The Effect of Menstruation on Food Preference and Balance

April 23, 2023 updated by: hazal genc, Istanbul Medipol University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34070
        • Recruiting
        • Hazal GENÇ
        • Contact:
          • HAZAL genç, phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted using qualitative data with a total of 60 women in the 18-45 age group living in Turkey within 3 months following the ethics committee approval.

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Premenstrual period
For the premenstrual period evaluation, the participants' 10 days before menstruation will be taken as a reference.
Menstrual period
For the evaluation of the menstrual period, the first 3 days when symptoms are seen more will be taken as a reference.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
star excursion balance test
Time Frame: one month
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
One Leg Standing Test
Time Frame: one month
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
Food Record
Time Frame: one month
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
General Anxiety Disorder
Time Frame: one month
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
Premenstrual Syndrome Scale
Time Frame: one month
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Three Factor Nutrition Questionnaire
Time Frame: one month
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
Physical Activity Questionnaire
Time Frame: one month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • menstruation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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