UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062368 |
|---|---|
| Receipt number | R000071377 |
| Scientific Title | Study of the effects of high-intensity training on mucosal immunity, oxidative stress, inflammatory indicators and exercise ability in different stages of menstrual cycle and related nutrition strategies |
| Date of disclosure of the study information | 2026/07/28 |
| Last modified on | 2026/07/28 18:32:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Chronic Glutamine Supplementation with Menstruation-Timed Iron and Vitamin C on Salivary Immune Markers and Countermovement Jump Performance in Physically Active Women
Acronym
Glutamine Iron Menstruation Trial
Scientific Title
Study of the effects of high-intensity training on mucosal immunity, oxidative stress, inflammatory indicators and exercise ability in different stages of menstrual cycle and related nutrition strategies
Scientific Title:Acronym
Glutamine, Iron and Vitamin C Supplementation in Physically Active Women
Region
| Asia(except Japan) |
Condition
Condition
Salivary mucosal immune responses and countermovement jump performance following resistance exercise in healthy physically active women with regular menstrual cycles
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether chronic glutamine supplementation combined with menstruation-timed iron and vitamin C supplementation increases resting salivary secretory immunoglobulin A and lactoferrin secretion rates, maintains these responses following acute resistance exercise, and improves countermovement jump performance in physically active women with regular menstrual cycles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Co-primary outcomes were salivary secretory immunoglobulin A (SIgA) secretion rate and salivary lactoferrin (LF) secretion rate, measured using sandwich enzyme-linked immunosorbent assays and calculated as salivary concentration multiplied by salivary flow rate (ug/min). Outcomes were assessed before the supplementation intervention (Pre-rest), after the supplementation intervention immediately before exercise (Post-rest), immediately after the acute resistance exercise session (Post-T0), and 60 minutes after exercise (Post-T60). The primary intervention effect was assessed using the group-by-time interaction across the four measurement time points.
Key secondary outcomes
Secondary outcomes were salivary total protein concentration, salivary nitrite concentration, salivary flow rate, salivary cortisol concentration, salivary testosterone concentration, testosterone-to-cortisol ratio, and countermovement jump performance outcomes, including jump height, peak concentric power, peak concentric force, and reactive strength index-modified. These outcomes were assessed before the supplementation intervention (Pre-rest), after the supplementation intervention immediately before exercise (Post-rest), immediately after exercise (Post-T0), and 60 minutes after exercise (Post-T60). Salivary estradiol and progesterone concentrations were also assessed at Pre-rest and Post-rest to verify comparability of the menstrual-cycle phase between the two assessment sessions.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants consumed L-glutamine powder at a dose of 0.3 g/kg body mass/day, beginning after the baseline mid-luteal assessment and continuing until the day before the post-intervention mid-luteal assessment in the subsequent menstrual cycle. Beginning on the first day of the intervening menstrual bleeding, participants also consumed one capsule daily for 7 consecutive days. Each capsule provided 20 mg elemental iron as ferrous bisglycinate, 50 mg vitamin C, 290 ug folic acid, and 1.7 ug vitamin B12. All products were consumed with water immediately after waking.
Interventions/Control_2
Participants consumed maltodextrin powder at a dose matched to the body-mass-adjusted dose used in the supplement group. They also consumed one placebo capsule containing maltodextrin daily for 7 consecutive days, beginning on the first day of the intervening menstrual bleeding. The placebo products followed the same administration schedule and were identical in external appearance and packaging to the active products. All products were consumed with water immediately after waking.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Naturally menstruating women with regular menstrual cycles lasting 21 to 35 days during the 3 months preceding enrolment.
2. At least 6 months of regular exercise experience.
3. Willing and able to maintain usual training routines throughout the study.
4. Able to provide written informed consent and comply with the supplementation, menstrual-cycle tracking, exercise testing, and saliva collection procedures.
