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

Lindenwood University

Status: Not yet enrolling

Conditions: Exercise Recovery; Cognitive Function; Exercise Performance; Blood Flow; Nitric Oxide; Endurance Exercise

Treatments: Dietary Supplement: Placebo; Dietary Supplement: 200 mg CITRAPEAK® (glucosyl-hesperidin) supplementation; Dietary Supplement: 400 mg CITRAPEAK® (glucosyl-hesperidin) supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06672952

IRB-24-82

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

200 mg CITRAPEAK® (glucosyl-hesperidin) supplementation

Experimental group

Description:

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.

Treatment:

Dietary Supplement: 200 mg CITRAPEAK® (glucosyl-hesperidin) supplementation

400 mg CITRAPEAK® (glucosyl-hesperidin) supplementation

Experimental group

Description:

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.

Treatment:

Dietary Supplement: 400 mg CITRAPEAK® (glucosyl-hesperidin) supplementation