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 machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".