Impact of Nutritional Supplementation on Sleep Quality

Pharmavite

Status and phase: Not yet enrolling; Phase 1

Conditions: Sleep Quality; Sleep

Treatments: Dietary Supplement: Sleep Supplements; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06935123

AFCRO-189

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.

Enrollment: 376 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Be able to give written informed consent.
2. Be between 18-65 years of age (inclusive).
3. Insomnia severity Index score ≤14.
4. PROMIS Sleep Disturbance Questionnaire raw score ≥23
5. Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
6. Willing to consume the study product daily for the duration of the study.

Exclusion criteria

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

2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception as determined by the investigator.

3. Has a history of drug and/or alcohol abuse.

4. Hypersensitive to the contents of the study product.

5. Participants with work schedules that result in irregular sleep patterns/ or have night-shift employment.

6. High caffeine intake, >400mg/day.

7. 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. Excluded health conditions include:

   1. Diagnosed Sleep disorders
   2. Major psychiatric diagnosis (e.g., bipolar), as diagnosed by a healthcare professional, including major depressive disorder (e.g., clinical depression)
   3. Immunocompromised health conditions

8. Currently or recently (in the past 4 weeks) taking 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:

   1. Prescribed sleep medications
   2. Prescribed Medications which impact sleep, including but not limited to sedative hypnotics, anxiolytics, and antidepressants.

9. Current or recent (in the past 4 weeks) use of prohibited nutritional and non-nutritional supplements with known or possible sleep effects (e.g. valerian, multivitamins, melatonin)

10. 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.

11. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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376 participants in 5 patient groups, including a placebo group

Sleep Supplement 1

Active Comparator group

Description:

Participants served Sleep Supplement 1

Treatment:

Dietary Supplement: Sleep Supplements

Sleep Supplement 2

Active Comparator group

Description:

Participants served Sleep Supplement 2

Treatment:

Dietary Supplement: Sleep Supplements

Sleep Supplement 3

Active Comparator group

Description:

Participants served Sleep Supplement 3

Treatment:

Dietary Supplement: Sleep Supplements

Sleep Supplement 4

Active Comparator group

Description:

Participants served Sleep Supplement 4

Treatment:

Dietary Supplement: Sleep Supplements

Placebo

Placebo Comparator group

Description:

Participants served placebo

Treatment:

Other: Placebo