Weight ReductionNCT06553963
Athlete Biochemical Monitoring and Nutritional Support
A study testing Experimental group in people with Weight Reduction, run by Chengdu Sport University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Reduction
- What is being tested?
- Experimental group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Obvious injuries to the lower limb joints
- Taking prescription medications (such as those affecting mood and sleep)
- Abnormal cardiovascular function.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Biochemical Monitoring and Nutritional Support During Pre-Competition Weight Reduction in Female Weightlifters: A Randomized Controlled Trial
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:
Read more
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.
Read the 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
- Conditions
- Weight Reduction
- Being tested
- Control group, Experimental group
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
The control group maintained their regular diet and training without additional nutritional support.
Experimental groupOther
Biochemical Monitoring and Nutritional Support
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Control group; Other: Experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 Days
Serum Testing: blood testosterone
Beckman Coulter Chemiluminescence Immunoassay Analyzer (California, USA) was used to measure blood testosterone.
Measured: 28 Days
Serum Testing: cortisol
Beckman Coulter Chemiluminescence Immunoassay Analyzer (California, USA) was used to measure blood cortisol.
Measured: 28 Days
Serum Testing: hemoglobin
HemoCue Hb 301 Hemoglobinometer (Sweden) was used to measure hemoglobin.
Measured: 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.
Measured: 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.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Liang, Chengdu Sport University
- Investigators
- Liang Cheng, Dr, Study chair, Chengdu Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553963
- Sponsor's protocol ID
- SSC20246
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Monitoring and Nutritional Support During Pre-Competition Weight Reduction in Female Weightlifters: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06553963
- Acronym / sponsor ID
- SSC20246
- Conditions
- Weight Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Chengdu Sport UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Control group, Other: Experimental groupParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Obvious injuries to the lower limb joints
- Taking prescription medications (such as those affecting mood and sleep)
- Abnormal cardiovascular function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupThe control group maintained their regular diet and training without additional nutritional support. | Other | Experimental group |
| Experimental groupBiochemical Monitoring and Nutritional Support | Other | Experimental group |
Primary outcome
Serum Testing: blood urea
Time frame: 28 Days
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.
Serum Testing: creatine kinase
Time frame: 28 Days
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.
Serum Testing: blood testosterone
Time frame: 28 Days
Beckman Coulter Chemiluminescence Immunoassay Analyzer (California, USA) was used to measure blood testosterone.
Serum Testing: cortisol
Time frame: 28 Days
Beckman Coulter Chemiluminescence Immunoassay Analyzer (California, USA) was used to measure blood cortisol.
Serum Testing: hemoglobin
Time frame: 28 Days
HemoCue Hb 301 Hemoglobinometer (Sweden) was used to measure hemoglobin.
Scale Testing: fatigue scores
Time frame: 28 Days
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.
Scale Testing: Pittsburgh Sleep Quality Index
Time frame: 28 Days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang Cheng, Dr study chair
Chengdu Sport University
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Weight Reduction, run by Chengdu Sport University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Cheng, Dr (+8613518196070, xuelilantian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Testing: blood urea (time frame: 28 Days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.