Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortetropin supplement | Other | Test Formulation: 10g serving Calories: 64.8g Carbohydrates: 0.45g Fats: 5.5g Protein: 3.38g |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in total cholesterol. [Baseline to Week 12] | Participants will undergo blood tests to evaluate a range of parameters, including total cholesterol. | 12 weeks |
| Changes in blood triglycerides. [Baseline to Week 12] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Two-group, randomized controlled trial
Not provided
Not provided
Both groups and the study coordinators will be blinded to the allocation.
| 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 |
|
Participants will undergo blood tests to evaluate a range of parameters, including triglycerides.
| 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |