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

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Recruiting
CT.gov ID
NCT05420090
Collaborator
(none)
30
1
3
5.5
5.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Banana arm
  • Behavioral: Milk arm
  • Behavioral: No intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1. Experimental: Banana arm Experimental: Milk arm Control armExperimental: Banana arm Experimental: Milk arm Control arm
Masking:
Single (Investigator)
Masking Description:
ınvestigator
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline [at baseline, 6. week]

    Change from baseline PSQI at 6 weeks

  2. 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)

  3. 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)

  4. 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))

  5. 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

Secondary Outcome Measures

  1. Nutrient intake (g/day) [6 consecutive weeks, 6 weeks]

    assessed by a food frequency record as g/day

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Selcuk University Medical Faculty Konya Turkey

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Muteber Gizem KESER, PhD,Lecturer, KTO Karatay University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT05420090
Other Study ID Numbers:
  • 0001
First Posted:
Jun 15, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Saglik Bilimleri Universitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022