Enhancing Metabolic Health and Athletic Performance, Improving Body Composition, Increase Muscle Mass, Novel Natural Gym Nutrient Formulation, Reduce Body Fat Percentage
Conditions
Keywords
Body composition, Muscle mass, Natural supplement, Herbal formulation, Randomized controlled trial, Placebo-controlled trial, Antioxidant capacity
Brief summary
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.
Detailed 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
Interventions
DIETARY_SUPPLEMENTNovel Natural Supplement (NNS)
Multi-ingredient formula including whey protein, pea protein, oats, sweet potato, flaxseed, chia seeds, spinach powder, cardamom, green tea extract, beetroot powder, and stevia. Administered daily for 8 weeks.
DIETARY_SUPPLEMENTPlacebo
A placebo containing maltodextrin, microcrystalline cellulose, and beetroot powder, matched in appearance, flavor, and texture to the NNS. Administered daily for 8 weeks.
Sponsors
Sulaimany Polytechnic university
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle mass (kg or %) | 8 weeks (post-intervention) | The primary objective of this study is to evaluate the effect of the Novel Natural Supplement (NNS) on muscle mass in physically active individuals. Muscle mass will be assessed using bioelectrical impedance analysis (BIA) at baseline and at the end of the 8-week intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body fat percentage (%) | 8 weeks (post-intervention) | The secondary outcome is to assess the effect of NNS on body fat percentage. Body fat will be measured using bioelectrical impedance analysis (BIA) at baseline and after 8 weeks of supplementation. |
| Change in Body Mass Index (BMI) (kg/m²) | 8 weeks (post-intervention) | BMI will be calculated using participants' weight and height at baseline and after 8 weeks of supplementation. This measure will help assess changes in body composition (i.e., weight and fat mass) relative to height and can provide additional insights into the overall effect of the intervention on participants' physical health. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in weight (kg) | 8 weeks (post-intervention) | he effect of the Novel Natural Supplement (NNS) on body weight will be assessed by measuring the participants' weight at baseline and after 8 weeks of supplementation. This outcome will help evaluate whether the supplement contributes to weight loss or gain, depending on changes in muscle mass and fat percentage. |
Countries
Iraq
Outcome results
None listed