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

NCT05420090 | Completed DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Insomnia

Keywords

diet; food; BDNF; Appetite

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Nutrient intake (g/day)

  6 consecutive weeks, 6 weeks

Study Arms (3)

eating banana for 6 weeks before bedtime

EXPERIMENTAL

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

drinking milk for 6 weeks before bedtime

EXPERIMENTAL

Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime.

Behavioral: Milk arm

Control

EXPERIMENTAL

Not making any changes in diet

Behavioral: No intervention

Interventions

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.

eating banana for 6 weeks before bedtime

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.

drinking milk for 6 weeks before bedtime

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.

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Gender homogenity will be based
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Applying to the Sleep Polyclinic,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Selcuk University Medical Faculty

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Muteber Gizem KESER, PhD,Lecturer

  KTO Karatay University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: ınvestigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1\. Experimental: Banana arm Experimental: Milk arm Control arm

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 15, 2022
• Study Start: June 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)