A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis
NCT ID: NCT06021665
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2023-06-19
2023-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Fortetropin Group
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.
Fortetropin supplement
Test Formulation: 10g serving Calories: 64.8g Carbohydrates: 0.45g Fats: 5.5g Protein: 3.38g
Control Group
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
75 Years
ALL
Yes
Sponsors
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Citruslabs
INDUSTRY
MYOS Corp
INDUSTRY
Responsible Party
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Locations
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Citruslabs
Santa Monica, California, United States
Countries
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Other Identifiers
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20320
Identifier Type: -
Identifier Source: org_study_id
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