Randomized, Double-Blind, Four-Arm Pilot Study on the Effects of BRAND'S Chicken Essence and FlexC-II® on Joint, Bone, and Muscle Functions
Bibliographic record
Abstract
Abstract BackgroundKnee osteoarthritis (OA) is a leading cause of disability among elderly individuals. Medical and surgical treatments are expensive and have side effects. The current study aimed to investigate the efficacy and safety of FlexC-II ® , a type II collagen hydrolysate, and BRAND'S Essence of Chicken with FlexC-II ® (BEC-FlexC-II ® ) on joint, muscle, and bone functions among elderly adults with OA.MethodsPatients (n = 160) with grade 1–3 knee OA based on the Kellgren–Lawrence classification system, joint pain for ≥3 months, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score of >6 were considered eligible in this study. The participants were randomized into four groups (BEC-FlexC-II ® , FlexC-II ® , glucosamine hydrochloride [HCl], and placebo) and were instructed to perform resistance training for 24 weeks. The outcomes included WOMAC score, visual analogue scale (VAS) score, hand grip strength, fat-free mass (FFM), bone mass, and 36-Item Short-form Survey score. ResultsThe WOMAC scores of all groups improved after 24 weeks. However, the results did not significantly differ. Meanwhile, there was a remarkable difference in the VAS score between groups (P = 0.039). The FlexC-II ® group had a greater reduction in pain than the placebo group (mean ± standard error: −1.3 ± 0.45, P = 0.021). In the FlexC-II ® group, the VAS score significantly reduced by 0.9 ± 1.89 (P = 0.034) after 14 days. In the adjusted analyses, the BEC-FlexC-II ® group had a significantly higher FFM than the glucosamine HCl (P = 0.02) and placebo (P = 0.017) groups and hand grip strength than the glucosamine HCl group (P = 0.002). Further, on the basis of a subgroup analysis, participants with poor training compliance in the BEC-FlexC-II ® group had a significantly higher left hip bone mass than those in the placebo (P = 0.01) and glucosamine HCl (P = 0.049) groups.ConclusionsFlexC-II ® relieves OA-associated pain within 14 days, and BEC-FlexC-II ® increases muscle mass and strength after 24 weeks. Thus, BEC-Flex-CII ® is a promising novel, holistic supplement that can improve mobility by promoting joint, muscle, and bone functions among elderly individuals. However, full-scale studies should be conducted in the future to validate these findings.Trial registrationThis clinical trial was retrospectively registered in ClinicalTrials.gov with the ID NCT04483024 on July 20, 2020. URL: https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0008FK4&selectaction=Edit&uid=U0004BM2&ts=2&cx=-5y1oh4
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.004 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".