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

Sulaimany Polytechnic university

Status: Completed

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

Treatments: Dietary Supplement: Novel Natural Supplement (NNS); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07038135

SPU2025NUTR01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 65 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Novel Natural Supplement (NNS) Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Novel Natural Supplement (NNS)

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Novel Natural Supplement (NNS)