Clinical trial NCT06553963: Athlete Biochemical Monitoring and Nutritional Support
Official title: Biochemical Monitoring and Nutritional Support During Pre-Competition Weight Reduction in Female Weightlifters: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Weight Reduction
Lead sponsor: Chengdu Sport University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the efficacy of physiological and biochemical monitoring along with nutritional support in improving the performance and well-being of female weightlifters during the critical weight reduction phase before competition. It also seeks to determine the safety and potential benefits of the personalized nutritional interventions.

The primary questions this study aims to address are:

Does personalized nutritional support, informed by physiological and biochemical monitoring, reduce the incidence of fatigue and improve sleep quality in female weightlifters during the pre-competition period? How do serum indicators change in response to the nutritional interventions, and what does this indicate about the athletes' health and performance? What are the perceived benefits and any potential adverse effects reported by the participants receiving the nutritional support? To assess the impact of the intervention, researchers will compare the outcomes of the experimental group, which receives the tailored nutritional support, to those of the control group, which follows standard practices without additional intervention.

Participants will be required to:

Consume the nutritional supplements or maintain their regular diet as assigned for the duration of the 1-month study.

Attend scheduled visits to the research facility every two weeks for comprehensive health assessments, including blood tests for serum indicators and evaluations of fatigue levels and PSQI scores.

Record their daily experiences, including dietary adherence, training intensity, perceived fatigue, sleep patterns, and any other relevant observations in a personal diary.

By conducting this randomized controlled trial, the study will provide valuable insights into the role of targeted nutritional support in enhancing athletic performance and overall health during the demanding pre-competition weight reduction period.

Detailed description: The study took place from August to September 2024, spanning a total of 4 weeks. Initially, all participants followed their coaches' regular training plans for daily training (actual pre-competition training environment), without altering their personal routines or lifestyle habits.

On this foundation, participants in the experimental group received a four-week personalized nutritional monitoring and supplementation program. This program was tailored by sports nutrition experts according to each athlete's biochemical indicators, body weight, training load, and personal dietary habits. It specifically included, but was not limited to: Nutritional Assessment, where a detailed nutritional evaluation was conducted for each athlete before the start of the study, including dietary history, biochemical indicator analysis, etc.; Dietary Logs, where athletes were asked to record their daily food intake to allow the nutrition team to monitor and adjust in real time; Nutritional Consultations: Weekly face-to-face consultations with nutrition experts to discuss dietary plans and resolve any questions or issues; Nutritional Supplements: Adjusting the types and dosages of nutritional supplements based on weekly biochemical monitoring results, aimed at optimizing athletes' biochemical indicators, such as reducing blood urea and cortisol, and increasing hemoglobin (Nutritional supplement name: Zinc Magnesium Multi-Vitamin Sports Nutrition Powder, 180 g/bag; Origin: Beijing, China, Winpowerdata Technology (Beijing) Co., Ltd.; Ingredients: Rice bran lipid alcohol, magnesium, zinc, vitamin C, taurine, vitamin B1, vitamin B2, vitamin B6; Dosage: 1-2 bags daily); Reducing creatine kinase (Nutritional supplement name: Endurance Sugar Pump, 70 g/bag; Origin: Beijing, China, Weite Beijing Co., Ltd.; Ingredients: Soluble barley starch 62 g, fructose 1,6-diphosphate 6 g, electrolytes; Dosage: 1-2 bags during daily training); Enhancing testosterone (Nutritional supplement name: Testosterone Synthesis Pump, 1 capsule/2 grams; Origin: Beijing, China, Weite Beijing Co., Ltd.; Ingredients: Super testosterone complex, testosterone action amplification factor, testosterone receptor sensitizer, 5-level male testosterone optimization factor, aspartic acid, Rhodiola; Dosage: 6 capsules before daily training); Promoting sleep (Nutritional supplement name: Melatonin Tablets, 1 tablet/0.5 grams; Origin: Beijing, China, Dongli Beijing Co., Ltd.; Ingredients: Vitamin B6, 1600 mg/100 g, melatonin, 500 mg/100 g; Dosage: 1 tablet before bedtime); Control group participants continued to follow their regular diet and training plan without additional nutritional intervention.

This study conducted 5 tests on all participants, at baseline (before weight reduction), week one, week two, week three, and week four (1-2 days before the competition). The time was fixed on Sunday (6:30-7:30 AM). The Pittsburgh Sleep Quality Index (PSQI) test was conducted twice (at baseline and week four).

Serum Testing: Approximately 2 ml of fasting venous blood was taken from the participants' elbow. Beckman Coulter Automated Biochemical Analyzer (California, USA) was used to measure blood urea and creatine kinase, Beckman Coulter Chemiluminescence Immunoassay Analyzer (California, USA) was used to measure blood testosterone and cortisol, and HemoCue Hb 301 Hemoglobinometer (Sweden) was used to measure hemoglobin.

Scale Testing: Participants' fatigue scores were tested, with participants asked to mark their fatigue score on a 10 cm line, with the far left indicating no fatigue and the far right indicating severe fatigue. The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire used to assess the sleep quality of the subject over the past month, composed of 18 self-rated items forming 7 components, with a total score ranging from 0 to 21 points, the higher the score, the worse the sleep quality. The scale's reliability for Chinese subjects is between 0.65 and 0.84, and the validity is greater than 0.85

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 30 years old
* At least 5 years of professional weightlifting training experience
* Currently undergoing systematic training
* Passed a health examination
* The study complies with the Declaration of Helsinki and signed an informed consent form.

Exclusion Criteria:

* Obvious injuries to the lower limb joints
* Taking prescription medications (such as those affecting mood and sleep)
* Abnormal cardiovascular function.

Primary outcomes:
measure: Serum Testing: blood urea
timeFrame: 28 Days
measure: Serum Testing: creatine kinase
timeFrame: 28 Days
measure: Serum Testing: blood testosterone
timeFrame: 28 Days
measure: Serum Testing: cortisol
timeFrame: 28 Days
measure: Serum Testing: hemoglobin
timeFrame: 28 Days
measure: Scale Testing: fatigue scores
timeFrame: 28 Days
measure: Scale Testing: Pittsburgh Sleep Quality Index
timeFrame: 28 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chengdu Sport University
name: Liang Cheng, Dr
role: STUDY_CHAIR
References: