Formulation, Phytochemical Characterization, and Clinical Assessment of a Novel Natural Supplement Targeting Body Composition in Physically Active Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2025-04-04

Brief Summary

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This study aims to evaluate the efficacy of a novel natural gym nutrient formulation (NNS) in improving body composition in physically active individuals. The formulation consists of a multi-ingredient blend of natural ingredients including whey protein, pea protein, oats, sweet potato, flaxseed, chia seeds, spinach powder, green tea extract, and beetroot powder. These ingredients are carefully selected for their potential to enhance muscle mass, reduce body fat, and improve metabolic health.

The study follows a randomized, double-blind, placebo-controlled design where participants are randomly assigned to receive either the NNS or a placebo (PLA). Both the NNS and PLA are identical in appearance to maintain the blinding of both the participants and the investigators. The trial is conducted over 8 weeks, with daily supplementation and body composition assessments (muscle mass, fat percentage, body water content) being conducted at baseline and at the end of the intervention. The study also includes analysis of the formulation's chemical properties, antioxidant capacity, and bioactive compounds to validate its effectiveness.

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Detailed Description

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This randomized, double-blind, placebo-controlled clinical trial assessed the efficacy of a novel, multi-ingredient natural supplement (NNS) designed to improve body composition and metabolic health in endurance-trained individuals. The NNS formulation combines plant-based proteins, dietary fibers, polyphenols, and antioxidant-rich botanicals with the aim of enhancing lean mass, reducing body fat, and supporting cardiopulmonary function. The active ingredients include whey protein, pea protein, oats, sweet potato, flaxseed, chia seeds, spinach powder, cardamom, green tea extract, beetroot powder, and stevia.

Prior to clinical assessment, the formulation underwent detailed chemical characterization, including analysis of physicochemical properties (pH, acidity, °Brix), proximate composition (fat and protein content), mineral profile (via ICP-OES), fatty acid composition (via GC-FID), antioxidant capacity (DPPH and ABTS assays), and bioactive compound identification (GC-MS). The formulation demonstrated high protein content, a favorable fatty acid profile rich in omega-3s, potent antioxidant activity, and the presence of bioactive compounds with anti-inflammatory and muscle-supportive properties.

In the clinical phase, participants were randomly assigned to consume either the NNS or a placebo (matched in appearance, flavor, and texture) daily for 8 weeks. Blinding was maintained for participants, care providers, investigators, and outcome assessors. Body composition was assessed via bioelectrical impedance analysis, alongside measurements of oxygen saturation, heart rate, and serum metabolic markers. The study aimed to provide scientific validation for the role of natural, protein-rich, multi-ingredient supplements in promoting muscle accretion, reducing body weight and BMI, improving metabolic markers, and supporting cardiopulmonary health in physically active individuals

Conditions

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Improving Body Composition Novel Natural Gym Nutrient Formulation Increase Muscle Mass Reduce Body Fat Percentage Enhancing Metabolic Health and Athletic Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a parallel study design, where participants are randomly assigned to one of two groups: the treatment group receiving the natural supplement (NNS) and the control group receiving a placebo. Both groups are followed concurrently for the duration of the 8-week study period to assess the intervention's impact on body composition, including muscle mass and fat percentage.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

In this double-blind, placebo-controlled study, the following parties are masked:

Participants: They are unaware of whether they are receiving the Novel Natural Supplement (NNS) or the placebo, ensuring unbiased reporting of results.

Care Providers: The individuals administering the treatment or placebo are blinded to prevent any bias in delivering the intervention.

Investigators: The researchers responsible for data collection and analysis do not know which participants are in the treatment or placebo groups, reducing bias in assessments and interpretation.

Outcomes Assessors: Those measuring body composition and other health parameters are blinded to participant group assignments to ensure unbiased measurement and analysis.

This rigorous blinding process helps ensure that the outcomes are not influenced by expectations or biases from any party involved in the study.

Study Groups

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Novel Natural Supplement (NNS) Group

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 Type EXPERIMENTAL