Trial | NCT05279573  Report issue

Title

Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
Randomized Controlled Intervention Study to Analyze the Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    130
Randomized, controlled, double-blind intervention study of four parallel branches depending on the product consumed, to analyze the efficacy of an Omega-3 based product on the mobility and functionality of the evaluated joint.
The duration of the study will be 60 days (8 weeks). Each day they will have to consume the product under investigation. Subjects who meet the selection criteria will be randomized into each of the study groups (A, B, C o D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary regarding pain and concomitant medication.

They will make a total of two visits to the research laboratory and will perform the tests pre-established in the protocol. In addition, a follow-up telephone call will be made after 30 days of consume. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.
Study Started
Feb 14
2022
Primary Completion
Nov 29
2022
Study Completion
Dec 23
2022
Last Update
Dec 28
2022

Dietary Supplement Omega-3 and/or botanical ingredient

Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Other Control product consumption

Product with identical characteristics to the experimental product. Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Combination of Omega-3 based product and botanical ingredient Experimental

Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Omega-3 based product Experimental

Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Botanical ingredient Experimental

Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Control group Placebo Comparator

Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.

Criteria 

Inclusion Criteria:

Healthy adults (age: 40-75 YO).
Subjects must have persistent knee pain with a baseline VAS pain assessment score of at least 30 mm.
Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.

Exclusion Criteria:

Serious or terminal illnesses.
Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.
Subjects who are currently consuming or have consumed in the last two months any Omega-3 based supplement and/or supplement based on the botanical ingredient under investigation.
Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
Subjects with a body mass index above 32.
Subjects with known allergy to any of the study components.
Pregnant or lactating women.
Inability to understand informed consent.
No Results Posted