The Effect of Menstruation on Food Preference and Balance

Menstrual Cycle Clinical Trial

Official title:

The Effect of Menstruation on Food Preference and Balance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821439
• Other study ID #: menstruation
• Status: Recruiting
• Start date: April 23, 2023
• Est. completion date: July 21, 2023

Study information

• Verified date: April 2023
• Source: Istanbul Medipol University Hospital
• Contact: HAZAL GENÇ, PhD
• Phone: 05413204291
• Email: hazaloksuz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Menstruation period, which is accepted as the symbol of fertility, and some problems related to this process covers half of a woman's life. During this period, various changes occur in the female body, especially in the endocrine system. These changes in the menstrual cycle can affect women physiologically and psychologically.

Description:

Premenstrual syndrome (PMS) is an important health problem and negatively affects the quality of life of many women around the world. It usually begins 2 years after menarche and is known to worsen with age.It is known that approximately 80%-95% of women experience various degrees of PMS-related complaints. It has been reported that Premenstrual Syndrome can occur with more than 300 symptoms. The symptoms of PMS can be experienced in varying degrees, such as mild, moderate, and severe. The rate of those experiencing severe symptoms in PMS varies between 3-8%. Among the symptoms, psychological symptoms take the most important place. These; symptoms such as irritability, depression, anxiety, restlessness, nervousness, irritability, outbursts of anger and crying spells, feeling of loss of control, difficulty concentrating, laziness, insomnia or hypersomnia. The most common physical symptoms are joint, muscle, headache and abdominal pain, acne, edema, dizziness, libido and appetite changes, gastrointestinal disturbances, bloating, weight gain, breast fullness and tenderness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 21, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria

• Having completed the age of 18,

• Not over 45 years old and not in menopause,

• Not having any diagnosed psychological disease,

• It was determined as women who are healthy and have menstruation every month. Exclusion Criteria

• Individuals who menstruate with medical treatment every month,

• Individuals with lower extremity disability,

Related Conditions & MeSH terms

• Menstrual Cycle

Locations

Country	Name	City	State
Turkey	HAZAL genç	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Souza LB, Martins KA, Cordeiro MM, Rodrigues YS, Rafacho BPM, Bomfim RA. Do Food Intake and Food Cravings Change during the Menstrual Cycle of Young Women? Rev Bras Ginecol Obstet. 2018 Nov;40(11):686-692. doi: 10.1055/s-0038-1675831. Epub 2018 Nov 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	star excursion balance test	On the previously prepared platform; There are 8 linear lines that form a star shape, arranged at an angle of 45 degrees between them. Before the test was administered to the individuals, necessary explanations were made and they were informed about the test. The individual to be tested was positioned to coincide with the very center of this shape. The untested leg was used to maintain the stability of the body in full contact with the ground. The tested leg, on the other hand, was asked to extend maximum in different directions and return to the starting position.	one month
Primary	Food Record	Food records were evaluated in the "Nutrition Determine" program, and each participant received) amounts were calculated. Selections and intakes of nutrients will be evaluated. The Three-Factor Eating Questionnaire-Revised 18 Items (TFEQ-R18) consists of 18 items ona 4-point Likert scale (1 = definitely true, 2 = mostly true, 3 = mostly false, 4 = definitely false).Responses to each of the 18 items are summated into scale scores for cognitive restraint, uncontrolledeating, and emotional eating .igher scores in the respective scales areindicative of greater cognitive restraint, uncontrolled, or emotional eating.	one month
Primary	General Anxiety Disorder	It is a test that evaluates the anxiety disorder of individuals with a short and self-reported way. It questions the emotions and mood changes experienced by individuals in the last 2 weeks. Each question of this test, which consists of 7 questions, has a 4-point Likert option. According to the scores obtained from the scale; 5,10,15 are used as cutoff points for mild, moderate and severe anxiety, respectively. In individuals with a total score of 10 and above, their anxiety should be investigated and confirmed by other methods. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.	one month
Primary	One Leg Standing Test	Before starting the test, the desired position was shown to the individuals and it will be explained in which cases the test will be invalid. This test was planned to be performed on both the right and left legs of the individuals. The desired position is for the untested leg; hip and leg flexed to 90 degrees, arms free, and the tested leg in full extension.	one month
Primary	Premenstrual Syndrome Scale	Before answering the questions, individuals will be asked to think about the 7 days before menstruation. The scale consists of 44 questions in five-point Likert type.The lowest score is 44, and 220 is the highest. If the score (> 132)it will considered a positive Premenstrual Syndrome and as the score gets higher then indicate greater severity of symptoms during Premenstrual Syndrome .	one month
Secondary	Three Factor Nutrition Questionnaire	With this questionnaire, which is used to evaluate the nutritional habits of individuals, our study measures the degree of conscious restriction of eating, the level of uncontrolled eating, and the degree of emotional eating.	one month
Secondary	Physical Activity Questionnaire	Physical activity level will be evaluated with the International Physical Activity .Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level. intensity activities achieving a minimum total physical activity of at least 3000 MET minutes a week. Questionnaire (UFAA). The short form contains a total of 7 questions. Questionnaire; It allows us to obtain information about the time spent walking, during moderate and vigorous activities, and sitting. The measurement of all activities performed is based on the fact that each activity is performed for at least 10 minutes at a time. According to the total physical activity score, the physical activity levels of the participants are defined as "low, medium and high".	one month