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حالة التجربة السريرية NCT06672952 (HES) لـ أداء التمرين، Exercise Recovery، الوظيفة الإدراكية، Nitric Oxide، تدفق الدم، Endurance Exercise هي لم يبدأ التجنيد بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
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Dose-Response Impact of Glucosyl-Hesperidin (CitraPeak) on Exercise Performance, Blood Flow, Stress, Cognition, and Other Perceptual Indicators (HES)

لم يبدأ التجنيد بعد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06672952 (HES) هي دراسة تدخُّلية لـأداء التمرين، Exercise Recovery، الوظيفة الإدراكية، Nitric Oxide، تدفق الدم، Endurance Exercise وهي لم يبدأ التجنيد بعد. من المقرر أن يبدأ التسجيل في ١ رجب ١٤٤٦ هـ لتجنيد ٦٠ مشاركًا. يقودها Lindenwood University، ومن المتوقع اكتمالها بحلول ١٢ رجب ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢ جمادى الأولى ١٤٤٦ هـ.
الملخص
The purpose of this study is to evaluate the dose-dependent effects of glucosyl-hesperidin (CITRAPEAK) supplementation on exercise performance, recovery indicators, blood flow, cognitive function, mood, sleep, and fuel utilization in recreationally active adults.
وصف مفصل
This randomized, double-blind, placebo-controlled study investigates the effects of glucosyl-hesperidin (CITRAPEAK) on exercise performance, recovery, cognitive function, mood, and cardiovascular health in approximately 60 healthy, recreationally active adults aged 18-50. Participants will be assigned to one of three groups (placebo, 200mg CITRAPEAK, or 400mg CITRAPEAK) based on sex and baseline fat-free mass. Each participant will consume their assigned supplement daily for 8 weeks, with adherence tracked via supplementation logs. The study includes multiple visits, where participants will undergo a range of assessments, including exercise performance tests, blood flow analysis, and cognitive evaluations.
العنوان الرسمي

Dose-Response Impact of Glucosyl-Hesperidin (CitraPeak) on Exercise Performance, Blood Flow, Stress, Cognition, and Other Perceptual Indicators

الحالات الطبية
أداء التمرينExercise Recoveryالوظيفة الإدراكيةNitric Oxideتدفق الدمEndurance Exercise
معرّفات دراسة أخرى
  • HES
  • IRB-24-82
NCT معرّف
NCT06672952
تاريخ البدء (فعلي)
2025-01-01
آخر تحديث مُنشور
2024-11-04
تاريخ الاكتمال (المقدر)
2026-01-01
عدد المشاركين المخطط لهم
٦٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ التجنيد بعد
الكلمات الرئيسية
exercise performance
aerobic capacity
anaerobic power
mood
nitric oxide
cognitive function
glucosyl-hesperidin
training readiness
fuel utilization
endothelial function
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
ثلاثي
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/علاج
مقارن بالدواء الوهميPlacebo
Participants in this arm will receive a placebo supplement consisting of 400 mg of cellulose per day. The placebo is designed to match the appearance and dosage form of the active interventions, allowing for blinding in the study.
دواء وهمي
The placebo intervention consists of 400 mg/day of cellulose in capsule form, matching the appearance and dosage of active interventions.
تجريبية200 mg CITRAPEAK® (glucosyl-hesperidin) supplementation
Participants in this arm will receive a total of 200 mg of glucosyl-hesperidin (CITRAPEAK®) supplementation per day, along with an additional 200 mg of cellulose. This will provide a daily dosage of 400 mg, maintaining blinding to ensure the placebo effect is accounted for.
200 MG CITRAPEAK® (Glucosyl-hesperidin) Supplementation
The active intervention includes 200 mg of glucosyl-hesperidin (CITRAPEAK®) and an additional 200 mg of cellulose in capsule form.
تجريبية400 mg CITRAPEAK® (glucosyl-hesperidin) supplementation
Participants in this arm will receive a total of 400 mg of glucosyl-hesperidin (CITRAPEAK®) supplementation per day. This higher dose is intended to evaluate its effects on exercise performance, recovery, and cognitive function compared to the placebo and lower dose.
400 MG CITRAPEAK® (Glucosyl-hesperidin) Supplementation
The active intervention consists of 400 mg of glucosyl-hesperidin (CITRAPEAK®) in capsule form.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Change from Baseline in Peak VO2 at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
Peak VO2 will be measured as an indicator of maximal aerobic capacity. Higher values reflect improved cardiovascular performance.
Baseline and Week 8
Change from Baseline in Wingate Anaerobic Test Peak Anaerobic Power at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
Peak anaerobic power will be measured to assess maximal power output during high-intensity exercise. Higher values indicate improved anaerobic performance.
Baseline and Week 8
Change from Baseline in Wingate Anaerobic Test Mean Anaerobic Power at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
Wingate Anaerobic Test Mean anaerobic power will be recorded during repeated high-intensity exercise, with higher values indicating enhanced anaerobic endurance.
Baseline and Week 8
Change from Baseline in Fatigue Rate at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
Wingate Anaerobic Test Fatigue rate will be measured as the decline in power over time during anaerobic exercise, with a lower rate indicating improved endurance.
Baseline and Week 8
Change from Baseline in Perceived Indicators of Recovery, Training Readiness, Soreness, and Overall Feel Using Visual Analog Scales (VAS) at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
Perceived recovery, training readiness, soreness, recovery, and general "feel" will be self-rated using visual analog scales (VAS), with higher values indicating greater perceived improvements in each category.
Baseline and Week 8
Change from Baseline in Brachial Artery Blood Flow Measured 0, 30, and 60 Minutes After Acute and Prolonged Ingestion of Glucosyl-Hesperidin (CITRAPEAK)
Brachial artery blood flow will be measured to assess vascular response to CITRAPEAK at baseline and after 8 weeks of supplementation, with measurements taken at 0, 30, and 60 minutes post-ingestion.
Baseline and Week 8, measured at 0, 30, and 60 minutes post-ingestion.
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Change from Baseline in Carbohydrate and Fat Oxidation Rates at 30%, 40%, 50%, 60%, 70%, and 80% Peak VO2 During Exercise at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
Carbohydrate and fat oxidation rates will be measured at incremental intensities to assess fuel utilization during exercise, with higher fat oxidation indicating improved metabolic flexibility.
Baseline and Week 8
Change from Baseline in Stroop Color Matching Test Performance 0, 30, and 60 Minutes After Ingesting Dose 1 (Week 0) and Dose 56 (Week 8) Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
The Stroop color matching test will be conducted to assess cognitive processing speed and accuracy. Testing will occur at 0, 30, and 60 minutes after ingestion of the initial dose (Week 0) and the final dose (Week 8). Improved scores indicate enhanced cognitive performance.
0, 30, and 60 minutes post-ingestion at baseline and Week 8
Change from Baseline in Trail Making Test Performance 0, 30, and 60 Minutes After Ingesting Dose 1 (Week 0) and Dose 56 (Week 8) Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
The Trail Making Test will be conducted to evaluate cognitive flexibility and executive function. Testing will occur at 0, 30, and 60 minutes after ingestion of the initial dose (Week 0) and the final dose (Week 8). Faster completion times indicate improved cognitive function.
0, 30, and 60 minutes post-ingestion at baseline and Week 8
Change from Baseline in Profile of Mood States (POMS) Score at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
The Profile of Mood States (POMS) questionnaire will assess mood states across several domains, with lower scores indicating improved mood and well-being.
Baseline and Week 8
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
The Pittsburgh Sleep Quality Index (PSQI) will assess subjective sleep quality, with lower scores reflecting better sleep.
Baseline and Week 8
Change from Baseline in Plasma Nitric Oxide Levels at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
Plasma nitric oxide levels will be measured to evaluate changes in endothelial function, with higher levels suggesting improved vasodilation.
Baseline and Week 8
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
  1. Participants who are between 18 - 50 years of age
  2. Body mass index values will range from >25.0 < 30.0 kg/m2
  3. The average body mass index for entire study cohort will be less than 27.0 kg/m2. As such an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 27.0 kg/m2
  4. Free-living and independent
  5. In good health absent of being overweight or mildly obese with no other signs or symptoms of cardiovascular, respiratory, metabolic, immune, psychiatric, or musculoskeletal disease or disorders
  6. Willingness to maintain consistent sleep duration the evening before study visits
  7. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures
  8. Regular completion of at least 180 minutes of moderate to vigorous exercise per week for the past 6 months

  1. Not currently completing at least 180 minutes of moderate to vigorous exercise per week for the past 6 months
  2. Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease
  3. Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals
  4. Has liver disease or some form of clinically diagnosed hepatic impairment
  5. Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
  6. Diagnosed with or is being treated for some form of thyroid disease
  7. Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year
  8. Diagnosed with some form of immune disorder (i.e., HIV/AIDS)
  9. History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
  10. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)
  11. Positive medical history for any neurological condition or neurological disease
  12. Currently prescribed a statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.)
  13. Current smoker (average of > 1 pack per day within the past 3 months) has quit within the past six months. This includes all forms of nicotine
  14. Intake of any drugs (prescribed or over the counter) or dietary supplements that are known or are purported to weight loss such as thermogenics, hydroxycitric acid, ephedra, capsaicin, etc.
  15. Participants who are lactating, pregnant or planning to become pregnant
  16. Have a known sensitivity or allergy to any of the study products
  17. History of alcohol or substance abuse in the 12 months prior to screening
  18. Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol
  19. Any orthopedic limitation that would prevent participation in a general fitness program
  20. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
Lindenwood University logoLindenwood University
Increnovo, LLC logoIncrenovo, LLC
جهة اتصال مركزية للدراسة
جهة اتصال: Anthony M Hagele, MS, 636-949-4785, [email protected]
1 مواقع الدراسة في 1 بلدان

Missouri

Lindenwood University, Saint Charles, Missouri, 63301, United States
Anthony M Hagele, MS, جهة اتصال, 636-949-4785, [email protected]
Chad M Kerksick, PhD, جهة اتصال