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Analysis of Effectiveness of a Supplement Combining Harpagophytum procumbens, Zingiber officinale and Bixa orellana in Healthy Recreational Runners with Self-Reported Knee Pain: A Pilot, Randomized, Triple-Blind, Placebo-Controlled Trial.

ABSTRACT: Recreational running (RR) is becoming a popular way to increase physical activity for improving health, together with a higher incidence of knee injuries. The aim was to analyze the effect of a four-week supplementation with a mixture of Harpagophytum procumbens, Zingiber officinale and Bixa orellana on males, middle-aged, RR with an undiagnosed knee discomfort. A randomized triple-blind placebo-control trial was conducted among male RR aged 40-60 years suffering from self-declared knee discomfort after training. Participants were assigned to supplementation (2 g/day in 6 doses; n = 13; intervention group (IG)) or matched placebo (n = 15; control group (CG)) for 4 weeks. At pre- and post-intervention, assessment of routine blood biomarkers, body composition, running biomechanics and body temperature was performed using standardized procedures. Machine learning (ML) techniques were used to classify whether subjects belonged to IG or CG. ML model was able to correctly classify individuals as IG or CG with a median accuracy of 0.857. Leg fat mass decreased significantly (p = 0.037) and a deeper reduction in knee thermograms was observed in IG (p < 0.05). Safety evaluation revealed no significant differences in the rest of parameters studied. Subjects belonging to IG or CG are clearly differentiated, pointing into an effect of the supplement of ameliorating inflammation.

SUBMITTER: Gonzalez-Gross M

PROVIDER: S-EPMC8196851 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThere is an increasing interest in the use of eccentric muscle exercise to improve physical condition, especially with regards to its health-related benefits. However, it is known that unaccustomed eccentric exercise causes muscle damage and delayed pain, commonly defined as "delayed onset muscle soreness" (DOMS). The efficacy of herbal preparations in subjects suffering from DOMS has been reported in a few previous studies with small or moderate outcome measures related to muscle recovery. The present study aimed to evaluate the effects of a polyherbal mixture containing whole Zingiber officinale Roscoe and Bixa orellana L., powders called ReWin(d), in young male athletes suffering from DOMS induced by a 1 h session of plyometric exercises.MethodsThirty-three young male athletes participated in this randomized, Triple-blind, placebo-controlled trial: 17 of them assigned to the ReWin(d) group and 16 of them to the placebo group. Creatine kinase (CK) was measured as a muscle damage marker, pain was assessed using the Visual Analog Scale (VAS), muscle performance was measured through half-squat exercise (HS) monitored with an accelerometer (Encoder), and heart rate variability (HRV) was monitored for 5 min with the subjects in the supine position. All determinations were performed before and after the eccentric session and 24, 48, and 72 h after the session.ResultsThe eccentric exercise session caused an increase in CK at 24 and 48 h after exercise intervention in both groups (p < 0.001). There was no interaction between groups regarding muscle damage. The pain increased after the training session in both groups (p < 0.001), and a significant interaction was observed between groups at 48 h after exercise (p = 0.004). Lower limb muscular power showed a significant interaction between groups 24 h after exercise (p = 0.049); the placebo group showed a reduction in muscle power compared to the ReWin(d) group. The LF/HF ratio decreased significantly at 72 h after exercise in the herbal group but not in the placebo group.ConclusionThe herbal supplement maintained the maximum power of the lower limbs and attenuated muscle pain.Clinical trial registrationwww.ClinicalTrials.gov, identifier NCT03961022.

Project description:BACKGROUND:A variety of medicinal products prepared from secondary tubers of Harpagophytum procumbens subsp. procumbens (Burch.) DC.ex Meisn. (Devil's Claw) and H. zeyheri are marketed in Africa, Europe, the United States, South America and elsewhere, where they are used for inflammatory and musculoskeletal conditions such as arthritis, lower back pain, rheumatism and neuralgia, etc. While clinical studies conducted over the last twenty years support the general safety of such products, infrequent gastrointestinal disturbances (diarrhea, nausea, vomiting, abdominal pain), headache, vertigo and hypersensitivity (allergic) reactions (rash, hives and face swelling) have been documented. Sex-related differences occur in the health conditions for which Devil's Claw products are used, so it is likely that usage is similarly sex-related and so might be side effects and potential toxicities. However toxicologic studies of Devil's Claw products have been conducted primarily with male animals. To address this deficit, we report toxicological studies in female and male rats of several H. procumbens (HP) aqueous-alcohol extracts chemically analyzed by UPLC-MS. METHODS:Female and male Sprague Dawley rats were studied for one and three months in groups differing by consumption of diets without and with HP extracts at a 7-10-fold human equivalent dose (HED). Sera were analyzed for blood chemistry, and heart, liver, lung, kidney, stomach, and small and large intestine tissues were examined for histopathology. Treatment group differences for blood chemistry were analyzed by ANOVA with Dunnett's test and significant group differences for endpoints with marginal distributional properties were verified using the Kruskal-Wallis test. Group differences for histopathology were tested using Chi Square analysis. RESULTS:Significant group by sex-related differences in blood chemistry were detected in both studies. Additionally, several sex-related differences occurred between the studies. However, significant histopathology effects associated with the consumption of the extracts were not detected. CONCLUSION:Toxicologic analysis of Devil's Claw extracts cause significant sex-related effects in blood chemistry. However, in our judgement, none of the observed effects suggest serious toxicity at these doses and durations. Subsequent toxicologic and clinical studies of H. procumbens and other medicines with similar properties should explore in greater detail the basis and consequences of potential sex-related effects.

Dataset Information

Analysis of Effectiveness of a Supplement Combining Harpagophytum procumbens, Zingiber officinale and Bixa orellana in Healthy Recreational Runners with Self-Reported Knee Pain: A Pilot, Randomized, Triple-Blind, Placebo-Controlled Trial.

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