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

Official title

A Prospective, Randomized, Double Blind, Placebo Controlled Study To Evaluate The Effects Of Ashwagandha (Withania Somnifera,Ws) Root Plus Leaf Aqueous Extract On Quality Of Sleep In Subjects With Non-Restorative

Overview

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.

Interventions

• Dietary supplement Botanical Extract, 125mg
  Two capsules per day (125 mg/day) before sleep, with or without food, for 8 weeks.
• Dietary supplement Botanical Extract, 250mg
  Two capsules per day (250 mg/day) before sleep, with or without food, for 8 weeks.
• Dietary supplement Botanical Extract, 500mg
  Two capsules per day (500 mg/day) before sleep, with or without food, for 8 weeks
• Dietary supplement Pacebo
  Two capsules per day before sleep, with or without food, for 8 weeks.

Primary outcome measures

• Sleep restorative quality [Time frame: 8 weeks]

Secondary outcome measures (9)

• Sleep Quality [Time frame: 8 weeks]
• Attention-Rapid Visual Information Processing (RVIP) [Time frame: 8 weeks]
• Attention-Sustained Attention to Response Task (SART). [Time frame: 8 weeks]
• Cognition [Time frame: 8 weeks]
• Stress [Time frame: 8 weeks]
• Sleep parameters-Total Sleep Time (TST) [Time frame: 24-hour wear time for 8 weeks]
• Sleep Parameters- Wake After Sleep Onset (WASO) [Time frame: 24-hour wear time for 8 weeks]
• Sleep Parameters- Sleep Onset Latency (SOL) [Time frame: 24-hour wear time for 8 weeks.]
• Sleep Parameters- Sleep Efficiency (SE) [Time frame: 24-hour wear time for 8 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Travel across three time zones in the two months prior to screening or plans to travel across time zones during intervention.
• Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:

• Diagnosed gastrointestinal disease.
• Respiratory disorders
• Seizure disorders
• Type 1 or 2 diabetes mellitus
• Thyroid disorders
• Uncontrolled hypertension
• Cardiovascular disease
• Immunocompromised health conditions
• Current or recent (in the 12 weeks prior to screening) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:

• Barbiturates, anticonvulsants, benzodiazepines, neuroleptics
• Hypnotics
• Melatonin
• Current or recent (in the 4 weeks prior to screening) use of prohibited nutritional or non-nutritional supplements, including:

• Herbal sleep aid supplements (St. John's Wort, Ginkgo-biloba, kava kava)
• Ashwagandha
• Caffeine supplements
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
• Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

Ireland · 1 center

• Atlantia Food Clinical Trials Ltd. — Cork

Identifiers

NCT: NCT07085819 · S24-1511769

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