Health TrialsbyHealthPanel

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

ConditionsNon Restorative SleepSleep Disorder (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKerry Group P.L.C

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Botanical Extract, 125mg

    Dietary supplement

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

  • Botanical Extract, 250mg

    Dietary supplement

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

  • Botanical Extract, 500mg

    Dietary supplement

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

  • Pacebo

    Dietary supplement

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

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Botanical Extract 125Experimental treatment 1 intervention
Group B: Botanical Extract 250Experimental treatment 1 intervention
Group C: Botanical Extract 500Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

Sleep Quality

To evaluate the impact of 8 weeks daily supplementation with the Botanical Extract compared to placebo on Sleep quality as assessed by Pittsburgh Sleep Quality Questionnaire (PSQI). The total score range from 0 to 21 with the higher score indicating worse sleep quality.

Time frame
8 weeks
2

Attention-Rapid Visual Information Processing (RVIP)

To evaluate the impact of 8 weeks of daily supplementation with the Botanical Extract compared to a placebo on attention using the Millisecond Rapid Visual Information Processing (RVIP) task. The following metrics will be collected and evaluated: latency (speed of response) probability of false alarms, and sensitivity

Time frame
8 weeks
3

Attention-Sustained Attention to Response Task (SART).

To evaluate the impact of 8 weeks of daily supplementation with the Botanical Extract compared to a placebo on attention as assessed by the Millisecond Sustained Attention to Response Task (SART). The following metrics will be collected and evaluated: errors of commission, errors of omission, and reaction time.

Time frame
8 weeks
4

Cognition

To evaluate the impact of 8 weeks daily supplementation with the Botanical Extract compared to placebo on cognition as assessed by Cognitive Function: PROMIS - Abilities-Short Form 8a. The form consists of 8 items, each rated on a 5-point scale from "Never" to "Very often" with higher scores indicating better cognitive function

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kerry Group P.L.C

Lead sponsor

Atlantia Food Clinical Trials

Collaborator

Source ClinicalTrials.gov
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