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

NCT07038135 | Completed DMC

• 1 other identifier: SPU2025NUTR01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Body composition; Muscle mass; Natural supplement; Herbal formulation; Randomized controlled trial; Placebo-controlled trial; Antioxidant capacity

Outcome Measures

Primary Outcomes (1)

• Change in muscle mass (kg or %)

  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.

  8 weeks (post-intervention)

Secondary Outcomes (2)

• Change in body fat percentage (%)

  8 weeks (post-intervention)

• Change in Body Mass Index (BMI) (kg/m²)

  8 weeks (post-intervention)

Other Outcomes (1)

• Change in weight (kg)

  8 weeks (post-intervention)

Study Arms (2)

Novel Natural Supplement (NNS) Group

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.

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

Placebo Group

PLACEBO COMPARATOR

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.

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

Interventions

Novel Natural Supplement (NNS) DIETARY_SUPPLEMENT

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.

Also known as: Experimental

Novel Natural Supplement (NNS) Group; Placebo Group

Placebo DIETARY_SUPPLEMENT

A placebo containing maltodextrin, microcrystalline cellulose, and beetroot powder, matched in appearance, flavor, and texture to the NNS. Administered daily for 8 weeks.

Novel Natural Supplement (NNS) Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sulaimany Polytechnic university: lead

Study Sites (1)

Halabja Technical college

Sulaymaniyah, Halabja Governorate, 00964, Iraq

Location

Related Publications (2)

• Nehmi-Filho V, Santamarina AB, de Freitas JA, Trarbach EB, de Oliveira DR, Palace-Berl F, de Souza E, de Miranda DA, Escamilla-Garcia A, Otoch JP, Pessoa AFM. Novel nutraceutical supplements with yeast beta-glucan, prebiotics, minerals, and Silybum marianum (silymarin) ameliorate obesity-related metabolic and clinical parameters: A double-blind randomized trial. Front Endocrinol (Lausanne). 2023 Jan 27;13:1089938. doi: 10.3389/fendo.2022.1089938. eCollection 2022.

  PMID: 36778595 BACKGROUND

• Nederveen JP, Mastrolonardo AJ, Xhuti D, Di Carlo A, Manta K, Fuda MR, Tarnopolsky MA. Novel Multi-Ingredient Supplement Facilitates Weight Loss and Improves Body Composition in Overweight and Obese Individuals: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2023 Aug 23;15(17):3693. doi: 10.3390/nu15173693.

  PMID: 37686725 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: June 17, 2024
• Primary Completion: January 4, 2025
• Study Completion: April 4, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

IR (1)