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

Overview

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.

Interventions

• Dietary supplement 400 mg CITRAPEAK® (glucosyl-hesperidin) supplementation
  The active intervention consists of 400 mg of glucosyl-hesperidin (CITRAPEAK®) in capsule form.
• Dietary supplement Placebo
  The placebo intervention consists of 400 mg/day of cellulose in capsule form, matching the appearance and dosage of active interventions.
• Dietary supplement 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.

Primary outcome measures

• Change from Baseline in Peak VO2 at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation [Time frame: Baseline and Week 8]
• Change from Baseline in Wingate Anaerobic Test Peak Anaerobic Power at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation [Time frame: Baseline and Week 8]
• Change from Baseline in Wingate Anaerobic Test Mean Anaerobic Power at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation [Time frame: Baseline and Week 8]
• Change from Baseline in Fatigue Rate at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation [Time frame: 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 [Time frame: 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) [Time frame: Baseline and Week 8, measured at 0, 30, and 60 minutes post-ingestion.]

Secondary outcome measures (6)

• 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline and Week 8]
• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation [Time frame: Baseline and Week 8]
• Change from Baseline in Plasma Nitric Oxide Levels at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation [Time frame: Baseline and Week 8]

Eligibility criteria

Inclusion criteria

• Participants who are between 18 - 50 years of age
• Body mass index values will range from >25.0 < 30.0 kg/m2
• 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
• Free-living and independent
• 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
• Willingness to maintain consistent sleep duration the evening before study visits
• 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
• Regular completion of at least 180 minutes of moderate to vigorous exercise per week for the past 6 months

Exclusion criteria

• Not currently completing at least 180 minutes of moderate to vigorous exercise per week for the past 6 months
• Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease
• Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals
• Has liver disease or some form of clinically diagnosed hepatic impairment
• Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
• Diagnosed with or is being treated for some form of thyroid disease
• Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year
• Diagnosed with some form of immune disorder (i.e., HIV/AIDS)
• History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
• 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)
• Positive medical history for any neurological condition or neurological disease
• 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.)
• 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
• 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.
• Participants who are lactating, pregnant or planning to become pregnant
• Have a known sensitivity or allergy to any of the study products
• History of alcohol or substance abuse in the 12 months prior to screening
• Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol
• Any orthopedic limitation that would prevent participation in a general fitness program
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Lindenwood University — Saint Charles

Identifiers

NCT: NCT06672952 · IRB-24-82

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