Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function (7DHA)

U

Universidad Católica San Antonio de Murcia

Status

Completed

Conditions

Joint Function Disorder

Treatments

Dietary Supplement: Omega-3 and/or botanical ingredient
Other: Control product consumption

Study type

Interventional

Funder types

Other

Identifiers

NCT05279573
UCAMCFE-00020

Details and patient eligibility

About

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.

Full description

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.

Enrollment

130 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

130 participants in 4 patient groups, including a placebo group

Combination of Omega-3 based product and botanical ingredient
Experimental group
Description:
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Treatment:
Dietary Supplement: Omega-3 and/or botanical ingredient
Omega-3 based product
Experimental group
Description:
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Treatment:
Dietary Supplement: Omega-3 and/or botanical ingredient
Botanical ingredient
Experimental group
Description:
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Treatment:
Dietary Supplement: Omega-3 and/or botanical ingredient
Control group
Placebo Comparator group
Description:
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Treatment:
Other: Control product consumption

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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