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| Name | Class |
|---|---|
| Increnovo LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
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| 200 mg CITRAPEAK® (glucosyl-hesperidin) supplementation | Experimental | 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. |
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| 400 mg CITRAPEAK® (glucosyl-hesperidin) supplementation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 mg CITRAPEAK® (glucosyl-hesperidin) supplementation | Dietary Supplement | The active intervention consists of 400 mg of glucosyl-hesperidin (CITRAPEAK®) in capsule form. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony M Hagele, MS | Contact | 636-949-4785 | ahagele@lindenwood.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chad M Kerksick, PhD | Lindenwood University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindenwood University | Recruiting | Saint Charles | Missouri | 63301 | United States |
We do not plan to share IPD
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This study employs a double-blind design to ensure that participants, investigators, and outcome assessors remain unaware of the group assignments. All supplements (placebo and both doses of CITRAPEAK®) are provided in identical capsules, containing either 400 mg of cellulose (placebo), 200 mg of CITRAPEAK® with 200 mg of cellulose, or 400 mg of CITRAPEAK®. Each participant is assigned a unique randomization code, which is used to label the capsules, maintaining blinding throughout the study. Only the study designated unblinded personnel have access to the randomization key, ensuring that the blinding remains intact for all other study staff.
| Placebo | Dietary Supplement | The placebo intervention consists of 400 mg/day of cellulose in capsule form, matching the appearance and dosage of active interventions. |
|
| 200 mg CITRAPEAK® (glucosyl-hesperidin) supplementation | Dietary Supplement | The active intervention includes 200 mg of glucosyl-hesperidin (CITRAPEAK®) and an additional 200 mg of cellulose in capsule form. |
|
| 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. |
| 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 |
| ID | Term |
|---|---|
| C487382 | glucosyl hesperidin |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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