Novel Formulation for Sleep Among People With Poor Sleep Quality

August 3, 2023 updated by: Carlos O Mendivil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
    • Bogota
      • Bogotá, Bogota, Colombia, 110111
        • Universidad de los Andes, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active intervention
A formulation made of natural components. Each sachet contains saffron, tea extract, lemon balm and valerian.
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.
Placebo Comparator: Placebo
Placebo sachet will contain inert excipient.
Other: Placebo

Placebo sachet

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (week 0) - Final (week 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburg Sleep Quality Index (PSQI) (0-21) higher scores means worse sleep quality
Time Frame: Baseline (week 0) - Final (week 6)
Change from baseline in the PSQI
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)
Change in QoL measured by the 36-Item Short Form Survey (SF-36)
Baseline (week 0) - Final (week 6)
Morning salivary cortisol
Time Frame: Baseline (week 0) - Final (week 6)
Change in salivary cortisol (as a measurement of response to stress)
Baseline (week 0) - Final (week 6)
Blood creatinine
Time Frame: Baseline (week 0) - Final (week 6)
Change in blood creatinine
Baseline (week 0) - Final (week 6)
Blood alanine amino transferase
Time Frame: Baseline (week 0) - Final (week 6)
Change in blood alanine amino transferase
Baseline (week 0) - Final (week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carlos O Mendivil

Collaborators

Team Foods Colombia S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

April 26, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAC2422037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe