Completed

NSCMNatural Supplement for Body Composition Improvement in Physically Active Individuals

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Study Aim

This study examines if the Novel Natural Supplement (NNS) can enhance muscle mass in physically active people. Over 8 weeks, muscle mass will be measured using bioelectrical impedance analysis to see how the supplement affects it.

What is being tested

Novel Natural Supplement (NNS)

+ Placebo

Dietary Supplement
Who is being recruted

From 18 to 45 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: June 2024
See protocol details

Summary

Principal SponsorSulaimany Polytechnic university
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 17, 2024

Actual date on which the first participant was enrolled.

This clinical trial explores the effectiveness of a new natural supplement in improving body composition and metabolic health for endurance-trained individuals. The supplement includes a mix of plant-based proteins, fibers, and antioxidants aimed at increasing lean muscle, reducing body fat, and supporting heart and lung health. The ingredients in this supplement are whey protein, pea protein, oats, sweet potato, flaxseed, chia seeds, spinach powder, cardamom, green tea extract, beetroot powder, and stevia. This study is important because it seeks to scientifically validate whether such a multi-ingredient supplement can offer tangible health benefits for active people looking to enhance their physical fitness and metabolic functions. Participants in the study are randomly divided into two groups: one receiving the natural supplement and the other a placebo, with neither the participants nor the researchers knowing who is in which group. The supplement or placebo is taken daily for eight weeks. Researchers measure body composition using a technique that analyzes body fat and lean mass, alongside checking oxygen levels, heart rate, and various blood markers related to metabolism. These assessments help determine the supplement's impact on muscle growth, weight loss, and overall metabolic health. By evaluating these outcomes, the study aims to provide a clearer picture of the potential benefits of natural, protein-rich supplements for physically active individuals.

Official TitleFormulation, Phytochemical Characterization, and Clinical Assessment of a Novel Natural Supplement Targeting Body Composition in Physically Active Individuals: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
NCT07038135
Principal SponsorSulaimany Polytechnic university
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

65 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Ability to provide written informed consent prior to participation

Males and females aged 18 to 45 years

Body Mass Index (BMI) between 18.5 and 29.5 kg/m²

Engaging in endurance training at least 3 times per week

12 exclusion criteria prevent from participating
Current smoker

Use of assistive walking devices

Chronic use of analgesic or anti-inflammatory medications

Diagnosed with any of the following conditions:

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants in this arm received a daily 30-gram dose of the Novel Natural Supplement (NNS), a multi-ingredient formula containing whey protein, pea protein, oats, sweet potato, flaxseed, chia seeds, spinach powder, cardamom, green tea extract, beetroot powder, and stevia. The intervention lasted for 8 weeks to assess its effect on body composition and metabolic health.

Group II

Placebo
Participants in this arm received a daily 30-gram dose of a placebo consisting of maltodextrin, microcrystalline cellulose, and beetroot powder, matched in appearance, flavor, and texture to the NNS. The intervention lasted for 8 weeks to serve as a control for the trial.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Halabja Technical college

Sulaymaniyah, IraqOpen Halabja Technical college in Google Maps
CompletedOne Study Center