None listed
Conditions
Interventions
Intervention1: Red + green spinach extract (SpinoleRG ) capsules: Two 400 mg capsules (each containing 200 mg of red spinach extract and 200 mg of green spinach extract), in sequence, 30-60 minutes b
Sponsors
PhytoVeda Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female participants aged between 18-40 years having a BMI between 25-30 kg per meter square. (both inclusive) 2.Resting blood pressure averaging less than 140 per 90 mmHg. 3.Not on any medication for cardiovascular and metabolic disorders. 4.Engaged in regular resistance training (comprising cardio and strength training) for 6 months to 1 year and willing to continue the same during the study. 5.Participants who are physically active, follow or are willing to maintain a stable, healthy, and balanced diet (adequate carbohydrates, proteins, and fats), and agree to refrain from initiating any new or fad dietary regimens or programs during the study. 6.Participants posing a sufficient level of knowledge regarding the importance of dietary and lifestyle factors relevant to the study, as determined by the investigator. 7.Participants who are willing to discontinue the use of mouthwash for the duration of the study. 8.Willing to provide consent and come for regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Participants with any acute illness requiring immediate medical care. 2.Participants with a medical condition where ALT or AST levels are more than 3 times the upper normal limit or uncontrolled diabetes (HbA1C higher than 6.5 percentage) 3.Participants with hypo or hyperthyroidism (TSH levels less than 0.5 and greater than 4.5 mIU per L), adrenal insufficiency, or uncontrolled asthma despite medication. 4.Participants with major depressive disorder, bipolar disorder, schizophrenia, dementia, or delusional disorders or individuals with insomnia. 5.Participants with anemia: Hemoglobin less than 13 g per dL for men, less than 12 g per dL for women. 6.Participants with any chronic medical condition. 7.History of malignant tumours within the past 5 years. 8.Participants who consume alcohol (greater than equal to 40 g per day of alcohol or women consuming greater than equal to 20 g per day of alcohol (based on WHO alcohol consumption criteria), smoke (( greater than 20 cigarettes per day), or use any form of nicotine (including chewing tobacco, e-cigarettes, or nicotine replacement products), consume greater than 400 mg caffeine per day (that is greater than 4 cups brewed coffee or equivalent from tea, energy drinks, soft drinks, or supplements). 9.Participants with sedentary lifestyles are not able or not advised to undergo the resistance training as per protocol. 10.Any clinically relevant macro or micronutrient deficiency as per the investigators discretion. 11.Any known cardiovascular or metabolic disease. 12.Pregnant women, lactating women, women of childbearing potential not following adequate contraceptive measures, and women who were found positive for a urine pregnancy test. 13.Participants who are currently taking any herbal, nutraceutical supplements, or those who are unwilling or unable to refrain from consuming nitrate-rich foods (such as beetroot, spinach, or similar sources) during the study period. 14.Those unable to perform exercise, such as treadmill tests. 15.Those engaged in excessive physical labour in their occupation or who are professional athletes. 16.Those with allergies or side effects to investigational product ingredients. 17.Those who have participated in another clinical trial within the past 3 months. 18.Any other condition which proves the participant unfit for the study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Evaluate the impact of red and green spinach extract (SpinoleRG ) capsules on physical performance measures, cardiorespiratory health and endurance, anthropometric measurements, hypertrophy, and body composition over 12 weeks in physically active individuals. 2.Assess the efficacy of red and green spinach extract (SpinoleRGTM) capsules on changes in muscle strength, biochemical markers, recovery from exercise and laboratory investigations in physically active individuals. Timepoint: from baseline to end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events profile 2. Compliance and tolerability of the investigational product.Timepoint: from baseline to end of the study. | — |
Countries
India
Contacts
Public ContactDr Siddharth J Modi
Viridis Biopharma Pvt. Ltd.
Outcome results
None listed