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.

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

Inclusion Criteria:

• 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
• Ability to provide written informed consent prior to participation

Exclusion Criteria:

• Current smoker
• Use of assistive walking devices
• Chronic use of analgesic or anti-inflammatory medications
• Diagnosed with any of the following conditions:
• - Diabetes mellitus
• - Cardiovascular disease (including recent myocardial infarction or hypertension requiring more than two medications)
• - Congestive heart failure
• - Renal disease
• - Previous stroke
• Active musculoskeletal injury and/or severe osteoarthritis
• Significant weight change (more than ±4 kg) in the 8 weeks prior to the study
• Unable or unwilling to comply with study requirements

The individual participant data (IPD) to be shared will include de-identified data on body composition (muscle mass, fat percentage, body water content), weight, BMI, and blood glucose levels from participants who have completed the 8-week study. The data will be shared in a secure, anonymized format and will only be available to qualified researchers after study completion. Access will be granted through a formal data request process, ensuring privacy and compliance with ethical standards. All data will be stored and shared through a secure data repository.

The individual participant data (IPD) and supporting information (such as study protocol, statistical analysis plan, informed consent form, and clinical study report) will be made available 6 months after the completion of data collection, ensuring all study results are finalized and analyzed. The data will remain accessible for a period of 5 years from the date of publication or final analysis to allow for secondary analyses by qualified researchers.

The IPD and supporting information will be accessible to qualified researchers affiliated with academic institutions or research organizations, provided they submit a formal data request. Access will be granted to de-identified data related to body composition, weight, BMI, and other clinical measures as outlined in the study protocol. Researchers will be able to access the data via a secure data-sharing platform, and access will be granted only after ethical approval or a data-sharing agreement is in place to ensure compliance with privacy regulations.

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.