Novel Formulation for Sleep Among People With Poor Sleep Quality

Quality of Life Clinical Trial

Official title:

Effect of a Novel Formulation on Sleep Parameters Among People With Poor Sleep Quality: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05609890
• Other study ID #: PAC2422037
• Status: Completed
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: University of Los Andes, Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleep disorders are highly prevalent all around the world and have a strong negative impact on quality of life (QoL). In Colombia, up to 60% of adults report any sleep disturbance and more than 45% have required medical assistance for this. There is abundant anecdotal and scientific evidence supporting the efficacy and safety of several plant extracts on sleep quality. In this context, the development of safe and effective natural products may have a positive impact on sleep and general QoL.

Description:

It is estimated that up to 90% of people will have a sleep concern over their adult life. According to a worldwide survey, one out of two people report unsatisfactory sleep. In Colombia, a Latin American country, more than 60% of adults report sleep concerns. For a long time, positive effects on sleep of plant extracts have been described, and more recently their mechanisms of action and safety have been largely elucidated. This study aims to assess the efficacy and safety of a supplement formulation based on natural products (Saffron, Tea extract, Lemon Balm and Valerian) on objective and subjective sleep parameters.

This is a randomized, doble-blind, placebo controlled clinical trial. The primary outcome is sleep efficiency. A sample size of 60 participants is needed for having a power of 95%, a one type error of 5% and a minimal difference of at least 2.8% between groups in the primary outcome. As we estimate a loss to follow-up of 10%, 66 participants will be enrolled. The main inclusion criteria will be having a poor sleep quality demonstrated as having a Pittsburgh Sleep Quality Index (PSQI) equal to or greater than five. In a random allocation design, one group of participants will receive the active intervention and the other one will receive a placebo with similar organoleptic features. The study will be executed in three main phases: First, a run-in phase where eligible participants will receive the active intervention during one week, and only those with adherence 85% or greater continue to the next phase. Second, a wash-out phase in which participants will not receive any intervention but actigraphic data will be collected. Finally, in the third (intervention) phase participants will be randomized following a minimization algorithm to the active or placebo group, to be taken for six weeks. Subjective and objective sleep variables will be measured at the beginning and the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 31, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >=18, male or female.

• PSQI >=5

• Provision of informed consent

• Adherence >= 85%

Exclusion Criteria:

• Medical history of a specific sleep disorder according to the DSM-5

• Taking any specific pharmacologic treatment to improve sleep or planning to take it in the next two months

• Medical history of generalized anxiety disorder, depression or other serious psychiatric / neurological disease

• Uncontrolled hypothyroidism

• Medical history of deficit or excess of corticosteroids (Cushing syndrome, Addison syndrome, chronic steroid use)

• Alcohol intake (more than two standard drinks/day, on average)

• Caffeine intake more than 400 mg per day, on average

• Frequent sleep deprivation over the last two months

• Women with desire to become pregnant

Related Conditions & MeSH terms

• Insomnia
• Poor Quality Sleep
• Quality of Life
• Sleep
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Dietary Supplement:
• Supplement
Supplement: a mixture of saffron, tea extract, lemon balm and valerian. Dose: The participant will take one sachet every day, one hour before going to bed, for six weeks.

Other:
• Placebo
Placebo sachet Dose: The participant will take one sachet everyday, one hour before going to bed, for six weeks.

Locations

Country	Name	City	State
Colombia	Universidad de los Andes, School of Medicine	Bogotá	Bogota

Sponsors (2)

Lead Sponsor	Collaborator
Carlos O Mendivil	Team Foods Colombia S.A.

Country where clinical trial is conducted

Colombia, 

References & Publications (16)

Aggarwal S, Loomba RS, Arora RR, Molnar J. Associations between sleep duration and prevalence of cardiovascular events. Clin Cardiol. 2013 Nov;36(11):671-6. doi: 10.1002/clc.22160. Epub 2013 Oct 1. — View Citation

Chattu VK, Manzar MD, Kumary S, Burman D, Spence DW, Pandi-Perumal SR. The Global Problem of Insufficient Sleep and Its Serious Public Health Implications. Healthcare (Basel). 2018 Dec 20;7(1):1. doi: 10.3390/healthcare7010001. — View Citation

Choi Y, Choi JW. Association of sleep disturbance with risk of cardiovascular disease and all-cause mortality in patients with new-onset type 2 diabetes: data from the Korean NHIS-HEALS. Cardiovasc Diabetol. 2020 May 13;19(1):61. doi: 10.1186/s12933-020-01032-5. — View Citation

Hargens TA, Kaleth AS, Edwards ES, Butner KL. Association between sleep disorders, obesity, and exercise: a review. Nat Sci Sleep. 2013 Mar 1;5:27-35. doi: 10.2147/NSS.S34838. Print 2013. — View Citation

