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Completed

NCT Number: NCT06666244

Carbohydrate Quality, 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.

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Key information

Conditions

Woman

Age range

30 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Yıldırım Beyazıt University

Ankara, 06760, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Women diagnosed with any psychological disorder
  • Cancer patients

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Menopause-Specific Quality of Life Questionnaire (MENQOL)

    Time frame: Basaline

    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.

  2. Menopause Rating Scale (MRS)

    Time frame: Basaline

    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.

  3. Sociodemographic characteristics

    Time frame: Basaline

    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.

  4. Body Mass Index (BMI)

    Time frame: Basaline

    Kilograms per square meter (kg/m2)

  5. Body weight

    Time frame: Basaline

    Body weight in kg

  6. Height

    Time frame: Basaline

    Height in cm

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

Evaluation of the Effect of Carbohydrate Quality on Quality of Life and Menopausal Symptoms in Postmenopausal Women

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 30, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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