Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05751005 |
| Other study ID # |
STUDY00000044 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 29, 2018 |
| Est. completion date |
April 4, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Florida State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
2.0 Objectives*
2.1 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 20g per day for 6 or 9 months will be administered to determine, if
any, is most effective at improving the previously mentioned outcomes
2.2 We hypothesize that Solugel® at 10g and 20g will be more effective than the placebo
supplement at all outcome measures. We also hypothesize that 20g will be more effective than
10g.
3.0 Background*
3.1 Very active individuals may describe joint discomfort as one negative aspect limiting
their healthy lifestyles. Indeed, competitive swimmers (Wanivenhaus et al. Sports Health.
2012; 4:246-51) and those who partake in significant outdoor activity report substantial
joint discomfort (Mranda et al. Osteoarthr Cartil. 2002; 10:623-30). This joint discomfort
may be related to osteoarthritis (OA), a degenerative joint disease, presenting with focal
and progressive loss of hyaline cartilage of joints with joint space narrowing. Current
treatment for OA and joint pain include injectable corticosteroids and non-steroidal
anti-inflammatory drugs. These modes of treatment are effective for reducing pain, however,
they are not without serious long-term adverse effects including joint infection, nerve
damage, possible tendon weakening, dyspepsia, ulcers, bleeding and other gastrointestinal
complications.
In addition, very active individuals often complain of musculoskeletal injuries. Indeed, more
than half of all sports injuries include sprains, ruptures, and damage to musculoskeletal
tissue. The integrity of collagen-rich extracellular matrix that surrounds tendon, ligaments,
and bone determines both the structure and function of these musculoskeletal tissues.
Nutritional interventions that strengthen these musculoskeletal tissues likely have a direct
effect on injury prevention and rehabilitation. Indeed, supplementation with 5g or 15g of
gelatin in subjects that performed high-intensity intermittent exercise bouts demonstrated
improved collagen synthesis. In young athletic subjects, supplementation with 5g bioactive
collagen peptides for 12 weeks demonstrated significant improvements in activity-related pain
intensity compared to a placebo. The timing of collagen peptide intake in relation to
improvements in functional outcomes is still not determined. Only one study to date has
examined the influence of post-exercise collagen peptides compared to a placebo. The outcomes
of this singular study demonstrated exceptional body composition improvements in elderly
sarcopenic men. The increase in fat-free mass (FFM) and decrease in fat mass (FM) for the
treatment group (FFM: +4.2±2.3 kg; FM: -5.4±3.1 kg) was significantly greater than the
placebo group (FFM: +2.9±1.8kg; FM: -3.5±2.2 kg)). These changes in only 12 weeks were so
pronounced that it warranted a letter to the editor by renowned protein researchers
questioning the likelihood of such changes. To date, there has been no follow-up study to
replicate these findings with regard to body composition.
Aging clearly exacerbates joint pain and worsens body composition resulting in less strength,
less power, and decrements in exercise performance: an investigation using collagen peptides
in life-long athletes over age 50 years is clearly warranted. Therefore, we aim to evaluate
the effects of 9-months of Solugel® supplementation on joint mobility, comfort, performance,
body composition and related biomarkers of health in older athletes.
4.0 Study Endpoints*
4.1 To determine the extent to which Solugel® can improve joint health as measured by a
modified-Knee Injury & Osteoarthritis Outcome Score (mKOOS), and/or global & modified-Western
Ontario and McMaster Universities Arthritis Index (WOMAC) subscales (discomfort, stiffness &
function). Secondary outcome measures will include visual analog scale (VAS) questionnaires
for overall/whole-body joint pain and changes in knee range of motion as assessed using a
goniometer. Tertiary outcomes will include measures of cartilage synthesis and degradation
(plasma IGF-1, P1NP, CTX, TGF-beta, MMPs), inflammation (plasma CRP, TNF-α), and bone
formation and resorption (serum b-ALP).
To identify the extent to which Solugel® can improve body composition as measured with BIA
and dual-energy x-ray absorptiometry (DXA) (fat mass, fat-free mass). In addition, bone
mineral density (BMD) will be assessed (whole body, lumbar spine (L1-4) and left and right
hip).