Knutson KL. Does inadequate sleep play a role in vulnerability to obesity? Am J Hum Biol. 2012 May-Jun;24(3):361-71. doi: 10.1002/ajhb.22219. Epub 2012 Jan 24. — View Citation

Lin CL, Chien WC, Chung CH, Wu FL. Risk of type 2 diabetes in patients with insomnia: A population-based historical cohort study. Diabetes Metab Res Rev. 2018 Jan;34(1). doi: 10.1002/dmrr.2930. Epub 2017 Oct 4. — View Citation

McCoy JG, Strecker RE. The cognitive cost of sleep lost. Neurobiol Learn Mem. 2011 Nov;96(4):564-82. doi: 10.1016/j.nlm.2011.07.004. Epub 2011 Aug 22. — View Citation

Medic G, Wille M, Hemels ME. Short- and long-term health consequences of sleep disruption. Nat Sci Sleep. 2017 May 19;9:151-161. doi: 10.2147/NSS.S134864. eCollection 2017. — View Citation

Meerlo P, Sgoifo A, Suchecki D. Restricted and disrupted sleep: effects on autonomic function, neuroendocrine stress systems and stress responsivity. Sleep Med Rev. 2008 Jun;12(3):197-210. doi: 10.1016/j.smrv.2007.07.007. Epub 2008 Jan 25. — View Citation

Meng L, Zheng Y, Hui R. The relationship of sleep duration and insomnia to risk of hypertension incidence: a meta-analysis of prospective cohort studies. Hypertens Res. 2013 Nov;36(11):985-95. doi: 10.1038/hr.2013.70. Epub 2013 Sep 5. — View Citation

Mogavero MP, DelRosso LM, Fanfulla F, Bruni O, Ferri R. Sleep disorders and cancer: State of the art and future perspectives. Sleep Med Rev. 2021 Apr;56:101409. doi: 10.1016/j.smrv.2020.101409. Epub 2020 Nov 28. — View Citation

Ong JL, Lau T, Massar SAA, Chong ZT, Ng BKL, Koek D, Zhao W, Yeo BTT, Cheong K, Chee MWL. COVID-19-related mobility reduction: heterogenous effects on sleep and physical activity rhythms. Sleep. 2021 Feb 12;44(2):zsaa179. doi: 10.1093/sleep/zsaa179. — View Citation

Pan XL, Nie L, Zhao SY, Zhang XB, Zhang S, Su ZF. The Association Between Insomnia and Atherosclerosis: A Brief Report. Nat Sci Sleep. 2022 Mar 15;14:443-448. doi: 10.2147/NSS.S336318. eCollection 2022. — View Citation

Rod NH, Vahtera J, Westerlund H, Kivimaki M, Zins M, Goldberg M, Lange T. Sleep disturbances and cause-specific mortality: Results from the GAZEL cohort study. Am J Epidemiol. 2011 Feb 1;173(3):300-9. doi: 10.1093/aje/kwq371. Epub 2010 Dec 30. — View Citation

Ruiz AJ, Sepulveda MA, Martinez PH, Munoz MC, Mendoza LO, Centanaro OP, Carrasco LF, Garcia JC. Prevalence of sleep complaints in Colombia at different altitudes. Sleep Sci. 2016 Apr-Jun;9(2):100-5. doi: 10.1016/j.slsci.2016.05.008. Epub 2016 Jun 4. — View Citation

Schipper SBJ, Van Veen MM, Elders PJM, van Straten A, Van Der Werf YD, Knutson KL, Rutters F. Sleep disorders in people with type 2 diabetes and associated health outcomes: a review of the literature. Diabetologia. 2021 Nov;64(11):2367-2377. doi: 10.1007/s00125-021-05541-0. Epub 2021 Aug 16. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency	The change (Week 6 - baseline) in Sleep Efficiency (the ratio of total sleep time to time in bed)	Baseline (week 0) - Final (week 6)
Secondary	Pittsburg Sleep Quality Index (PSQI) (0-21) higher scores means worse sleep quality	Change from baseline in the PSQI	Baseline (week 0) - Final (week 6)
Secondary	Short Form-36 Quality of Life score (SF-36) (0-100), higher score means better quality of life	Change in QoL measured by the 36-Item Short Form Survey (SF-36)	Baseline (week 0) - Final (week 6)
Secondary	Morning salivary cortisol	Change in salivary cortisol (as a measurement of response to stress)	Baseline (week 0) - Final (week 6)
Secondary	Blood creatinine	Change in blood creatinine	Baseline (week 0) - Final (week 6)
Secondary	Blood alanine amino transferase	Change in blood alanine amino transferase	Baseline (week 0) - Final (week 6)

External Links

•   Filip I, Tidman M, Saheba N, Bennet H, Wick B, Rouse N, Patriche D, Radfar A. Public health burden of sleep disorders underreported problem. J Public Health 2016;25:243-248.
•   Koninklijke Philips N.V. Wake up call: global sleep satisfaction trends. Philips Global Survey [Internet] 2020 [consultado 2022 junio 28].