OsteoarthritisNCT06021665
A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis
A study testing Fortetropin supplement and Cheese protein in people with Osteoarthritis, run by MYOS Corp at 1 site in United States.
Trial summary
This is a hybrid, double-blind, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will be randomized into either the intervention product or control group and will consume the test product or control daily. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Fortetropin supplement and Cheese protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2023to 1 Nov 2023
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 50-75 years of age
- Self-reporting osteoarthritis-like symptoms, experiencing 3 or more of the following symptoms: joint pain, inflammation, reduced mobility, joint swelling, and stiffness.
- Non-acute osteoarthritis, must have experienced symptoms for longer than 1 year.
- Generally healthy and don't live with any uncontrolled chronic disease
- Able to eat eggs (haven't been medically advised to avoid)
- Willing to stop eating eggs for the 12 week study
Who cannot join
- Anyone allergic or intolerant of eggs
- Anyone who has been advised to avoid eggs
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with known severe allergic reactions.
- Women who are pregnant, breastfeeding or attempting to become pregnant
- Unwilling to follow the study protocol.
Show all 17Show fewer
- Subjects currently enrolled in another clinical study
- Subjects having finished another clinical study within the last 4 weeks before inclusion
- Hypersensitivity, allergy, or intolerance against any compound of the test products (e. g. eggs)
- Recent implantation of a cardiac pacemaker or other active implants
- History of or present liver deficiency as defined by Quick < 70%
- History of hepatitis B, C, HIV
- Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
- Simultaneous study participation by members of the same household
- Any diet to lose body weight
- Eating disorders or vegan diet
- Present drug abuse or alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
This is a hybrid, double-blind, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will be randomized into either the intervention product or control group and will consume the test product or control daily. Participants will complete study-specific and validated questionnaires at Baseline, Week 6, and Week 12, as well as blood biomarker testing for a lipid panel and high-sensitivity C-reactive protein (hs-CRP) at Baseline and Week 12.
Osteoarthritis-like symptoms, such as joint pain, inflammation, and reduced mobility will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Two validated questionnaires, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Numeric Pain Rating Scale (NPRS) will also be completed at the questionnaire time points. A full lipid panel and hs-CRP measurement will be completed via in-person blood draws.
- Conditions
- Osteoarthritis
- Being tested
- Fortetropin supplement, Cheese protein
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortetropin supplementOther
Test Formulation: 10g serving Calories: 64.8g Carbohydrates: 0.45g Fats: 5.5g Protein: 3.38g
Cheese proteinOther
The cheese powder will act as the control product. Cheese powder has been chosen as it matches the macronutrient content of the test product, but without the active ingredient.
Control Formulation: 20g serving Calories: 93g Carbohydrates: 8g Fats: 5g Protein: 3g
| Study group | Role | What they receive |
|---|---|---|
| Fortetropin Group | Experimental | The Fortetropin group will receive a 20cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily. Receives: Other: Fortetropin supplement |
| Control Group | Placebo comparator | The control group will receive a 50cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily. The difference in scoop size is to allow for macronutrient matching of the intervention and control products. Receives: Other: Cheese protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12]
The WOMAC score is a widely used questionnaire-based assessment tool designed to evaluate the symptoms and functional limitations of individuals with osteoarthritis of the knee and hip joints. Patients are asked to rate their experience on a Likert scale, usually ranging from 0 to 4 or 5, where higher values indicate greater severity of symptoms or limitations.
Measured: 12 weeks
Change in Numeric Pain Rating Scale (NPRS). [Baseline to Week 12]
The NPRS scale is a commonly used tool for assessing and quantifying pain intensity. It's a self-report scale where individuals are asked to rate their pain on a numerical scale. The scale typically ranges from 0 to 10, with 0 representing "no pain" and 10 representing "worst pain imaginable."
Measured: 12 weeks
Changes in muscle mass perceived by participants. [Baseline to Week 12]
Survey-based assessment (0-5 scale) of participants perception of changes in muscle mass.
Measured: 12 weeks
Secondary outcomes (5)
Changes in total cholesterol. [Baseline to Week 12]
Participants will undergo blood tests to evaluate a range of parameters, including total cholesterol.
Measured: 12 weeks
Changes in blood triglycerides. [Baseline to Week 12]
Participants will undergo blood tests to evaluate a range of parameters, including triglycerides.
Measured: 12 weeks
Changes in High-Density Lipoprotein (HDL) cholesterol. [Baseline to Week 12]
Participants will undergo blood tests to evaluate a range of parameters, including HDL cholesterol.
