The Effects of Milk and Banana as a Night Meal to Primary Insomnia on Sleep Quality, BDNF and Appetite Mechanism

Study Overview
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Brief Summary
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The aim of this study to determine the impact of banana and milk on sleep and appetite

Detailed Description
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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.

Official Title
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The Effects of Milk and Banana Given as a Night Meal to Individuals Diagnosed With Sleep Disorders on Sleep Quality, BDNF and Appetite Mechanism

Conditions
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Primary Insomnia

Intervention / Treatment
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* Behavioral: Banana arm
* Behavioral: Milk arm
* Behavioral: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1. Experimental: Banana arm Experimental: Milk arm Control arm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eating banana for 6 weeks before bedtime<br>Participants will consume 1 portion of banana (gross 80-85 g) given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. | Behavioral: Banana arm<br>* 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.<br>|
| Experimental: drinking milk for 6 weeks before bedtime<br>Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. | Behavioral: Milk arm<br>* 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.<br>|
| Experimental: Control<br>Not making any changes in diet | Behavioral: No intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline | Change from baseline PSQI at 6 weeks | 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) | 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) | 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)) | 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 | at baseline and 6. week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrient intake (g/day) | assessed by a food frequency record as g/day | 6 consecutive weeks, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, food, BDNF, Appetite