The Effects of Milk and Banana as a Night Meal to Primary Insomnia on Sleep Quality, BDNF and Appetite Mechanism (diet)
Primary Purpose
Primary Insomnia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Banana arm
Milk arm
No intervention
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia focused on measuring diet, food, BDNF, Appetite
Eligibility Criteria
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
Sites / Locations
- Selcuk University Medical Faculty
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
eating banana for 6 weeks before bedtime
drinking milk for 6 weeks before bedtime
Control
Arm Description
Participants will consume 1 portion of banana (gross 80-85 g) given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime.
Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime.
Not making any changes in diet
Outcomes
Primary Outcome Measures
Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline
Change from baseline PSQI at 6 weeks
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)
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)
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))
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
Secondary Outcome Measures
Nutrient intake (g/day)
assessed by a food frequency record as g/day
Full Information
NCT ID
NCT05420090
First Posted
June 1, 2022
Last Updated
July 18, 2023
Sponsor
Saglik Bilimleri Universitesi
1. Study Identification
Unique Protocol Identification Number
NCT05420090
Brief Title
The Effects of Milk and Banana as a Night Meal to Primary Insomnia on Sleep Quality, BDNF and Appetite Mechanism
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
diet, food, BDNF, Appetite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1. Experimental: Banana arm Experimental: Milk arm Control arm
Masking
Investigator
Masking Description
ınvestigator
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eating banana for 6 weeks before bedtime
Arm Type
Experimental
Arm Description
Participants will consume 1 portion of banana (gross 80-85 g) given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime.
Arm Title
drinking milk for 6 weeks before bedtime
Arm Type
Experimental
Arm Description
Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime.
Arm Title
Control
Arm Type
Experimental
Arm Description
Not making any changes in diet
Intervention Type
Behavioral
Intervention Name(s)
Banana arm
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Milk arm
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No intervention
Intervention Description
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 Outcome Measure Information:
Title
Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline
Description
Change from baseline PSQI at 6 weeks
Time Frame
at baseline, 6. week
Title
Level of Brain Derived Neurotrophic Factor (pg/ml)
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done (ng/ml)
Time Frame
at baseline, 6. week
Title
Level of Leptin (mg/dl)
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done (ng/ml)
Time Frame
at baseline, 6. week
Title
Level of Ghrelin (mg/dl)
Description
Fasting (less than 12 hrs) venous blood samples were collected from all the participants and centrifugation of the specimen was done (ng/ml))
Time Frame
at baseline and 6. week
Title
Evaluate stages of sleep and the oxygen level in blood
Description
Polymsomnography is used for the diagnosis and treatment plan of sleep disorder and sleep architecture
Time Frame
at baseline and 6. week
Secondary Outcome Measure Information:
Title
Nutrient intake (g/day)
Description
assessed by a food frequency record as g/day
Time Frame
6 consecutive weeks, 6 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Gender homogenity will be based
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muteber Gizem KESER, PhD,Lecturer
Organizational Affiliation
KTO Karatay University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University Medical Faculty
City
Konya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Milk and Banana as a Night Meal to Primary Insomnia on Sleep Quality, BDNF and Appetite Mechanism
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