To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.

NCT05621395 | Completed

• 1 other identifier: EB/220604/OXY/FATIGUE
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 4

Brief Summary

E-OJ-01 (Oxyjun®), a proprietary, standardized aqueous extract of TA, has been proven to improve cardiac output and thereby lead to better oxygenation capacity and exercise endurance. This, in turn, averts fatigue and improves physical functioning. Based on the previous studies of E-OJ-01 and the scientific literature available in support of the antioxidant and anti- inflammatory activity of TA bark, in the present study, it is hypothesized that E-OJ-01 will be able to reduce fatigue and improve the cardiorespiratory fitness of the male participants aged between 30 to 60 years.

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  To determine the effect of 60 days of product on exercise capacity as assessed by change in time-to-exhaustion (TTE) as evaluated by the Borg RPE scale while running on a treadmill using the Modified Bruce treadmill test protocol compared to the placebo. It is a 15-point single-item scale ranging from 6 to 20, with anchors ranging from 6 "No exertion" to 20 "Maximum exertion"The Borg Score of ≥ 19 will indicate the point of volitional exhaustion, and the exercise protocol will be terminated at this point.

  Day 0 baseline to Day 60

Secondary Outcomes (6)

• Cardiorepiratory fitness

  Day 0 and Day 60

• Exercise-induced fatigue and energy levels

  Day 0 and Day 60

• General fatigue

  Day 0, Day 15, Day 30 and Day 60

• Physical fatigue

  Day 0, Day 15, Day 30 and Day 60

• Heart rate at maximal fatigue

  Day 0 and Day 60

Study Arms (2)

E-OJ-01

EXPERIMENTAL

1 capsule (400 mg) orally to be taken after breakfast daily for 60 days

Other: E-OJ-01

Microcrystalline cellulose

PLACEBO COMPARATOR

1 capsule (400 mg) orally to be taken after breakfast daily for 60 days

Other: Microcrystalline cellulose

Interventions

E-OJ-01 OTHER

1 capsule (400 mg) orally to be taken after breakfast daily for 60 days

E-OJ-01

Microcrystalline cellulose OTHER

1 capsule (400 mg) orally to be taken after breakfast daily for 60 days

Microcrystalline cellulose

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males aged ≥30 to ≤60 years.
• Body mass index (BMI) ≥18 and ≤29.9 kg/m2
• VO2 max ≥20 ml/kg/ min but ≤35 ml /min/kg.
• FAS total score ≥22.
• Systolic blood pressure (SBP) ≤130 mm Hg and diastolic blood pressure (DBP) ≤89 mm Hg.
• Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit.
• Individuals who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule).
• Individuals who are literate enough to understand the purpose of the study and their rights.
• Individuals who can give written informed consent and are willing to participate in the study.

You may not qualify if:

• Individuals with a history of any pulmonary disorder.
• Known cases of hypertension and diabetes mellitus.
• SpO2 \< 96%
• Random blood glucose (RBG) levels ≥140 mg/dl.
• Hemoglobin (Hb) \<13.0 g/dl.
• Abnormal thyroid stimulating hormone (TSH) value (\<0.4μIU/ml or \>4.2μIU/ml).
• Individuals with a history of COVID-19 in the last 3 months.
• Individuals currently on/or having a history of taking blood lipid-lowering medications.
• Individuals who are unable to run due to any joint disorder.
• History of smoking or active smokers using any form of tobacco.
• Individuals with substance abuse problems (within two years) defined as:
• Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
• High-risk drinking as defined as consuming 5 or more alcohol-containing drinks on any day or 15 or more alcohol-containing drinks per week.
• Individuals who are currently on dietary supplements.
• Individuals who are currently on diuretics.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (4)

D.Y. Patil deemed to be University,

Nerul, Maharashtra, 400706, India

Location

Dr. Preeti Bawaskar's Clinic

Thane, Maharashtra, 400607, India

Location

Shree Ashirwad Hospital

Thane, Maharashtra, 421207, India

Location

Jaipur National University Institute for Medical Science and Research Centre

Jaipur, Rajasthan, 302017, India

Location

MeSH Terms

Conditions

Fatigue

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Shalini Srivastava, MD medicine

  Vedic Lifesciences Pvt. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Sequentially numbered, sealed, opaque envelopes
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel Group, Placebo Controlled Trial

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 18, 2022
• Study Start: November 29, 2022
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

IN (4)