A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06021665
• Other study ID #: 20320
• Status: Completed
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: March 2024
• Source: MYOS Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Fortetropin supplement
Test Formulation: 10g serving Calories: 64.8g Carbohydrates: 0.45g Fats: 5.5g Protein: 3.38g
• Cheese protein
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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
MYOS Corp	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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."	12 weeks
Primary	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.	12 weeks
Secondary	Changes in total cholesterol. [Baseline to Week 12]	Participants will undergo blood tests to evaluate a range of parameters, including total cholesterol.	12 weeks
Secondary	Changes in blood triglycerides. [Baseline to Week 12]	Participants will undergo blood tests to evaluate a range of parameters, including triglycerides.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks