Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT03854786
  4. Details
NCT03854786 Clinical Trial

Aerobic Fitness in Overweight and Obese Individuals

Healthy Clinical Trial

Official title:
A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03854786
Other study ID # EB/181201/OXYJUN/EVRG
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 3, 2020
Est. completion date May 28, 2020

Study information
Verified date January 2020
Source Vedic Lifesciences Pvt. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Oxyjun is known for improving cardiovascular endurance. Overweight and obese individuals are at increased risk of cardiovascular complications. To lower the risk, these individuals need to remain physically active with acceptable aerobic fitness. Hence, the objective of the study is to investigate the effect of Oxyjun on aerobic fitness in physically active overweight and obese individuals. All subjects in the study will be tested for maximum aerobic capacity , body composition, and serum biomarker for fitness.

Recruitment information / eligibility
Status Terminated
Enrollment 11
Est. completion date May 28, 2020
Est. primary completion date March 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Body Mass Index = 25 - = 34.9 kg/m2. - Waist Circumference = 80 cms. - Non-smoker. - BP = 140/90 mm Hg - FBS = 125 mg/dl - Hb = 11 g/ dl - Can abstain from strenuous exercise and alcohol for at least 48 hours. - Can abstain from caffeine for at least 24 hours. Exclusion Criteria: - Participants with history of regular (=2 times a week) structured exercise (gym, walking, yoga, etc). - Inter-arm blood pressure is =10 mm Hg. - Known cases of type II Diabetes Mellitus. - Known cases of hypertension with or without anti-hypertensive medication. - Visual or balance problems, or who cannot walk on a treadmill without using the handrails.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oxyjun
Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.
• Pacebo
Methyl Crystalline Cellulose

Locations
Country Name City State
India Vedic Lifesciences Pvt. Ltd Mumbai Opp Infinity Mall

Sponsors (1)
Lead Sponsor Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals Measured by change in VO2 max From baseline to Day 56
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1