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

NCT06021665 | Completed

• 1 other identifier: 20320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Changes in total cholesterol. [Baseline to Week 12]

  12 weeks

• Changes in blood triglycerides. [Baseline to Week 12]

  12 weeks

• Changes in High-Density Lipoprotein (HDL) cholesterol. [Baseline to Week 12]

  12 weeks

• Changes in Low-Density Lipoprotein (LDL) cholesterol. [Baseline to Week 12]

  12 weeks

• Changes in high-sensitivity C-reactive protein (hs-CRP). [Baseline to Week 12]

  12 weeks

Study Arms (2)

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.

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.

Other: Cheese protein

Interventions

Fortetropin supplement OTHER

Test Formulation: 10g serving Calories: 64.8g Carbohydrates: 0.45g Fats: 5.5g Protein: 3.38g

Fortetropin Group

Cheese protein OTHER

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

Control Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• MYOS Corp: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both groups and the study coordinators will be blinded to the allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-group, randomized controlled trial

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: June 19, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (1)