Poor Quality SleepMilcaNCT06154616
Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)
A study testing Experimental Product: 250, Experimental Product: 250 + TRP and Experimental Product: 600 in people with Poor Quality Sleep, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Randomized, controlled, double-blind intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Quality Sleep
- What is being tested?
- Experimental Product: 250, Experimental Product: 250 + TRP and Experimental Product: 600
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2023to 19 Jan 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults (> 18 years).
- Low sleep quality by Pittsburgh Sleep Quality Questionnaire (PSQI).
- Volunteers able to understand the clinical study and willing to comply with the study procedures and requirements.
Who cannot join
- Subjects with serious or terminal illnesses.
- Subjects with known allergy or hypersensitivity to any of the components of the investigational product.
- Participation in another study involving blood draws or dietary intervention.
- Subjects with body mass index above 32 kg/m2.
- Pregnant or lactating women.
- Use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs.
- Organic dementias such as Alzheimer's, Huntington's disease, Parkinson's and senile dementia.
- Inability to understand informed consent (IC).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Efficacy of Different Types of Milk Enriched With Tryptophan and Supplemented With Ashwagandha Extract in Improving Sleep Quality in Subjects With Sleep Problems
Randomized, controlled, double-blind intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep quality.
Read the detailed description
The duration of the study will be 90 days (12 weeks). Each day they will have to consume the product under investigation. The subjects who meet the selection criteria will be randomly distributed in each of the study groups (A, B, C or D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary on sleep quality and concomitant medication.
They will make a total of two visits to the research laboratory and the tests preestablished in the protocol will be performed. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.
- Conditions
- Poor Quality Sleep
- Being tested
- Control Product, Experimental Product: 250, Experimental Product: 250 + TRP, Experimental Product: 600
- Keywords
- Ashwagandha extract, tryptophan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control ProductDietary supplement
Lactose-free skimmed milk
Experimental Product: 250Dietary supplement
Lactose-free skimmed milk enriched with 250 mg aswaghanda
Experimental Product: 250 + TRPDietary supplement
Lactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan
Experimental Product: 600Dietary supplement
Lactose-free skimmed milk enriched with 600 mg aswaghanda
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Subjects will consume 250 ml of milk half an hour before bedtime. Receives: Dietary Supplement: Control Product |
| Ashw 250 | Experimental | Subjects will consume 250 ml of milk half an hour before bedtime. Receives: Dietary Supplement: Experimental Product: 250 |
| Ashw 250 + TRP | Experimental | Subjects will consume 250 ml of milk half an hour before bedtime. Receives: Dietary Supplement: Experimental Product: 250 + TRP |
| Ashw 600 | Experimental | Subjects will consume 250 ml of milk half an hour before bedtime. Receives: Dietary Supplement: Experimental Product: 600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in sleep quality from baseline at 12 weeks.
Visual analog scale from 0 to 10. The higher the value, the more quality.
Measured: The evolution of sleep quality after consumption during 12 weeks will be measured.
Secondary outcomes (8)
Change in Sleep Quality from baseline at 12 weeks
Visual analog scale from 0 to 10. The higher the value, the more quality.
Measured: Sleep quality will be measured with a daily scale, from baseline to 12 weeks.
Sleep quality
Measured by Pittsburgh test
Measured: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Insomnia severity
Measured by Insomnia severity index - ISI test
Measured: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Sleepiness
Measured by Epworth test
Measured: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Matutinity - Verpertinity
Measured by Matutinity - Verpertinity questionnaire
Measured: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Anxiety questionnaire
Test STAI, to measure the level of anxiety of the subjects
Measured: Day 1, at 12 weeks later
Body composition
It is a control variable. Measured by bioimpedance
Measured: The test will be measured at baseline and after 12 weeks of consumption.
Adverse events
It will be evaluated at each of the visits.
Measured: At 12 weeks after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start15 Sep 2023
- Primary completion20 Dec 2023
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Quality 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154616
- Sponsor's protocol ID
- UCAMCFE-00033
- Acronym
- Milca
- Status last verified
- Sep 2023
- First submitted
- 23 Nov 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Efficacy of Different Types of Milk Enriched With Tryptophan and Supplemented With Ashwagandha Extract in Improving Sleep Quality in Subjects With Sleep Problems
- ClinicalTrials.gov ID
- NCT06154616
- Acronym / sponsor ID
- Milca / UCAMCFE-00033
- Conditions
- Poor Quality Sleep
- Keywords
- Ashwagandha extract, tryptophan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 4 Dec 2023 (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.
Randomized, controlled, double-blind intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep quality.
Detailed description
The duration of the study will be 90 days (12 weeks). Each day they will have to consume the product under investigation. The subjects who meet the selection criteria will be randomly distributed in each of the study groups (A, B, C or D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary on sleep quality and concomitant medication.
They will make a total of two visits to the research laboratory and the tests preestablished in the protocol will be performed. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Control ProductSubjects will consume 250 ml of milk half an hour before bedtime. |
| Ashw 250 | Experimental | Dietary Supplement: Experimental Product: 250Subjects will consume 250 ml of milk half an hour before bedtime. |
| Ashw 250 + TRP | Experimental | Dietary Supplement: Experimental Product: 250 + TRPSubjects will consume 250 ml of milk half an hour before bedtime. |
| Ashw 600 | Experimental | Dietary Supplement: Experimental Product: 600Subjects will consume 250 ml of milk half an hour before bedtime. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults (> 18 years).
- Low sleep quality by Pittsburgh Sleep Quality Questionnaire (PSQI).
- Volunteers able to understand the clinical study and willing to comply with the study procedures and requirements.
Key exclusion criteria (8 listed)
- Subjects with serious or terminal illnesses.
- Subjects with known allergy or hypersensitivity to any of the components of the investigational product.
- Participation in another study involving blood draws or dietary intervention.
- Subjects with body mass index above 32 kg/m2.
- Pregnant or lactating women.
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 |
|---|---|---|
| Control ProductLactose-free skimmed milk | Dietary supplement | Control |
| Experimental Product: 250Lactose-free skimmed milk enriched with 250 mg aswaghanda | Dietary supplement | Ashw 250 |
| Experimental Product: 250 + TRPLactose-free skimmed milk enriched with 250 mg aswaghanda and tryptophan | Dietary supplement | Ashw 250 + TRP |
| Experimental Product: 600Lactose-free skimmed milk enriched with 600 mg aswaghanda | Dietary supplement | Ashw 600 |
Primary outcome
Variation in sleep quality from baseline at 12 weeks.
Time frame: The evolution of sleep quality after consumption during 12 weeks will be measured.
Visual analog scale from 0 to 10. The higher the value, the more quality.
8 secondary outcomes
Change in Sleep Quality from baseline at 12 weeks
Time frame: Sleep quality will be measured with a daily scale, from baseline to 12 weeks.
Sleep quality
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Insomnia severity
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Sleepiness
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Matutinity - Verpertinity
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Anxiety questionnaire
Time frame: Day 1, at 12 weeks later
Body composition
Time frame: The test will be measured at baseline and after 12 weeks of consumption.
Adverse events
Time frame: At 12 weeks after consumption
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 16 Feb 2024.
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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 Experimental Product: 250, Experimental Product: 250 + TRP and Experimental Product: 600 in people with Poor Quality Sleep, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 3 inclusion and 8 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 16 Feb 2024. 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 Spain. 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?
Variation in sleep quality from baseline at 12 weeks. (time frame: The evolution of sleep quality after consumption during 12 weeks will be measured.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2024.