Clinical Trial of plant protein source in comparison with whey protein concentrate(80%)

Randomized controlled trial to evaluate efficacy and safety of plant protein source in comparison with whey protein concentrate (80%) in improving muscle mass, strength and stamina in male subjects with active lifestyle. - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044843

Enrollment

Registered

2022-08-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

None listed

Interventions

Intervention1: AS-IT-IS Atom Plant Protein complex: 30gms (1 scoop at a time) mixed with 200ml water daily twice a day for 8 weeks. Control Intervention1: AS-IT-IS Whey Protein Concentrate 80%: 30gms

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male subjects 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. Willing to undergo full body resistance training three times per week (3 exercises, 3 sets of 8-12 repetitions per set). 5. Willing to provide consent. 6.Willing for follow up.

Exclusion criteria

Exclusion criteria: 1. Subjects with any acute illness requiring immediate medical care. 2.Subjects with any chronic medical condition. 3. Subjects with sedentary lifestyle 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 subject unfit for the study participation. 6. Any known cardiovascular or metabolic disease.

Design outcomes

Primary

Measure	Time frame
1.Changes in Body Weight, BMI and hip, waist and chest circumferences 2.Muscle strength (measured by leg extension and bench press through one repetition maximum (1 RM)) 3.Cardiorespiratory endurance (maximal oxygen uptake (VO2 max) Timepoint: Screening, Baseline, Day 30, Day 60	—

Secondary

Measure	Time frame
1.Changes in % fat and % skeletal muscle by impendence test Timepoint: Screening, Baseline,Day 30, Day 60	—

Countries

India

Contacts

Public ContactMr Arvind Jain

Medizen Labs Pvt. Ltd.

info@zenithnutrition.com9945806347

Outcome results