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

Myos Corporation

Status: Completed

Conditions: Osteoarthritis

Treatments: Other: Fortetropin supplement; Other: Cheese protein

Study type: Interventional

Funder types: Industry

Identifiers

NCT06021665

20320

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Fortetropin Group

Experimental group

Description:

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.

Treatment:

Other: Fortetropin supplement

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Cheese protein