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

A clinical study to evaluate the impact of red and green spinach extract on performance, strength, stamina, and reducing muscle breakdown as well as promoting muscle synthesis in physically active individuals. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069665

Enrollment

Registered

2024-06-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Red and green spinach extract capsules: Two 500 mg capsules (Each containing 250 mg of red spinach extract and 250 mg of green spinach extract) in sequence 30-60 minutes prior to exerci

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. 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. Timepoint: Baseline, week 4 and week 8	—

Measure

Time frame

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. 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. Timepoint: Baseline, week 4 and week 8

—

Secondary

Measure	Time frame
1.Adverse events profile. 2.Compliance and tolerability of the investigational product.Timepoint: Baseline, week 4 and week 8	—

Countries

India

Contacts

Public ContactMr Anirudh Mehta

Phytoveda Pvt. Ltd

adme@phytoveda.in9820031562

Outcome results