WomanNCT06666244
Carbohydrate Quality, Quality of Life, and Menopausal Symptoms in Postmenopausal Women
An observational study of Woman, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women. Data were collected from 604 postmenopausal women using a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Read more about this study
- Who is it for?
- Ages 30 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Woman
- How many people
- 604 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample in Ankara, Turkey
Who may be able to join
- Women who have not menstruated for 12 consecutive months and have no intermenstrual bleeding
- Aged between 30 and 90 years
- Must be willing to volunteer
Who cannot join
- Women diagnosed with any psychological disorder
- Cancer patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, 06760
About this study
Official title: Evaluation of the Effect of Carbohydrate Quality on Quality of Life and Menopausal Symptoms in Postmenopausal Women
This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women. Data were collected from 604 postmenopausal women using a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data, and the results were analyzed with SPSS 24 software.
Read the detailed description
Objective: This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women.
Method: A total of 604 postmenopausal women participated in the study. Participants completed a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data and analyzed based on dietary fiber, glycemic index, solid carbohydrate-to-total carbohydrate ratio, and whole grains-to-total grains ratio. Results were divided into five quartiles, with Q5 representing the highest and Q1 the lowest carbohydrate quality. Data analysis was conducted using SPSS 24 software.
- Conditions
- Woman
- Keywords
- Carbohydrate Quality, Quality of life, Menopausal Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal Women | This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women. Data were collected from 604 postmenopausal women using a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data, and results were analyzed with SPSS 24 software. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating carbohydrate quality
132 food groups obtained from the food consumption frequency questionnaire were analyzed. Daily intake (g/day) was calculated using the BeBiS program with a global database, based on the amount and frequency of food consumed by participants. Glycaemic Index (GI) values were also determined using the BeBiS program, taking into account both the amount and frequency of food consumed. To determine the Carbohydrate Quality Index score, each of the four components (fiber intake, whole grain ratio, Glycaemic Index, and total carbohydrate ratio) was rated from 1 to 5 points. The score for each component was then summed. Q5 indicates the highest and Q1 the lowest carbohydrate quality.
Measured: Basaline
Secondary outcomes (6)
Menopause-Specific Quality of Life Questionnaire (MENQOL)
This scale is used to assess quality of life during menopause. It consists of 29 questions across four subdimensions, with scores ranging from 1 to 8. Higher scores on this scale indicate greater severity of complaints.
Measured: Basaline
Menopause Rating Scale (MRS)
This scale was used to measure the severity and frequency of menopausal symptoms. It includes three subdimensions: psychological, somatic, and urogenital complaints. Each question has five response options (scored from 0 to 4), with a total possible score of 44 and a minimum score of 0. Higher scores indicate a greater negative impact on quality of life and an increase in symptoms.
Measured: Basaline
Sociodemographic characteristics
Sociodemographic characteristics will be assessed using a structured questionnaire developed by the researchers. The questionnaire will include items on age, gender, education level, and income status. Results will be presented as frequencies and percentages for each characteristic.
Measured: Basaline
Body Mass Index (BMI)
Kilograms per square meter (kg/m2)
Measured: Basaline
Body weight
Body weight in kg
Measured: Basaline
Height
Height in cm
Measured: Basaline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Jan 2023
- Primary completion15 Jun 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomanStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Elibol, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666244
- Sponsor's protocol ID
- AYBUELİBOL004
- Status last verified
- Sep 2024
- First submitted
- 23 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Carbohydrate Quality on Quality of Life and Menopausal Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06666244
- Acronym / sponsor ID
- AYBUELİBOL004
- Conditions
- Woman
- Keywords
- Carbohydrate Quality, Quality of life, Menopausal Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women. Data were collected from 604 postmenopausal women using a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data, and the results were analyzed with SPSS 24 software.
Detailed description
Objective: This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women.
Method: A total of 604 postmenopausal women participated in the study. Participants completed a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data and analyzed based on dietary fiber, glycemic index, solid carbohydrate-to-total carbohydrate ratio, and whole grains-to-total grains ratio. Results were divided into five quartiles, with Q5 representing the highest and Q1 the lowest carbohydrate quality. Data analysis was conducted using SPSS 24 software.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal Women | – | –This study aimed to evaluate the effect of carbohydrate quality on quality of life and menopausal symptoms in postmenopausal women. Data were collected from 604 postmenopausal women using a demographic questionnaire, the Menopause-Specific Quality of Life Questionnaire (MENQOL), and the Menopause Rating Scale (MRS). Carbohydrate quality was assessed using food frequency consumption data, and results were analyzed with SPSS 24 software. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample in Ankara, Turkey
Key inclusion criteria (3 listed)
- Women who have not menstruated for 12 consecutive months and have no intermenstrual bleeding
- Aged between 30 and 90 years
- Must be willing to volunteer
Key exclusion criteria (2 listed)
- Women diagnosed with any psychological disorder
- Cancer patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluating carbohydrate quality
Time frame: Basaline
132 food groups obtained from the food consumption frequency questionnaire were analyzed. Daily intake (g/day) was calculated using the BeBiS program with a global database, based on the amount and frequency of food consumed by participants. Glycaemic Index (GI) values were also determined using the BeBiS program, taking into account both the amount and frequency of food consumed. To determine the Carbohydrate Quality Index score, each of the four components (fiber intake, whole grain ratio, Glycaemic Index, and total carbohydrate ratio) was rated from 1 to 5 points. The score for each component was then summed. Q5 indicates the highest and Q1 the lowest carbohydrate quality.
6 secondary outcomes
Menopause-Specific Quality of Life Questionnaire (MENQOL)
Time frame: Basaline
Menopause Rating Scale (MRS)
Time frame: Basaline
Sociodemographic characteristics
Time frame: Basaline
Body Mass Index (BMI)
Time frame: Basaline
Body weight
Time frame: Basaline
Height
Time frame: Basaline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Woman, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating carbohydrate quality (time frame: Basaline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.