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

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

Study Overview

• Status: Completed
• Conditions: Primary Insomnia
• Intervention / Treatment: Behavioral: Banana arm; Behavioral: Milk arm; Behavioral: No intervention

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Selcuk University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eating banana for 6 weeks before bedtime; 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; 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.
Experimental: drinking milk for 6 weeks before bedtime; Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime.	Behavioral: 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.
Experimental: Control; Not making any changes in diet	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Muteber Gizem KESER, PhD,Lecturer, KTO Karatay University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: diet; BDNF; food; Appetite
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 0001 (Cancer Research Institute)

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