Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062368) titled 'Effects of Chronic Glutamine Supplementation with Menstruation-Timed Iron and Vitamin C on Salivary Immune Markers and Countermovement Jump Performance in Physically Active Women' on July 28.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - National Taiwan University of Sport
Condition:
Condition - Salivary mucosal immune responses and countermovement jump performance following resistance exercise in healthy physically active women with regular menstrual cycles
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 24
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071377
Disclaimer: Curated by HT Syndication.