with or without food, for 8 weeks.

Botanical Extract 250

Botanical Extract, 500mg DIETARY_SUPPLEMENT

Two capsules per day (500 mg/day) before sleep, with or without food, for 8 weeks

Botanical Extract 500

Pacebo DIETARY_SUPPLEMENT

Two capsules per day before sleep, with or without food, for 8 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to give written informed consent.
• Be between 18 and 65 years, inclusive.
• Self-reported unrefreshing sleep despite sufficient sleep duration for at least three nights a week over a one-month period.
• Have a RSQ-W total score of ≤50 at screening.
• TSH values between 0.27 - 4.20 miU/L
• Is in general good health, as determined by the investigator.
• Willing to consume the Study Product daily for the duration of the study.

You may not qualify if:

• Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
• Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
• Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
• Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
• Sexual partner(s) is/are exclusively female.
• Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
• Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
• Has a score ≥10 on Patient Health Questionnaire 8 item (PHQ-8)
• Has a score ≥10 on Athens Insomnia Scale (AIS)
• Participants at a high risk of sleep apnoea as determined by Berlin questionnaire/Score \>5 for sleep apnoea.
• High caffeine intake, \>400mg/day
• Has a history of drug and/or alcohol abuse at the time of enrolment.
• Has food allergies or other issues with foods that would preclude intake of the Study Products.
• Is an active smoker or user of nicotine products, or with a history of cigarettes smoking, tobacco or nicotine product use in the last 6 months.
• Has undertaken shift work within the last three months or plans to undertake shift work during the study.

Sponsors & Collaborators

• Kerry Group P.L.C: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials Ltd.

Cork, T23 R50R, Ireland

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Interventions

PACEBO protocol

Condition Hierarchy (Ancestors)

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

Study Officials

• Timothy Dinan

  Atlantia Clinical Trials LTD.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Blanco, PHD

CONTACT

+34 913 80 29 73; ruth.blanco@kerry.com

Study Design

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

Model Details: Participants will be randomly assigned in a 1:1:1:1 ratio to receive either a dose of a Botanical Extract or a placebo. Study products will be dispensed by the site according to the randomization scheme during the study visits.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 25, 2025
• Study Start: July 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)