Development and evaluation of a health-promoting meal for late middle-aged women in menopause
| ISRCTN | ISRCTN11827482 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11827482 |
| Secondary identifying numbers | EUMC 2020-02-047 |
- Submission date
- 12/10/2025
- Registration date
- 16/10/2025
- Last edited
- 15/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Menopause is a critical transition in a woman’s life, characterized by hormonal changes such as increased follicle-stimulating hormone (FSH) and decreased estradiol (E2). These changes often lead to menopausal symptoms, including sleep disturbances and depressive mood, which substantially affect health and quality of life in late middle-aged women. Moreover, this period is associated with an increased risk of chronic diseases, highlighting the importance of appropriate health management and promotion of well-being.
Previous studies have shown that a balanced dietary pattern, with adequate consumption of diverse foods, has positive effects on alleviating menopausal symptoms and preventing chronic diseases in late middle-aged women. In particular, sufficient intake of calcium, omega-3 fatty acids, dietary fiber, and isoflavones has been reported to be closely linked with reducing chronic disease risk in this population.
Therefore, the aim of this study is to develop and implement a health-promoting meal plan enriched with these key nutrients (calcium, omega-3 fatty acids, dietary fiber, and isoflavones) and to evaluate its effects on improving health outcomes among late middle-aged women.
Who can participate?
Women aged between 50 and 65 years.
What does the study involve?
All participants were provided with a health-promoting meal plan for 8 weeks and, their nutritional intake was monitored during the intervention period. Menopausal symptoms, sleep quality, body measurements, blood parameters, continuous glucose monitoring, and plasma and urine metabolomics were assessed before and after the intervention.
What are the possible benefits and risks of participating?
Participants may have benefited from following a meal plan developed to promote health and improve metabolic outcomes. No major risks were reported. Minor risks included slight discomfort or inconvenience from blood sample collection.
Where is the study run from?
Ewha Clinical Trial Center, Ewha Womans University Mokdong Hospital (South Korea)
When is the study starting and how long is it expected to run for?
January 2019 to September 2021
Who is funding the study?
Ewha Womans University and Dr. Kitchen Co., Ltd. (South Korea)
Who is the main contact?
Dr. Yangha Kim
yhmoon@ewha.ac.kr
Contact information
Principal investigator
Department of Nutritional Science and Food Management, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu
Seoul
03760
Korea, South
 ORCID ID |
0000-0002-7280-7597 |
|---|---|
| Phone | +82 2-3277-3101 |
| yhmoon@ewha.ac.kr |
Principal investigator
Department of Environmental Medicine, Ewha Womans University College of Medicine, 25, Magokdong-ro 2-gil, Gangseo-gu
Seoul
07804
Korea, South
| ORCID ID |
0000-0002-4224-3858 |
|---|---|
| Phone | +82 2-6986-6013 |
| eunheeha@ewha.ac.kr |
Public, Scientific, Principal investigator
Department of Nutritional Science and Food Management, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu
Seoul
03760
Korea, South
| ORCID ID |
0000-0001-6999-4996 |
|---|---|
| Phone | +82 2-3277-6533 |
| park.yoonjung@ewha.ac.kr |
Study information
| Study design | Single-arm pre-post interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home, Hospital |
| Study type | Treatment, Efficacy |
| Participant information sheet | 48172 Participant information sheet.pdf |
| Scientific title | Impact of a tailored meal plan on metabolic health in late middle-aged women: an 8-week pre-post intervention trial |
| Study objectives | To investigate the effect of a health-promoting meal plan on metabolic health outcomes in late middle-aged postmenopausal women. |
| Ethics approval(s) |
Approved 05/10/2020, Ewha Womans University Mokdong Hospital (1071, Anyangcheon-ro, Yangcheon-gu, Seoul, Republic of Korea, Seoul, 07985, Korea, South; +82 2-2650-2019; Irb-mok@eumc.ac.kr), ref: EUMC 2020-02-047 |
| Health condition(s) or problem(s) studied | Late middle-aged postmenopausal women |
| Intervention | Sixty-one participants underwent the intervention and were provided with a health-promoting meal plan for 8 weeks. The meal plan was developed by registered dietitians to enrich four major nutrients (calcium, omega-3, fiber, and isoflavone) that showed insufficient intake in late middle-aged women. Meals were supplied as two meals per day (lunch, dinner) and one snack, designed to provide approximately 80% of the estimated daily energy requirement. The meals were provided in the form of meal kits with accompanying recipe cards. Participants were instructed to prepare and consume meals at regular times according to their individual eating schedules, with a simple breakfast being recommended. Participants were assessed before and after intervention for menopausal symptoms, sleep quality, anthropometric indices, blood parameters, continuous glucose monitoring, and plasma and urine metabolomics. |
| Intervention type | Other |
| Primary outcome measure | Blood metabolic health markers (glucose and lipid parameters) will be measured at baseline and 8 weeks using standard enzymatic and immunoturbidimetric assays. |
| Secondary outcome measures | 1. Menopausal symptoms measured using the Kupperman Index and Pittsburgh Sleep Quality Index (PSQI) at baseline and 8 weeks 2. Hormone levels (estradiol [E2] and follicle-stimulating hormone [FSH]) measured using chemiluminescence microparticle immunoassay and electrochemiluminescence microparticle immunoassay at baseline and 8 weeks 3. Continuous glucose monitoring (CGM) measured using iPro2 (Medtronic Diabetes, Northridge, CA, USA) at baseline and 8 weeks 4. Plasma and urine metabolomics measured using GC-TOF-MS at baseline and 8 weeks 5. Nutritional intake measured using mobile application during 8 weeks intervention period |
| Overall study start date | 30/01/2019 |
| Completion date | 17/09/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 60 |
| Total final enrolment | 65 |
| Key inclusion criteria | 1. Women aged >50 and <65 years 2. Subjects with a low intake level of at least one of the target nutrients, below the Korean dietary recommendations (75 mg isoflavones, 2.0 g omega-3 fatty acids, 18.8 g dietary fiber, and 600 mg calcium), as assessed by a 3-day dietary survey (2 weekdays and 1 weekend day) |
| Key exclusion criteria | 1. Subjects with hypersensitivity to specific foods or ingredients 2. Subjects with difficulty using smartphones |
| Date of first enrolment | 07/06/2021 |
| Date of final enrolment | 01/07/2021 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Seoul
07985
Korea, South
Sponsor information
University/education
Department of Nutritional Science and Food Management
52, Ewhayeodae-gil, Seodaemun-gu
Seoul
03760
Korea, South
| Phone | +82 2-3277-3085 |
|---|---|
| e600024@ewha.ac.kr | |
| Website | http://www.ewha.ac.kr/mbs/ewhaen/ |
"ROR" |
https://ror.org/053fp5c05 |
Hospital/treatment centre
Ewha Clinical Trial Center
1071, Anyangcheon-ro, Yangcheon-gu
Seoul
07985
Korea, South
| Phone | +82 2-2650-5114 |
|---|---|
| info@ewhactc.co.kr | |
| Website | https://mokdong.eumc.ac.kr |
|
"ROR" |
https://ror.org/00ypk0v12 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Ewha
- Location
- Korea, South
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets are not expected to be made available because participant consent and IRB approval did not cover public data sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 15/10/2025 | No | Yes |
Additional files
Editorial Notes
15/10/2025: Trial's existence confirmed by Ewha Womans University Mokdong Hospital.