Key exclusion criteria
1. Use of hormonal contraceptives within the 3 months before enrolment.
2. Menstrual disorders, amenorrhea, or severe premenstrual symptoms during the previous 3 months.
3. Musculoskeletal injury within the preceding 3 months.
4. Use of medications or dietary supplements other than the study supplements during the experimental period.
5. Menstrual bleeding occurring outside the predefined mid-luteal-phase confirmation window after assessment.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shih-Hua |
| Middle name | |
| Last name | Fang |
Organization
National Taiwan University of Sport
Division name
Department of Sport Performance
Zip code
404401
Address
No. 16, Sec. 1, Shuangshi Rd., North Dist., Taichung City, Taiwan
TEL
8864222131082176
shfang@ntus.edu.tw
Public contact
Name of contact person
| 1st name | Cheng-Shiun |
| Middle name | |
| Last name | He |
Organization
National Chung Cheng University
Division name
Department of Athletics Sports
Zip code
621301
Address
No. 168, Sec. 1, University Rd., Minxiong Township, Chiayi County, Taiwan
TEL
8865272041137523
Homepage URL
cshe@ccu.edu.tw
Sponsor or person
Institute
National Taiwan University of Sport
Institute
Department
Personal name
Funding Source
Organization
National Science and Technology Council, Taiwan
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Taiwan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Jen-Ai Hospital
Address
483 Dong Rong Rd., Dali District, Taichung City 412, Taiwan
Tel
+886-4-2482-1771
jahirb@mail.jah.org.tw
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
National Taiwan University of Sport (Taichung, Taiwan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
https://katsu.suzu.w.waseda.jp/ISEI2026_Tokyo.html
Publication of results
Unpublished
Result
URL related to results and publications
https://katsu.suzu.w.waseda.jp/ISEI2026_Scientific%20Program_Updated%20regularly.pdf
Number of participants that the trial has enrolled
42
Results
The trial has been completed, and all prespecified outcomes have been analyzed. The combined nutritional supplementation intervention was associated with changes in selected salivary mucosal immune markers, whereas no clear intervention effect was observed for countermovement jump performance. No supplementation-related adverse events were reported. Detailed findings are being prepared for submission to a peer-reviewed journal.
Results date posted
| 2026 | Year | 07 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-six physically active women with regular menstrual cycles were included in the final analyses, with 17 participants in the supplement group and 19 in the placebo group. The groups were comparable in age, anthropometric characteristics, menstrual cycle duration, exercise habits, and strength characteristics at baseline.
Participant flow
Forty-eight women were assessed for eligibility. Six did not proceed to randomization, including five who withdrew for personal reasons and one who could not be contacted. Forty-two participants were randomized equally to the supplement and placebo groups. During follow-up, four participants in the supplement group and two in the placebo group were excluded because menstruation occurred outside the predefined study window. Therefore, 36 participants were included in the final analyses: 17 in the supplement group and 19 in the placebo group.
Adverse events
No adverse events related to the supplementation protocol were reported.
Outcome measures
Primary outcomes were salivary secretory immunoglobulin A secretion rate and salivary lactoferrin secretion rate. Secondary outcomes included salivary total protein concentration, nitrite concentration, salivary flow rate, salivary cortisol, salivary testosterone, testosterone-to-cortisol ratio, and countermovement jump outcomes including jump height, peak force, peak power, and reactive strength index-modified. Outcomes were assessed before supplementation, after supplementation before exercise, immediately after resistance exercise, and 60 minutes after exercise. Salivary estradiol and progesterone were assessed before and after the intervention to verify menstrual-cycle phase comparability.
Plan to share IPD
Individual participant data will not be publicly shared.
IPD sharing Plan description
De-identified individual participant data will not be made publicly available. Data may be considered for sharing upon reasonable request to the corresponding author, subject to approval by the research team and relevant ethics and institutional requirements.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
| 2025 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 25 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071377
