Primary InsomniadietNCT05420090
The Effects of Milk and Banana as a Night Meal to Primary Insomnia on Sleep Quality, BDNF and Appetite Mechanism
A study testing Banana arm and Milk arm in people with Primary Insomnia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study to determine the impact of banana and milk on sleep and appetite Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Banana arm and Milk arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Jun 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Applying to the Sleep Polyclinic,
- 18-45 years old,
- Body Mass Index (BMI) between 18.5-25 kg/m2,
- Male and female patients diagnosed with primary sleep disorder for the first time
Who cannot join
- Individuals with any psychiatric illness,
- Those who use cigarettes, alcohol, drugs or sedative drugs,
- Individuals with any chronic disease (diabetes, etc.),
- Pregnant and/or lactating
- Individuals with lactose intolerance,
- athletes,
- Individuals who are allergic to bananas
- Individuals with lactose intolerance or milk intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Milk and Banana Given as a Night Meal to Individuals Diagnosed With Sleep Disorders on Sleep Quality, BDNF and Appetite Mechanism
The aim of this study to determine the impact of banana and milk on sleep and appetite
Read the detailed description
Sleep is one of the main components of the continuity of circadian rhythm. It restores energy and enhancement, memory. Sleep disturbances and short sleep duration are important risk factors for many diseases. Nutrition is one of the main determinants of health status in many diseases related to inflammation. Especially the night meal, known as the foods consumed before bedtime, has a strong effect on sleep. Although there are methodological differences, most studies show that unhealthy eating habits are associated with short sleep duration. It is thought that consuming foods with high tryptophan and melatonin content can reduce sleep problems. This study will give a chance to observe the effects of nutrients on sleep and appetite mechanisms.
- Conditions
- Primary Insomnia
- Being tested
- Banana arm, Milk arm, No intervention
- Keywords
- diet, food, BDNF, Appetite
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banana armBehavioural
Venous blood samples will be taken from the participants in 3 groups before starting the study. Pittsburgh Sleep Quality Index will be applied.Food consumption frequency and food-based follow-up will be carried out.Participants will consume 1 portion of banana (gross 80-85 g) given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. The frequency of food consumption will be taken from the participants each week.
Milk armBehavioural
Venous blood samples will be taken from the participants in 3 groups before starting the study. Pittsburgh Sleep Quality Index will be applied. Food consumption frequency and food-based follow-up will be carried out. Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. The frequency of food consumption will be taken from the participants each week.
No interventionBehavioural
Venous blood samples will be taken from the participants in 3 groups before starting the study. Pittsburgh Sleep Quality Index will be applied. The frequency of food consumption will be taken from the participants each week.Participants are expected not to make any changes in their diet. As in other groups, the frequency of food consumption will be taken from the participants every week in this group. In order to observe the possible changes in the experimental arms, the individuals in the control arm will be asked not to consume bananas and whole milk after 16:00 and they will be informed about this.
| Study group | Role | What they receive |
|---|---|---|
| eating banana for 6 weeks before bedtime | Experimental | Participants will consume 1 portion of banana (gross 80-85 g) given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. Receives: Behavioral: Banana arm |
| drinking milk for 6 weeks before bedtime | Experimental | Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. Receives: Behavioral: Milk arm |
| Control | Experimental | Not making any changes in diet Receives: Behavioral: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline
Change from baseline PSQI at 6 weeks
Measured: at baseline, 6. week
Level of Brain Derived Neurotrophic Factor (pg/ml)
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done (ng/ml)
Measured: at baseline, 6. week
Level of Leptin (mg/dl)
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done (ng/ml)
Measured: at baseline, 6. week
Level of Ghrelin (mg/dl)
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done (ng/ml))
Measured: at baseline and 6. week
Evaluate stages of sleep and the oxygen level in blood
Polymsomnography is used for the diagnosis and treatment plan of sleep disorder and sleep architecture
Measured: at baseline and 6. week
Secondary outcomes (1)
Nutrient intake (g/day)
assessed by a food frequency record as g/day
Measured: 6 consecutive weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jun 2022
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1\. Experimental: Banana arm Experimental: Milk arm Control arm
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muteber Gizem KESER, PhD,Lecturer, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420090
- Sponsor's protocol ID
- 0001
- Acronym
- diet
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Milk and Banana Given as a Night Meal to Individuals Diagnosed With Sleep Disorders on Sleep Quality, BDNF and Appetite Mechanism
- ClinicalTrials.gov ID
- NCT05420090
- Acronym / sponsor ID
- diet / 0001
- Conditions
- Primary Insomnia
- Keywords
- diet, food, BDNF, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Jun 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.
