Athlete Biochemical Monitoring and Nutritional Support

NCT06553963 | Not Yet Recruiting

• 1 other identifier: SSC20246
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weight Reduction

Outcome Measures

Primary Outcomes (7)

• Serum Testing: blood urea

  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.

  28 Days

• Serum Testing: creatine kinase

  Approximately 2 ml of fasting venous blood was taken from the participants' elbow. Beckman Coulter Automated Biochemical Analyzer (California, USA) was used to measure creatine kinase.

  28 Days

• Serum Testing: blood testosterone

  Beckman Coulter Chemiluminescence Immunoassay Analyzer (California, USA) was used to measure blood testosterone.

  28 Days

• Serum Testing: cortisol

  Beckman Coulter Chemiluminescence Immunoassay Analyzer (California, USA) was used to measure blood cortisol.

  28 Days

• Serum Testing: hemoglobin

  HemoCue Hb 301 Hemoglobinometer (Sweden) was used to measure hemoglobin.

  28 Days

• Scale Testing: fatigue scores

  Participants were requested to assess their level of fatigue using the Visual Analogue Scale (VAS) for Fatigue, a validated measurement tool. On the VAS, a 10 cm line is marked, where '0' cm represents no fatigue and '10' cm represents the most severe fatigue possible. Higher scores on this scale indicate a greater degree of fatigue, with lower scores reflecting less fatigue.

  28 Days

• Scale Testing: Pittsburgh Sleep Quality Index

  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.

  28 Days

Study Arms (2)

Control group

NO INTERVENTION

All participants followed their coaches' regular training plans for daily training (actual pre-competition training environment), without altering their personal routines or lifestyle habits.

Experimental group

EXPERIMENTAL

Participants in the experimental group received a four-week tailored nutrition program, developed by sports nutritionists based on athletes' biochemical profiles, body weight, training intensity, and dietary habits. The program included: Daily Dietary Logs: Monitoring food intake for immediate nutritional adjustments. Weekly Nutritional Consultations: Strategy refinement discussions with experts. Customized Nutritional Supplements: "Zinc Magnesium Multi-Vitamin Sports Nutrition Powder" was used to improve blood urea, cortisol, and hemoglobin levels, containing ingredients like rice bran lipid alcohol, magnesium, zinc, and B vitamins. Performance-Specific Supplements: "Endurance Sugar Pump" to lower creatine kinase levels during training and "Testosterone Synthesis Pump" to enhance testosterone, both by Weite Beijing Co., Ltd. Sleep Aid: "Melatonin Tablets" to ensure restful sleep, containing vitamin B6 and melatonin, produced by Dongli Beijing Co., Ltd.

Other: Control group; Other: Experimental group

Interventions

Control group OTHER

The control group maintained their regular diet and training without additional nutritional support.

Experimental group

Experimental group OTHER

Biochemical Monitoring and Nutritional Support

Experimental group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chengdu Sport University: lead

MeSH Terms

Conditions

Weight Loss

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Liang Cheng, Dr

  Chengdu Sport University

  STUDY CHAIR

Central Study Contacts

Liang Cheng, Dr

CONTACT

+8613518196070; xuelilantian@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: August 20, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share