Measured: 12 weeks
Changes in Low-Density Lipoprotein (LDL) cholesterol. [Baseline to Week 12]
Participants will undergo blood tests to evaluate a range of parameters, including LDL cholesterol.
Measured: 12 weeks
Changes in high-sensitivity C-reactive protein (hs-CRP). [Baseline to Week 12]
Participants will undergo blood tests to evaluate a range of parameters, including hs-CRP.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start19 Jun 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MYOS Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021665
- Sponsor's protocol ID
- 20320
- Status last verified
- Mar 2024
- First submitted
- 27 Aug 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis
- ClinicalTrials.gov ID
- NCT06021665
- Acronym / sponsor ID
- 20320
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MYOS CorpIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 1 Sep 2023 (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 is a hybrid, double-blind, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will be randomized into either the intervention product or control group and will consume the test product or control daily. Participants will complete study-specific and validated questionnaires at Baseline, Week 6, and Week 12, as well as blood biomarker testing for a lipid panel and high-sensitivity C-reactive protein (hs-CRP) at Baseline and Week 12.
Osteoarthritis-like symptoms, such as joint pain, inflammation, and reduced mobility will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Two validated questionnaires, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Numeric Pain Rating Scale (NPRS) will also be completed at the questionnaire time points. A full lipid panel and hs-CRP measurement will be completed via in-person blood draws.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two-group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Fortetropin Group | Experimental | Other: Fortetropin supplementThe Fortetropin group will receive a 20cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily. |
| Control Group | Placebo comparator | Other: Cheese proteinThe control group will receive a 50cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily. The difference in scoop size is to allow for macronutrient matching of the intervention and control products. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 50-75 years of age
- Self-reporting osteoarthritis-like symptoms, experiencing 3 or more of the following symptoms: joint pain, inflammation, reduced mobility, joint swelling, and stiffness.
- Non-acute osteoarthritis, must have experienced symptoms for longer than 1 year.
- Generally healthy and don't live with any uncontrolled chronic disease
- Able to eat eggs (haven't been medically advised to avoid)
Key exclusion criteria (17 listed)
- Anyone allergic or intolerant of eggs
- Anyone who has been advised to avoid eggs
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with known severe allergic reactions.
- Women who are pregnant, breastfeeding or attempting to become pregnant
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 |
|---|---|---|
| Fortetropin supplementTest Formulation: 10g serving Calories: 64.8g Carbohydrates: 0.45g Fats: 5.5g Protein: 3.38g | Other | Fortetropin Group |
| Cheese proteinThe cheese powder will act as the control product. Cheese powder has been chosen as it matches the macronutrient content of the test product, but without the active ingredient. Control Formulation: 20g serving Calories: 93g Carbohydrates: 8g Fats: 5g Protein: 3g | Other | Control Group |
Primary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12]
Time frame: 12 weeks
The WOMAC score is a widely used questionnaire-based assessment tool designed to evaluate the symptoms and functional limitations of individuals with osteoarthritis of the knee and hip joints. Patients are asked to rate their experience on a Likert scale, usually ranging from 0 to 4 or 5, where higher values indicate greater severity of symptoms or limitations.
Change in Numeric Pain Rating Scale (NPRS). [Baseline to Week 12]
Time frame: 12 weeks
The NPRS scale is a commonly used tool for assessing and quantifying pain intensity. It's a self-report scale where individuals are asked to rate their pain on a numerical scale. The scale typically ranges from 0 to 10, with 0 representing "no pain" and 10 representing "worst pain imaginable."
Changes in muscle mass perceived by participants. [Baseline to Week 12]
Time frame: 12 weeks
Survey-based assessment (0-5 scale) of participants perception of changes in muscle mass.
5 secondary outcomes
Changes in total cholesterol. [Baseline to Week 12]
Time frame: 12 weeks
Changes in blood triglycerides. [Baseline to Week 12]
Time frame: 12 weeks
Changes in High-Density Lipoprotein (HDL) cholesterol. [Baseline to Week 12]
Time frame: 12 weeks
Changes in Low-Density Lipoprotein (LDL) cholesterol. [Baseline to Week 12]
Time frame: 12 weeks
Changes in high-sensitivity C-reactive protein (hs-CRP). [Baseline to Week 12]
Time frame: 12 weeks
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 20 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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 Fortetropin supplement and Cheese protein in people with Osteoarthritis, run by MYOS Corp at 1 site in United States.
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 6 inclusion and 17 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 20 Mar 2024. 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 United States. 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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12] (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.