The aim of this study to determine the impact of banana and milk on sleep and appetite
Detailed description
Sleep is one of the main components of the continuity of circadian rhythm. It restores energy and enhancement, memory. Sleep disturbances and short sleep duration are important risk factors for many diseases. Nutrition is one of the main determinants of health status in many diseases related to inflammation. Especially the night meal, known as the foods consumed before bedtime, has a strong effect on sleep. Although there are methodological differences, most studies show that unhealthy eating habits are associated with short sleep duration. It is thought that consuming foods with high tryptophan and melatonin content can reduce sleep problems. This study will give a chance to observe the effects of nutrients on sleep and appetite mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 1. Experimental: Banana arm Experimental: Milk arm Control arm
| Arm | Type | Receives |
|---|---|---|
| eating banana for 6 weeks before bedtime | Experimental | Behavioral: Banana armParticipants will consume 1 portion of banana (gross 80-85 g) given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. |
| drinking milk for 6 weeks before bedtime | Experimental | Behavioral: Milk armParticipants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. |
| Control | Experimental | Behavioral: No interventionNot making any changes in diet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Applying to the Sleep Polyclinic,
- 18-45 years old,
- Body Mass Index (BMI) between 18.5-25 kg/m2,
- Male and female patients diagnosed with primary sleep disorder for the first time
Key exclusion criteria (8 listed)
- Individuals with any psychiatric illness,
- Those who use cigarettes, alcohol, drugs or sedative drugs,
- Individuals with any chronic disease (diabetes, etc.),
- Pregnant and/or lactating
- Individuals with lactose intolerance,
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 |
|---|---|---|
| Banana armVenous blood samples will be taken from the participants in 3 groups before starting the study. Pittsburgh Sleep Quality Index will be applied.Food consumption frequency and food-based follow-up will be carried out.Participants will consume 1 portion of banana (gross 80-85 g) given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. The frequency of food consumption will be taken from the participants each week. | Behavioural | eating banana for 6 weeks before bedtime |
| Milk armVenous blood samples will be taken from the participants in 3 groups before starting the study. Pittsburgh Sleep Quality Index will be applied. Food consumption frequency and food-based follow-up will be carried out. Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. The frequency of food consumption will be taken from the participants each week. | Behavioural | drinking milk for 6 weeks before bedtime |
| No interventionVenous blood samples will be taken from the participants in 3 groups before starting the study. Pittsburgh Sleep Quality Index will be applied. The frequency of food consumption will be taken from the participants each week.Participants are expected not to make any changes in their diet. As in other groups, the frequency of food consumption will be taken from the participants every week in this group. In order to observe the possible changes in the experimental arms, the individuals in the control arm will be asked not to consume bananas and whole milk after 16:00 and they will be informed about this. | Behavioural | Control |
Primary outcome
Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline
Time frame: at baseline, 6. week
Change from baseline PSQI at 6 weeks
Level of Brain Derived Neurotrophic Factor (pg/ml)
Time frame: at baseline, 6. week
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done (ng/ml)
Level of Leptin (mg/dl)
Time frame: at baseline, 6. week
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done (ng/ml)
Level of Ghrelin (mg/dl)
Time frame: at baseline and 6. week
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done (ng/ml))
Evaluate stages of sleep and the oxygen level in blood
Time frame: at baseline and 6. week
Polymsomnography is used for the diagnosis and treatment plan of sleep disorder and sleep architecture
1 secondary outcome
Nutrient intake (g/day)
Time frame: 6 consecutive weeks, 6 weeks
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 20 Jul 2023.
- 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.
Muteber Gizem KESER, PhD,Lecturer principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Banana arm and Milk arm in people with Primary Insomnia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 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 20 Jul 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 Turkey (Türkiye). 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. 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?
Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline (time frame: at baseline, 6. week). The study lists 5 primary outcomes in all. 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 20 Jul 2023.