Glucosyl-Hesperidin for Exercise Performance

(HES Trial)

Overseen By Anthony M Hagele, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Lindenwood University

Must not be taking: Statins, Hypertension medications, Weight loss drugs

Disqualifiers: Heart disease, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

Trial Summary

Do I need to stop taking my current medications for this trial?

If you are currently taking statin drugs or hypertension medications, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the study team.

What evidence supports the effectiveness of the treatment Glucosyl-Hesperidin (CitraPeak) for improving exercise performance?

Research shows that glucosyl hesperidin, a more soluble form of hesperidin, improved low-intensity running performance in rats. Additionally, studies on hesperidin have shown it can enhance exercise performance and antioxidant status in amateur cyclists, suggesting potential benefits for exercise performance. ^{1 2 3 4 5}

Is Glucosyl-Hesperidin safe for human use?

Research on 2S-hesperidin, a form of hesperidin similar to glucosyl-hesperidin, shows it has antioxidant and anti-inflammatory effects in humans, with no reported safety concerns in the studies reviewed. However, specific safety data for glucosyl-hesperidin in humans is not detailed in the available research. ^{1 2 3 4 6}

How does the drug Glucosyl-Hesperidin (CitraPeak) differ from other treatments for exercise performance?

Glucosyl-Hesperidin is unique because it is a modified form of hesperidin that is 10,000 times more soluble and has 3.7 times higher bioavailability, making it more effective in improving low-intensity exercise performance by enhancing energy generation in muscles. ^{1 2 4 5 6}

What is the purpose of this trial?

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.

Research Team

Chad M Kerksick, PhD

Principal Investigator

Lindenwood University

Eligibility Criteria

This trial is for recreationally active adults interested in the potential benefits of CitraPeak on exercise performance and recovery. Participants should be healthy with no major medical issues that affect blood flow, stress levels, cognition, or exercise ability.

Inclusion Criteria

The average body mass index for entire study cohort will be less than 27.0 kg/m2. 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

I am in good health, not overweight or mildly obese, with no chronic diseases.

Willingness to maintain consistent sleep duration the evening before study visits

Exclusion Criteria

I have liver disease or a diagnosed liver condition.

I have been diagnosed with or am being treated for thyroid disease.

I have been diagnosed with diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily supplementation of glucosyl-hesperidin (CITRAPEAK) for 8 weeks, with assessments including exercise performance tests, blood flow analysis, and cognitive evaluations

8 weeks

Multiple visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Glucosyl-Hesperidin (CitraPeak)

Trial Overview The study tests if different doses of CitraPeak (400 mg and 200 mg) improve endurance, cognitive function, mood, sleep quality compared to a placebo. It's designed to see how the body responds after taking these supplements over time.

Participant Groups

Group I: 400 mg CITRAPEAK® (glucosyl-hesperidin) supplementation Experimental Treatment 1 Intervention

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.

Group II: 200 mg CITRAPEAK® (glucosyl-hesperidin) supplementation Experimental Treatment 1 Intervention

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.

Group III: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Lindenwood University

Lead Sponsor

Trials

22

Recruited

830+

Increnovo, LLC

Collaborator

Trials

4

Recruited

170+

Increnovo, LLC

Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Improvement of low-intensity long-time running performance in rats by intake of glucosyl hesperidin. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Acute Effects of Hesperidin in Oxidant/Antioxidant State Markers and Performance in Amateur Cyclists. [2020]

3. England pubmed.ncbi.nlm.nih.gov

8 weeks of 2S-hesperidin prevents a decrease in pO2 at submaximal intensity in amateur cyclists in off-season: randomized controlled trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

8-Week Supplementation of 2S-Hesperidin Modulates Antioxidant and Inflammatory Status after Exercise until Exhaustion in Amateur Cyclists. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic Supplementation of 2S-Hesperidin Improves Acid-Base Status and Decreases Lactate at FatMax, at Ventilatory Threshold 1 and 2 and after an Incremental Test in Amateur Cyclists. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of glucosyl-hesperidin and physical training on body weight, plasma lipids, oxidative status and vascular reactivity of rats fed with high-fat diet. [2022]