Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553963
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Athlete Biochemical Monitoring and Nutritional Support
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Biochemical Monitoring and Nutritional Support During Pre-Competition Weight Reduction in Female Weightlifters A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 athletes 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 gbag 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 gbag Origin Beijing China Weite Beijing Co Ltd Ingredients Soluble barley starch 62 g fructose 16-diphosphate 6 g electrolytes Dosage 1-2 bags during daily training Enhancing testosterone Nutritional supplement name Testosterone Synthesis Pump 1 capsule2 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 tablet05 grams Origin Beijing China Dongli Beijing Co Ltd Ingredients Vitamin B6 1600 mg100 g melatonin 500 mg100 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 630-730 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 scales reliability for Chinese subjects is between 065 and 084 and the validity is greater than 085
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 athletes 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 gbag 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 gbag Origin Beijing China Weite Beijing Co Ltd Ingredients Soluble barley starch 62 g fructose 16-diphosphate 6 g electrolytes Dosage 1-2 bags during daily training Enhancing testosterone Nutritional supplement name Testosterone Synthesis Pump 1 capsule2 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 tablet05 grams Origin Beijing China Dongli Beijing Co Ltd Ingredients Vitamin B6 1600 mg100 g melatonin 500 mg100 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 630-730 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 scales reliability for Chinese subjects is between 065 and 084 and the validity is greater than 085
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None