5.0 Study Intervention/Investigational Agent
5.1 Participants will be randomly assigned to one of three treatment groups: 1) placebo
(maltodextrin); 2) 5g Solugel® + half serving of placebo; or 3) 10g Solugel®. Supplements
will be consumed 2 times per day for 9 months. Compliance will be assessed at various time
points throughout the duration of the study. Measurements will be taken at baseline, 1 month,
3 months, 6 months, and 9 months.
6.0 Procedures Involved*
6.1 To avoid risk of infection and spread of COVID-19, all participants will be screened for
symptoms per the current CDC guidelines. PPE will be worn by all research personnel and
participants, and six feet distancing will always be maintained when possible. All
non-essential in person visits will also be moved to an online format. The facilities and
equipment will be disinfected prior to study visits, and participants will be given the form
HRP-502ic to update them on FSUs policies regarding mitigating the infection and spread of
COVID-19.
Testing measures will include: Medical history questionnaire and aerobic fitness level
(baseline only), anthropometrics, physical activity questionnaire (once per month), DXA scan,
BIA, three day food records, pain questionnaire (once per month), range of motion (once per
month), and blood sampling.
Over the span of the study, participants will be randomly assigned to receive one of the
following treatments to be consumed 2 times per day: (1) Isocaloric placebo control
(maltodextrin, PLA); (2) 5g Solugel® + half serving of PLA (LOW); (3) 10g Solugel® (HIGH).
The supplements will be provided in identical packages and consumed with water. One month of
the supplement will be provided at each visit. Compliance will be ensured via phone and email
contact. A self-reported side-effects form will be completed monthly.
Baseline (0 months) Participants will arrive to the laboratory and complete screening
questions, medical history questionnaires, physical activity questionnaires, pain
questionnaires, informed consent documents, anthropometrics, DXA scan for bone density as
well as body composition, BIA for TBW, three-day food records, range of motion testing, and
blood sampling (20 ml).
Month 1 Participants will arrive to the laboratory and perform anthropometrics, DXA scan for
body composition only, BIA for TBW, physical activity questionnaires, pain questionnaires,
3-day food records, and range of motion testing.
Months 2, 4, 5, 7, 8 Participants will arrive to the laboratory and perform pain
questionnaires, physical activity questionnaires, and range of motion testing.
Month 3 Participants will arrive to the laboratory and complete screening questions, medical
history questionnaires, physical activity questionnaires, pain questionnaires, informed
consent documents, anthropometrics, DXA scan body composition only, BIA for TBW, three-day
food records, range of motion testing, and blood sampling (20 ml).
Months 6 & 9 Participants will arrive to the laboratory and complete screening questions,
medical history questionnaires, physical activity questionnaires, pain questionnaires,
informed consent documents, anthropometrics, DXA scan for bone density as well as body
composition, BIA for TBW, three-day food records, range of motion testing, and blood sampling
(20 ml).
All measures are performed by trained study staff to monitor subjects for safety and to
minimize risks.
6.2 The risk of adverse events from consumption of the supplement beverage is extremely
minimal. Body composition and bone mineral density will be evaluated by DXA. This involves
low exposure to radiation (less than 5 mREMs per DXA scan). Therefore, subjects undergoing
the DXA scan can have a slightly increased cancer risk. By comparison, an x-ray of the spine
is 70 mREM, a mammogram is 45 mREM, and a round trip transcontinental plane flight is 6 mREM.
The risk of adverse events from the aerobic fitness test are minimal, blood draw may cause
infection, localized bruising and discomfort, but all measures will be conducted by qualified
personnel who will be present during all experimental trials to ensure proper procedures are
followed. The risk of injury during the tests will be minimized by careful review of my
medical history form, and no other assessments carry a risk of harm to participants.
6.3 Information obtained during the course of the study will remain confidential to the
extent required by law. Participant names will not appear on any of the results. No
individual responses will be reported in publication, only group responses. Confidentiality
will be maintained by the assignment of a code number for each subject in which all data
recorded will be based. The only record containing both the participant's name and code
number will be kept by the principal investigator, Dr. Michael Ormsbee, in a locked drawer in
his laboratory. All records will be destroyed after a minimum of five years.
7.0 Study Timelines*
7.1 Individual participant study duration is 6 or 9 months. The duration anticipated to
enroll all study subjects is two years, and the estimated date for the investigators to
complete this study is July, 2022.
