Study on "Essen Plant Protein" - A nutritional powdered supplement for active adults (exercisers, gym goers) for protein supplementation. The Protein is vegan - plant based protein only.

An Open Label, Prospective, Randomised, Non-Comparative, Two Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Essen Plant Protein ? of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in Physically Active Adults

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/043981

Enrollment

Registered

2022-07-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None listed

Interventions

Intervention1: Essen Plant Protein : Unflavoured: Route of Administration : Oral Formulation : Plant Based Powered Nutritional Formulation Dose : 29g (3 heaped scoops) in 500ml of water Dosage : OD fo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically healthy Physically Active Adults between the ages of 40 and 65 years (both ages and all genders inclusive). 2. Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving general health, strength and performance 3. Subjects who are not on rapid weight loss programs such as but not limited to keto, paleo, warrior, caveman diets. Intermittent fasting is permitted. 4. Subjects who have scored 12-14 in Mini Nutritional Assessment MNA-SF Questionnaire at the time of screening. 5. Subjects who are physically active i.e walk/cycle/perform other cardio activities for 30 minutes 3 times a week). 6. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period. 7. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

Exclusion criteria

Exclusion criteria: 1. Subjects with known hypersensitivity to the ingredients of the investigational product 2. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study. 3. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 4. Subjects on remission from cancer of any type less than 5 years at the time of screening 5. Subjects who are planning a pregnancy and/or currently breastfeeding. 6. Subjects who have participated in a clinical study less than 1 month before screening 7. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 8. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 9. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

Design outcomes

Primary

Measure	Time frame
1. Stair Climbing Test : Increase of 10% from baseline 2. 30 Second Chair Stand Test : Increase of 10% from baseline 3. Borg Rating of Perceived Exertion : Decrease of 3 scores from baseline 4. Hand Grip Strength using Dynamometer : Increase of 10% from baseline Timepoint: 1. Stair Climbing Test : Day 1, Day 45, Day 90 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90	—

Measure

Time frame

1. Stair Climbing Test : Increase of 10% from baseline 2. 30 Second Chair Stand Test : Increase of 10% from baseline 3. Borg Rating of Perceived Exertion : Decrease of 3 scores from baseline 4. Hand Grip Strength using Dynamometer : Increase of 10% from baseline Timepoint: 1. Stair Climbing Test : Day 1, Day 45, Day 90 2. 30 Second Chair Stand Test : Day 1, Day 45, Day 90 3. Borg Rating of Perceived Exertion : Day 1, Day 45, Day 90 4. Hand Grip Strength using Dynamometer : Day 1, Day 45, Day 90

—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactDr VT Sriraam

Aurous HealthCare R&D India Pvt. Ltd.

md@auroushealthcare.com9840909155

Outcome results