NCT05609890

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 25, 2022

Last Update Submit

August 3, 2023

Conditions

SleepSleep DisorderInsomniaQuality of LifePoor Quality Sleep

Keywords

SleepSupplementNutraceuticalHealthQuality of lifeActigraphy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pittsburg Sleep Quality Index (PSQI) (0-21) higher scores means worse sleep quality

    Baseline (week 0) - Final (week 6)

  • Short Form-36 Quality of Life score (SF-36) (0-100), higher score means better quality of life

    Baseline (week 0) - Final (week 6)

  • Morning salivary cortisol

    Baseline (week 0) - Final (week 6)

  • Blood creatinine

    Baseline (week 0) - Final (week 6)

  • Blood alanine amino transferase

    Baseline (week 0) - Final (week 6)

Study Arms (2)

Active intervention

EXPERIMENTAL

A formulation made of natural components. Each sachet contains saffron, tea extract, lemon balm and valerian.

Dietary Supplement: Supplement

Placebo

PLACEBO COMPARATOR

Placebo sachet will contain inert excipient.

Other: Placebo

Interventions

SupplementDIETARY_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.

Active intervention
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>=18, male or female.
  • PSQI \>=5
  • Provision of informed consent
  • Adherence \>= 85%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de los Andes, School of Medicine

Bogotá, Bogota D.C., 110111, Colombia

Location

Related Publications (16)

  • 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.

    PMID: 27656274BACKGROUND

  • 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.

    PMID: 32918076BACKGROUND

  • 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.

    PMID: 28579842BACKGROUND

  • 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.

    PMID: 18222099BACKGROUND

  • 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.

    PMID: 21875679BACKGROUND

  • 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.

    PMID: 24005775BACKGROUND

  • 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.

    PMID: 35313542BACKGROUND

  • 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.

    PMID: 23620691BACKGROUND

  • 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.

    PMID: 22275135BACKGROUND

  • 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.

    PMID: 34401953BACKGROUND

  • 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.

    PMID: 28834008BACKGROUND

  • 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.

    PMID: 24122853BACKGROUND

  • 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.

    PMID: 32404104BACKGROUND

  • 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.

    PMID: 33333427BACKGROUND

  • 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.

    PMID: 21193534BACKGROUND

  • 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.

    PMID: 30577441BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Wake DisordersSleep Initiation and Maintenance Disorders

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomnias

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The participants and the investigator who will provide the intervention and collect the data will be masked about interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 25, 2022

First Posted

November 8, 2022

Study Start

January 15, 2023

Primary Completion

April 26, 2023

Study Completion

July 31, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)