Back to resultsA Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fortetropin supplement
Cheese protein
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis
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
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fortetropin Group
Control Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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."
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.
Secondary Outcome Measures
Changes in total cholesterol. [Baseline to Week 12]
Participants will undergo blood tests to evaluate a range of parameters, including total cholesterol.
Changes in blood triglycerides. [Baseline to Week 12]
Participants will undergo blood tests to evaluate a range of parameters, including triglycerides.
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.
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.
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.
Full Information
NCT ID
NCT06021665
First Posted
August 27, 2023
Last Updated
August 27, 2023
Sponsor
MYOS Corp
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT06021665
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MYOS Corp
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-group, randomized controlled trial
Masking
ParticipantInvestigator
Masking Description
Both groups and the study coordinators will be blinded to the allocation.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fortetropin Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Fortetropin supplement
Intervention Description
Test Formulation: 10g serving Calories: 64.8g Carbohydrates: 0.45g Fats: 5.5g Protein: 3.38g
Intervention Type
Other
Intervention Name(s)
Cheese protein
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12]
Description
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.
Time Frame
12 weeks
Title
Change in Numeric Pain Rating Scale (NPRS). [Baseline to Week 12]
Description
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."
Time Frame
12 weeks
Title
Changes in muscle mass perceived by participants. [Baseline to Week 12]
Description
Survey-based assessment (0-5 scale) of participants perception of changes in muscle mass.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in total cholesterol. [Baseline to Week 12]
Description
Participants will undergo blood tests to evaluate a range of parameters, including total cholesterol.
Time Frame
12 weeks
Title
Changes in blood triglycerides. [Baseline to Week 12]
Description
Participants will undergo blood tests to evaluate a range of parameters, including triglycerides.
Time Frame
12 weeks
Title
Changes in High-Density Lipoprotein (HDL) cholesterol. [Baseline to Week 12]
Description
Participants will undergo blood tests to evaluate a range of parameters, including HDL cholesterol.
Time Frame
12 weeks
Title
Changes in Low-Density Lipoprotein (LDL) cholesterol. [Baseline to Week 12]
Description
Participants will undergo blood tests to evaluate a range of parameters, including LDL cholesterol.
Time Frame
12 weeks
Title
Changes in high-sensitivity C-reactive protein (hs-CRP). [Baseline to Week 12]
Description
Participants will undergo blood tests to evaluate a range of parameters, including hs-CRP.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis
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