Skip to main content
OpenTrials
Completed

NCT Number: NCT05420090

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University Medical Faculty

Konya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Banana arm

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline

    Time frame: at baseline, 6. week

    Change from baseline PSQI at 6 weeks

  2. 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)

  3. 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)

  4. 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))

  5. 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

Secondary outcomes

  1. Nutrient intake (g/day)

    Time frame: 6 consecutive weeks, 6 weeks

    assessed by a food frequency record as g/day

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study 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

Acronym: diet

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2022
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.