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

Not Applicable

Completed

• Conditions: Primary Insomnia
• Interventions: Behavioral: Milk arm; Behavioral: No intervention; Behavioral: Banana arm

• Registration Number: NCT05420090
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

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 Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-15
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drinking milk for 6 weeks before bedtime	Milk arm	Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime.
Control	No intervention	Not making any changes in diet
eating banana for 6 weeks before bedtime	Banana arm	Participants will consume 1 portion of banana (gross 80-85 g) given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime.

Primary Outcome Measures

Name	Time	Method
Level of Leptin (mg/dl)	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)
Evaluate stages of sleep and the oxygen level in blood	at baseline and 6. week	Polymsomnography is used for the diagnosis and treatment plan of sleep disorder and sleep architecture
Level of Brain Derived Neurotrophic Factor (pg/ml)	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)
Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline	at baseline, 6. week	Change from baseline PSQI at 6 weeks
Level of Ghrelin (mg/dl)	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))

Secondary Outcome Measures

Name	Time	Method
Nutrient intake (g/day)	6 consecutive weeks, 6 weeks	assessed by a food frequency record as g/day

Trial Locations

Locations (1)

Selcuk University Medical Faculty; 🇹🇷 Konya, Turkey