Collagen Peptide Supplementation and Lifelong Athletes

NCT05751005 | Completed

• 1 other identifier: STUDY00000044
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current research is to evaluate the effects of 6 and 9 months of Solugel® supplementation on joint mobility, comfort, performance, body composition and related biomarkers of joint and bone health in older life-long athletes and physically active people. Doses of zero, 10, and 20 g per day for 6 or 9 months will be administered to determine, if any, is most effective at improving the previously mentioned outcomes.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Joint Health

  Knee Injury and Osteoarthritis Outcome Score (KOOS). Scores are from 0 to 100, with a score of 100 being the best score, and a score of 0 being the lowest.

  9 months

Study Arms (2)

Collagen Supplementation 6 months

EXPERIMENTAL

Participants were randomized into one of three treatment groups for 6 months (Placebo, 10 g/d collagen peptides, or 20 g/d collagen peptides).

Dietary Supplement: Collagen Peptides vs. Placebo

Collagen Supplementation 9 months

EXPERIMENTAL

Participants were randomized into one of three treatment groups (Placebo, 10 g/d collagen peptides, or 20 g/d collagen peptides) for additional 3 months after successful completion of the 6 month time point (total of 9 months).

Dietary Supplement: Collagen Peptides vs. Placebo

Interventions

Collagen Peptides vs. Placebo DIETARY_SUPPLEMENT

Participants were randomized into one of three treatment groups.

Collagen Supplementation 6 months; Collagen Supplementation 9 months

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 40-65 year.
• Perform greater than 4 hours per week of planned physical activity for the last 15 years.
• Report having periodic but sustained joint and/or musculoskeletal pain.
• Live in or near Tallahassee, FL.

You may not qualify if:

• Currently consuming collagen supplements (a 4 week washout period from the excluding supplement may be performed for the participant to be included).
• Currently using prescription pain medications (and cannot discontinue use during enrollment).
• Cortisone shot within the past 30 days (30 day washout period required).
• Smoking.
• Diagnosis of arthritis in the joints of interest (knee, hip, or shoulder joint).
• Diagnosis of autoimmune disorder.
• Initiation of hormone replacement therapy within the past 12 months.
• Uncontrolled medicated hypertension.
• Diagnosed kidney dysfunction.
• Allergies to milk or animal products.
• Surgery within the past 12 months.

Sponsors & Collaborators

• Florida State University: lead
• Tessenderlo Group: collaborator

Study Sites (1)

Institute of Sports Science and Medicine, Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This was a double blind study, in which investigators were not unblinded until all primary data end points were statistically analyzed. One person who was not involved in the study maintained the key until investigators were ready to be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two different doses of collagen peptides versus placebo.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: March 2, 2023
• Study Start: November 29, 2018
• Primary Completion: May 28, 2020
• Study Completion: April 4, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)