Clinical trial NCT06021665: A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis
Official title: A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: MYOS Corp
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group, randomized controlled trial
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in Numeric Pain Rating Scale (NPRS). [Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in muscle mass perceived by participants. [Baseline to Week 12]
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in total cholesterol. [Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in blood triglycerides. [Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in High-Density Lipoprotein (HDL) cholesterol. [Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in Low-Density Lipoprotein (LDL) cholesterol. [Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in high-sensitivity C-reactive protein (hs-CRP). [Baseline to Week 12]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: