Improving Body CompositionNSCMNCT07038135
Formulation, Phytochemical Characterization, and Clinical Assessment of a Novel Natural Supplement Targeting Body Composition in Physically Active Individuals
A study testing Novel Natural Supplement (NNS) in people with Improving Body Composition and Novel Natural Gym Nutrient Formulation, run by Sulaimani Polytechnic University at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Improving Body Composition, Novel Natural Gym Nutrient Formulation, Increase Muscle Mass
- What is being tested?
- Novel Natural Supplement (NNS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteIraq
- Study dates
- 17 Jun 2024to 4 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- - 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 locations and contacts
1 site in 1 country.
About this study
Official title: Formulation, Phytochemical Characterization, and Clinical Assessment of a Novel Natural Supplement Targeting Body Composition in Physically Active Individuals: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
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.
Read the 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
- Conditions
- Improving Body Composition, Novel Natural Gym Nutrient Formulation, Increase Muscle Mass, Reduce Body Fat Percentage, Enhancing Metabolic Health and Athletic Performance
- Being tested
- Novel Natural Supplement (NNS), Placebo
- Keywords
- Body composition, Muscle mass, Natural supplement, Herbal formulation, Randomized controlled trial, Placebo-controlled trial, Antioxidant capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Natural Supplement (NNS)Dietary supplement
Also called Experimental
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.
PlaceboDietary supplement
A placebo containing maltodextrin, microcrystalline cellulose, and beetroot powder, matched in appearance, flavor, and texture to the NNS. Administered daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Novel Natural Supplement (NNS); Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks (post-intervention)
Secondary outcomes (2)
Change in body fat percentage (%)
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.
Measured: 8 weeks (post-intervention)
Change in Body Mass Index (BMI) (kg/m²)
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.
Measured: 8 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start17 Jun 2024
- Primary completion4 Jan 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Improving Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sulaimani Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tablo Azad Hama salih, Sulaimani Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038135
- Sponsor's protocol ID
- SPU2025NUTR01
- Acronym
- NSCM
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36778595Nederveen 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.
PubMed 37686725
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formulation, Phytochemical Characterization, and Clinical Assessment of a Novel Natural Supplement Targeting Body Composition in Physically Active Individuals: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07038135
- Acronym / sponsor ID
- NSCM / SPU2025NUTR01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Sulaimani Polytechnic UniversityUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 4 Jan 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Novel Natural Supplement (NNS) Group | Experimental | Dietary Supplement: Novel Natural Supplement (NNS), Dietary Supplement: PlaceboParticipants 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. |
| Placebo Group | Placebo comparator | Dietary Supplement: Novel Natural Supplement (NNS), Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Current smoker
- Use of assistive walking devices
- Chronic use of analgesic or anti-inflammatory medications
- Diagnosed with any of the following conditions:
- - Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Natural Supplement (NNS)Also: ExperimentalMulti-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 supplement | Novel Natural Supplement (NNS) Group, Placebo Group |
| PlaceboA placebo containing maltodextrin, microcrystalline cellulose, and beetroot powder, matched in appearance, flavor, and texture to the NNS. Administered daily for 8 weeks. | Dietary supplement | Novel Natural Supplement (NNS) Group, Placebo Group |
Primary outcome
Change in muscle mass (kg or %)
Time frame: 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.
2 secondary outcomes
Change in body fat percentage (%)
Time frame: 8 weeks (post-intervention)
Change in Body Mass Index (BMI) (kg/m²)
Time frame: 8 weeks (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Results publication: PubMed 36778595Nehmi-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.
- Results publication: PubMed 37686725Nederveen 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Natural Supplement (NNS) in people with Improving Body Composition and Novel Natural Gym Nutrient Formulation, run by Sulaimani Polytechnic University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle mass (kg or %) (time frame: 8 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07038135, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.