SleepNCT05609890
Novel Formulation for Sleep Among People With Poor Sleep Quality
A study testing Supplement in people with Sleep and Sleep Disorder, run by Carlos O Mendivil at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Disorder, Insomnia
- What is being tested?
- Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteColombia
- Study dates
- 15 Jan 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >=18, male or female.
- PSQI >=5
- Provision of informed consent
- Adherence >= 85%
Who cannot join
- 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)
Show all 9Show fewer
- Caffeine intake more than 400 mg per day, on average
- Frequent sleep deprivation over the last two months
- Women with desire to become pregnant
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Universidad de los Andes, School of Medicine
Bogotá, Bogota D.C., 110111
About this study
Official title: Effect of a Novel Formulation on Sleep Parameters Among People With Poor Sleep Quality: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Sleep, Sleep Disorder, Insomnia, Quality of Life, Poor Quality Sleep
- Being tested
- Supplement, Placebo
- Keywords
- Sleep, Supplement, Nutraceutical, Health, Quality of life, Actigraphy
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
Placebo sachet
Dose: The participant will take one sachet everyday, one hour before going to bed, for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active intervention | Experimental | A formulation made of natural components. Each sachet contains saffron, tea extract, lemon balm and valerian. Receives: Dietary Supplement: Supplement |
| Placebo | Placebo comparator | Placebo sachet will contain inert excipient. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
The change (Week 6 - baseline) in Sleep Efficiency (the ratio of total sleep time to time in bed)
Measured: Baseline (week 0) - Final (week 6)
Secondary outcomes (5)
Pittsburg Sleep Quality Index (PSQI) (0-21) higher scores means worse sleep quality
Change from baseline in the PSQI
Measured: Baseline (week 0) - Final (week 6)
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)
Measured: Baseline (week 0) - Final (week 6)
Morning salivary cortisol
Change in salivary cortisol (as a measurement of response to stress)
Measured: Baseline (week 0) - Final (week 6)
Blood creatinine
Change in blood creatinine
Measured: Baseline (week 0) - Final (week 6)
Blood alanine amino transferase
Change in blood alanine amino transferase
Measured: Baseline (week 0) - Final (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start15 Jan 2023
- Primary completion26 Apr 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carlos O Mendivil
- Sponsor type
- University, hospital or other
- Collaborators
- Team Foods Colombia S.A.
- Responsible party
- Sponsor-investigator, Carlos O Mendivil, University of Los Andes, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609890
- Sponsor's protocol ID
- PAC2422037
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27656274Ong 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.
PubMed 32918076Medic 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.
PubMed 28579842Meerlo 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.
PubMed 18222099McCoy 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.
PubMed 21875679Meng 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.
PubMed 24005775Pan 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.
PubMed 35313542Hargens 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.
PubMed 23620691Knutson 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.
PubMed 22275135Schipper 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.
PubMed 34401953Lin 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.
PubMed 28834008Aggarwal 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.
PubMed 24122853Choi 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.
PubMed 32404104Mogavero 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.
PubMed 33333427Rod 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.
PubMed 21193534
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Formulation on Sleep Parameters Among People With Poor Sleep Quality: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05609890
- Acronym / sponsor ID
- PAC2422037
- Conditions
- Sleep, Sleep Disorder, Insomnia, Quality of Life, Poor Quality Sleep
- Keywords
- Sleep, Supplement, Nutraceutical, Health, Quality of life, Actigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Carlos O MendivilUniversity, hospital or other
- Collaborators
- Team Foods Colombia S.A.
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Dietary Supplement: SupplementA formulation made of natural components. Each sachet contains saffron, tea extract, lemon balm and valerian. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo sachet will contain inert excipient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >=18, male or female.
- PSQI >=5
- Provision of informed consent
- Adherence >= 85%
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupplementSupplement: 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. | Dietary supplement | Active intervention |
| PlaceboPlacebo sachet Dose: The participant will take one sachet everyday, one hour before going to bed, for six weeks. | Other | Placebo |
Primary outcome
Sleep efficiency
Time frame: Baseline (week 0) - Final (week 6)
The change (Week 6 - baseline) in Sleep Efficiency (the ratio of total sleep time to time in bed)
5 secondary outcomes
Pittsburg Sleep Quality Index (PSQI) (0-21) higher scores means worse sleep quality
Time frame: Baseline (week 0) - Final (week 6)
Short Form-36 Quality of Life score (SF-36) (0-100), higher score means better quality of life
Time frame: Baseline (week 0) - Final (week 6)
Morning salivary cortisol
Time frame: Baseline (week 0) - Final (week 6)
Blood creatinine
Time frame: Baseline (week 0) - Final (week 6)
Blood alanine amino transferase
Time frame: Baseline (week 0) - Final (week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Background: PubMed 27656274Ruiz 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.
- Background: PubMed 32918076Ong 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.
- Background: PubMed 28579842Medic 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.
- Background: PubMed 18222099Meerlo 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.
- Background: PubMed 21875679McCoy 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.
- Background: PubMed 24005775Meng 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.
- Background: PubMed 35313542Pan 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.
- Background: PubMed 23620691Hargens 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.
- Background: PubMed 22275135Knutson 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.
- Background: PubMed 34401953Schipper 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.
- Background: PubMed 28834008Lin 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.
- Background: PubMed 24122853Aggarwal 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.
- Koninklijke Philips N.V. Wake up call: global sleep satisfaction trends. Philips Global Survey \[Internet\] 2020 \[consultado 2022 junio 28\].Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Sleep and Sleep Disorder, run by Carlos O Mendivil at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: Baseline (week 0) - Final (week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05609890, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.