NCT06666244

Brief 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). Carbohydrate quality was assessed using food frequency consumption data, and the results were analyzed with SPSS 24 software.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
604

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
Last Updated

October 30, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

October 23, 2024

Last Update Submit

October 29, 2024

Conditions

Keywords

Carbohydrate QualityQuality of lifeMenopausal Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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.

    Basaline

Secondary Outcomes (6)

  • Menopause-Specific Quality of Life Questionnaire (MENQOL)

    Basaline

  • Menopause Rating Scale (MRS)

    Basaline

  • Sociodemographic characteristics

    Basaline

  • Body Mass Index (BMI)

    Basaline

  • Body weight

    Basaline

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age30 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample in Ankara, Turkey

You may qualify if:

  • 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

You may not qualify if:

  • Women diagnosed with any psychological disorder
  • Cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06760, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 30, 2024

Study Start

January 1, 2023

Primary Completion

June 15, 2023

Study Completion

February 15, 2024

Last Updated

October 30, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations