MedPath

The impact of red and green spinach extract on performance and strength in physically active individuals.

Phase 2
Registration Number
CTRI/2024/06/069665
Lead Sponsor
Phytoveda Pvt. Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Male and female participants aged between 18-40 years having BMI less than 35 kg/m2 2.Resting blood pressure averaging less than 140/90 mmHg 3.Not on any medication for cardiovascular and metabolic disorders 4.Engaged in regular resistance training (comprising of cardio and strength training) for at least 1 year and willing to continue the same during the study 5.Participants consuming whey protein and possess a sufficient level of knowledge regarding the importance of dietary and lifestyle factors relevant to the study, as determined by the investigator 6.Willing to provide consent and come for regular follow-up visits.

Exclusion Criteria

1.Participants with any acute illness requiring immediate medical care;

2.Participants with any chronic medical condition;

3.Participants with sedentary lifestyles are not able or not advised to undergo the resistance training as per protocol;

4.Any clinically relevant macro or micro-nutrient deficiency as per investigator discretion;

5.Any other condition which proves the participant unfit for the study participation;

6.Any known cardiovascular or metabolic disease;

7.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test;

8.Participants who are taking any herbal nutraceutical supplements except plant-based protein supplementation.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Evaluate the impact of red and green spinach extract on physical performance, subjective measures like exertion and muscle fatigue, and physical measures, cardiorespiratory health and endurance, anthropometric measurements, hypertrophy, and body composition over a 8-week in physically active individuals. <br/ ><br>2.Assess the efficacy of red and green spinach extract on changes in muscle strength, biochemical markers, recovery from exercise and laboratory investigations in physically active individuals. <br/ ><br>Timepoint: Baseline, week 4 and week 8
Secondary Outcome Measures
NameTimeMethod
1.Adverse events profile. <br/ ><br>2.Compliance and tolerability of the investigational product.Timepoint: Baseline, week 4 and week 8 <br/ ><br>
© Copyright 2025. All Rights Reserved by MedPath