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

Primary Insomnia Clinical Trial

— diet  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05420090
• Other study ID #: 0001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study to determine the impact of banana and milk on sleep and appetite

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Banana arm
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 arm
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 intervention
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.

Locations

Country	Name	City	State
Turkey	Selcuk University Medical Faculty	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline	Change from baseline PSQI at 6 weeks	at baseline, 6. week
Primary	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
Primary	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
Primary	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
Primary	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	Nutrient intake (g/day)	assessed by a food frequency record as g/day	6 consecutive weeks, 6 weeks