Clinical trial NCT06672952: Dose-Response Impact of Glucosyl-Hesperidin (CitraPeak) on Exercise Performance, Blood Flow, Stress, Cognition, and Other Perceptual Indicators
Official title: Dose-Response Impact of Glucosyl-Hesperidin (CitraPeak) on Exercise Performance, Blood Flow, Stress, Cognition, and Other Perceptual Indicators
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise Performance
Exercise Recovery
Cognitive Function
Nitric Oxide
Blood Flow
Endurance Exercise
Keywords: exercise performance
aerobic capacity
anaerobic power
mood
nitric oxide
cognitive function
glucosyl-hesperidin
training readiness
fuel utilization
endothelial function
Lead sponsor: Lindenwood University
Sponsor class: OTHER
Collaborators: name: Increnovo, LLC
First posted: 2024-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Peak VO2 at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
timeFrame: Baseline and Week 8
measure: Change from Baseline in Wingate Anaerobic Test Peak Anaerobic Power at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
timeFrame: Baseline and Week 8
measure: Change from Baseline in Wingate Anaerobic Test Mean Anaerobic Power at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
timeFrame: Baseline and Week 8
measure: Change from Baseline in Fatigue Rate at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
timeFrame: Baseline and Week 8
measure: 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
timeFrame: Baseline and Week 8
measure: Change from Baseline in Brachial Artery Blood Flow Measured 0, 30, and 60 Minutes After Acute and Prolonged Ingestion of Glucosyl-Hesperidin (CITRAPEAK)
timeFrame: Baseline and Week 8, measured at 0, 30, and 60 minutes post-ingestion.
Secondary outcomes:
measure: 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
timeFrame: Baseline and Week 8
measure: 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
timeFrame: 0, 30, and 60 minutes post-ingestion at baseline and Week 8
measure: 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
timeFrame: 0, 30, and 60 minutes post-ingestion at baseline and Week 8
measure: Change from Baseline in Profile of Mood States (POMS) Score at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
timeFrame: Baseline and Week 8
measure: Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
timeFrame: Baseline and Week 8
measure: Change from Baseline in Plasma Nitric Oxide Levels at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: St. Charles
country: United States
facility: Lindenwood University
state: Missouri
Study officials:
affiliation: Lindenwood University
name: Chad M Kerksick, PhD
role: PRINCIPAL_INVESTIGATOR
References: