Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy Adults

NCT06650670 | Terminated DMC

• 1 other identifier: C030
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to determine the efficacy of oral administration of a bioactive compound (EPP) in healthy individuals with mild knee joint discomfort.

Conditions

Knee Discomfort

Keywords

extract; bioactive compound

Outcome Measures

Primary Outcomes (1)

• KOOS test total score.

  Using of the KOOS (Knee Injury \& Osteoarthritis Outcomes) Questionnaire.

  12 weeks

Secondary Outcomes (6)

• KOOS Subscales score (pain, symptoms, daily activity, sport and quality of life).

  12 weeks

• VPS scale for knee pain (general and after physical tests performed at the visits).

  12 weeks

• Objective assessment of physical activity.

  12 weeks

• Range of motion of the knee joint.

  12 weeks

• Changes observed between baseline and final MRI.

  12 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

Control group that will receive two capsules with the maltodextrin per day during 12 weeks

Dietary Supplement: Dietary Supplement: Placebo

EPP group

EXPERIMENTAL

Experimental group that will receive two capsules with the bioactive compound per day during 12 weeks

Dietary Supplement: Dietary Supplement: EPP

Interventions

Dietary Supplement: Placebo DIETARY_SUPPLEMENT

Each participant will consume 2 capsules per day in one of the main meals without any restriction in the diet or in their life habits

Control group

Dietary Supplement: EPP DIETARY_SUPPLEMENT

Each participant will consume 2 capsules per day in one of the main meals without any restriction in the diet or in their life habits

EPP group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy participants (men and women) between 35 and 65 years of age with knee discomfort.
• Mild knee joint pain (visual analog scale between 3 and 6 cm).

You may not qualify if:

• People with clinical osteoarthritis or any other degenerative joint disease.
• Persons receiving treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, HA, diacerein) two weeks prior to screening.
• Persons receiving intra-articular injections in the knee joint in the 3 months prior to the study.

Sponsors & Collaborators

• Biosearch S.A.: lead
• Universidad de Granada: collaborator
• University Hospital Virgen de las Nieves: collaborator

Study Sites (1)

Universidad de Granada (Dpto. educación Física y Deportiva)

Granada, Spain

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jonatan Ruiz Ruiz, Dr.

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 15, 2023
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

ES (1)