Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia

NCT06299488 | Completed DMC

• 1 other identifier: PS03
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Lay Summary: This study is about the effect of using a unique formula called Sip2Sleep®, a product currently available on the market which is a combination of montmorency tart cherry extract and Venetron® (Apocynum venetum leaf extract) on sleep. The purpose of this study is to evaluate the effects of taking this combination product on various aspects of sleep. This study is being conducted by People Science, and is sponsored by Lakshmi Nutraceuticals, LLC. The information we gather will help inform how people may use Sip2Sleep® to affect the quality of sleep. Participants in this study will complete a number of surveys about their difficulties falling asleep and staying asleep (insomnia), their energy level during the day and health status regarding their quality of sleep. There are no major risks associated with this study.

Conditions

Insomnia

Keywords

Sleep; Herbal; Sleep Aid

Outcome Measures

Primary Outcomes (1)

• Subjective Sleep Quality

  Change in average sleep quality score by 1 point as measured by daily 10-point visual analogue rating scale (VAS) from baseline and 1 week of no product use

  14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.

Secondary Outcomes (3)

• Insomnia Sleep Index

  14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.

• Generalized Anxiety Disorder-7 (GAD-7)

  14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.

• Subjective Alertness

  14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.

Other Outcomes (3)

• Exploratory: Sleep Duration

  14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.

• Exploratory: Sleep Latency

  14 days of no intervention versus 14 days of intervention use in a 28 day period, consisting of 1 Week on, 1 week off, 1 week on, 1 week off. Entire study completion for all participants within 1 year.

• Participant Satisfaction

  End of study survey, after completing the 28 study days

Study Arms (2)

Intervention: Montmorency Cherry + Apocynum Venetum

EXPERIMENTAL

Sip2Sleep® is a proprietary formula of Montmorency tart cherry extract and Venetron®, a purified, powdered extract derived from Apocynum Venetum. Recommended dose is ¼ teaspoon which contains 553 mg (1:5 fruit extract) of Montmorency tart cherry and 25mg of Venetron® leaf extract. The compound was prepared as an oral dropper, consumed alone or in water 30-60 minutes prior to bedtime. The study was conducted over a period of four weeks, consisting of two weeks without intervention and two weeks with intervention as follows: (1 week off (baseline) - 1 week on - 1 week off - 1 week on) for each participant

Other: Sip2Sleep: Montmorency Cherry and Apocynum Venetum

No intervention: Typical Sleep Routine

NO INTERVENTION

The study was conducted over a period of four weeks, consisting of two weeks without intervention and two weeks with intervention (ABAB) as follows: (1 week off (baseline) - 1 week on - 1 week off - 1 week on) for each participant. Participants did not consume any intervention or placebo during this time.

Interventions

Sip2Sleep: Montmorency Cherry and Apocynum Venetum OTHER

See arm description

Intervention: Montmorency Cherry + Apocynum Venetum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Has self-reported sleep disturbance
• Insomnia Severity Index (ISI) score of \> 15 at screening
• Interested in understanding more about the quality of their sleep and chose to use the Sip2Sleep product for sleep
• Willingness to do a minimum of 1 week wash out of current OTC or other products for sleep (e.g. melatonin, anticholinergics)
• Willingness to do a minimum of 1 week wash out of any cannabis products
• Able to receive shipment of the product at an address within the United States If taking prescription hypnotics (e.g. zolpidem, zaleplon, benzodiazepines) or other class of medication for sleep, must be on a stable dose for at least 4 weeks.
• Able to read and understand English
• Able to use a personal smartphone
• Has and is able to use a personal health tracking wearable device (e.g., Apple Watch, Fitbit Smartwatch, Oura Ring, etc.)
• Able to understand and provide informed consent
• Able to complete study assessments over 5 weeks

You may not qualify if:

• Research participants who have no computer, smartphone, and internet access and/or do not use a computer or smartphone
• The following concomitant therapies are excluded:
• Participants taking daily prescription medication for sleep (for example, prescription hypnotics like zolpidem, zaleplon, benzodiazepines) not on a stable dose for at least 4 weeks
• Participants receiving Cognitive Behavioral Therapy for Insomnia (CBTi)
• Participants receiving any investigational therapies or treatments
• Other Illnesses or Conditions: Participants who have the following co-morbidities are excluded:
• Confirmed diagnoses of the following sleep disorders: Narcolepsy, Restless Leg Syndrome, Circadian Rhythm Disorders
• Confirmed diagnosis of Sleep Apnea that is untreated or not well controlled
• Current or prior psychotic disorder
• Current or prior Substance Abuse Disorder
• Current or prior cardiac dysrhythmias (for example, atrial fibrillation, supraventricular tachycardia)
• Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding
• Allergies or adverse reactions (for example, anxiety) to Montmorency tart cherry extract and/or Venetron®

Sponsors & Collaborators

• Lakshmi Nutraceuticals LLC: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science Inc.

West Hollywood, California, 90069, United States

Location

Related Publications (6)

• Foley L. Sleep Foundation: Insomnia.

  BACKGROUND

• Losso JN, Finley JW, Karki N, Liu AG, Prudente A, Tipton R, Yu Y, Greenway FL. Pilot Study of the Tart Cherry Juice for the Treatment of Insomnia and Investigation of Mechanisms. Am J Ther. 2018 Mar/Apr;25(2):e194-e201. doi: 10.1097/MJT.0000000000000584.

  PMID: 28901958 BACKGROUND

• Pigeon WR, Carr M, Gorman C, Perlis ML. Effects of a tart cherry juice beverage on the sleep of older adults with insomnia: a pilot study. J Med Food. 2010 Jun;13(3):579-83. doi: 10.1089/jmf.2009.0096.

  PMID: 20438325 BACKGROUND

• Grundmann O, Nakajima J, Seo S, Butterweck V. Anti-anxiety effects of Apocynum venetum L. in the elevated plus maze test. J Ethnopharmacol. 2007 Apr 4;110(3):406-11. doi: 10.1016/j.jep.2006.09.035. Epub 2006 Oct 13.

  PMID: 17101250 BACKGROUND

• Yang, J. et al. 2009. Safety study of Apocynum venetum extract in healthy adults. Journal of Nutritional Food, no. 12:1-9.

  BACKGROUND

• Vissiennon C, Nieber K, Kelber O, Butterweck V. Route of administration determines the anxiolytic activity of the flavonols kaempferol, quercetin and myricetin--are they prodrugs? J Nutr Biochem. 2012 Jul;23(7):733-40. doi: 10.1016/j.jnutbio.2011.03.017. Epub 2011 Aug 12.

  PMID: 21840194 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Noah Craft, MD/PhD

  People Science, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This study is not blinded. Participants consume the intervention on alternating weeks. All participants receive the intervention
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will complete a 5-week study consisting of screening assessments, baseline scales and surveys, objective digital measure, 2 weeks of product use (1 week on - 1 week off - 1 week on), scales and surveys, and end of study assessments and surveys. This is a remote observational study that will use the People Science app-based data collection platform Consumer Health Learning and Organizing Ecosystem (CHLOE) for study participants to report their assessments and collect objective sleep data from personal wearable devices. Participants will receive the study product during the baseline period. Demographic and medical history data will be collected for the study.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 7, 2024
• Study Start: April 5, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)