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Efficacy of a topical herbal and mineral formulation (Dynamiclear) for the treatment of herpes simplex labialis in the community setting: study protocol for a randomised, double-blind placebo-controlled trial.
Armour, M, Semprini, A, Ee, C, MacCullagh, L, Shortt, N
BMJ open. 2020;(1):e031876
Abstract
INTRODUCTION Herpes simplex labialis (HSL) is a common infection that can cause painful lesions on the oral mucosa, commonly referred to as cold sores. Current biomedical treatments include topical aciclovir, which reduces the episode duration by an average of 0.5 days. This study will examine the efficacy and tolerability of an over-the-counter topical treatment, Dynamiclear in reducing duration and severity of HSL episodes. METHODS AND ANALYSIS This prospective, randomised, double-blind, placebo-controlled, multi-centre trial will recruit a minimum of 292 adult participants across Australia and New Zealand who present with a cold sore within 48 hours of onset. They will be randomly allocated in a 2:1 ratio to receive either topical Dynamiclear (active) or placebo. Dynamiclear's active ingredients are Hypericum perforatum, Calendula Officinalis and copper sulfate. A single topical treatment of active or placebo will be applied by a pharmacy-based investigator, and participants will be provided with a viral swab kit to confirm presence of herpes virus 1 or 2 from ulcerated lesions. Participants will receive reminders by email and/or SMS to complete an online daily diary assessing their cold sore lesion using a visual guide, and recording other symptoms on numeric scales until healed. The primary outcome variable is median duration of HSL episode in days (participant evaluated) from presentation to return to normal skin. Secondary outcomes include severity of lesion pain, itching, burning and tingling during the symptomatic phase and proportion of lesions progressing to ulceration. ETHICS AND DISSEMINATION Australian ethics approval from Western Sydney University Human Research Ethics Committee, ref: H12776. New Zealand Ethics approval from The Health and Disability Ethics Committees (HDEC) ref: 18/CEN/151. Results will be published in a peer-reviewed academic journal, presented at academic meetings and reported to participants TRIAL REGISTRATION NUMBERS Australia and New Zealand Clinical Trials Registry (ACTRN12618000890235); Universal Trial Number (UTN) (U1111-1233-2426).
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Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: A Controlled Dietary Intervention Study.
Humalda, JK, Yeung, SMH, Geleijnse, JM, Gijsbers, L, Riphagen, IJ, Hoorn, EJ, Rotmans, JI, Vogt, L, Navis, G, Bakker, SJL, et al
The Journal of clinical endocrinology and metabolism. 2020;(9):e3246-56
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CONTEXT Although dietary potassium and sodium intake may influence calcium-phosphate metabolism and bone health, the effects on bone mineral parameters, including fibroblast growth factor 23 (FGF23), are unclear. OBJECTIVE Here, we investigated the effects of potassium or sodium supplementation on bone mineral parameters. DESIGN, SETTING, PARTICIPANTS We performed a post hoc analysis of a dietary controlled randomized, blinded, placebo-controlled crossover trial. Prehypertensive individuals not using antihypertensive medication (n = 36) received capsules containing potassium chloride (3 g/d), sodium chloride (3 g/d), or placebo. Linear mixed-effect models were used to estimate treatment effects. RESULTS Potassium supplementation increased plasma phosphate (from 1.10 ± 0.19 to 1.15 ± 0.19 mmol/L, P = 0.004), in line with an increase in tubular maximum of phosphate reabsorption (from 0.93 ± 0.21 to 1.01 ± 0.20 mmol/L, P < 0.001). FGF23 decreased (114.3 [96.8-135.0] to 108.5 [93.5-125.9] RU/mL, P = 0.01), without change in parathyroid hormone and 25-hydroxy vitamin D3. Fractional calcium excretion decreased (from 1.25 ± 0.50 to 1.11 ± 0.46 %, P = 0.03) without change in plasma calcium. Sodium supplementation decreased both plasma phosphate (from 1.10 ± 0.19 to 1.06 ± 0.21 mmol/L, P = 0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P = 0.02). Urinary and fractional calcium excretion increased (from 4.28 ± 1.91 to 5.45 ± 2.51 mmol/24 hours, P < 0.001, and from 1.25 ± 0.50 to 1.44 ± 0.54 %, P = 0.004, respectively). CONCLUSIONS Potassium supplementation led to a decrease in FGF23, which was accompanied by increase in plasma phosphate and decreased calcium excretion. Sodium supplementation reduced FGF23, but this was accompanied by decrease in phosphate and increase in fractional calcium excretion. Our results indicate distinct effects of potassium and sodium intake on bone mineral parameters, including FGF23. CLINICAL TRIAL REGISTRATION NUMBER NCT01575041.
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The effects of Shilajit supplementation on fatigue-induced decreases in muscular strength and serum hydroxyproline levels.
Keller, JL, Housh, TJ, Hill, EC, Smith, CM, Schmidt, RJ, Johnson, GO
Journal of the International Society of Sports Nutrition. 2019;(1):3
Abstract
BACKGROUND Shilajit is a safe, fluvic mineral complex exudate that is common to Ayurvedic medicine and is composed of fulvic acids, dibenzo-α-pyrones, proteins, and minerals. The purpose of this study was to examine the effects of 8 weeks of Shilajit supplementation at 250 mg·d- 1 (low dose) and 500 mg·d- 1 (high dose) versus placebo on maximal voluntary isometric contraction (MVIC) strength, concentric peak torque, fatigue-induced percent decline in strength, and serum hydroxyproline (HYP). METHODS Sixty-three recreationally-active men ([Formula: see text] ± SD: 21.2 ± 2.4 yr.; 179.8 ± 6.3 cm; 83.1 ± 12.7 kg) volunteered to participate in this study. The subjects were randomly assigned to the high dose, low dose, or placebo group (each group: n = 21). During pre-supplementation testing, the subjects performed 2 pretest MVICs, 2 sets of 50 maximal, bilateral, concentric isokinetic leg extensions at 180°·s- 1 separated by 2-min of rest, and 2 posttest MVICs. Following 8 weeks of supplementation, the subjects repeated the pre-supplementation testing procedures. In addition, the groups were dichotomized at the 50th percentile based on pre-supplementation MVIC and baseline HYP. Mixed model ANOVAs and ANCOVAs were used to statistically analyze the dependent variables for the total groups (n = 21 per group) as well as dichotomized groups. RESULTS For the upper 50th percentile group, the post-supplementation adjusted mean percent decline in MVIC was significantly less for the high dose group (8.9 ± 2.3%) than the low dose (17.0 ± 2.4%; p = 0.022) and placebo (16.0 ± 2.4%; p = 0.044) groups. There was no significant (p = 0.774) difference, however, between the low dose and placebo groups. In addition, for the upper 50th percentile group, the adjusted mean post-supplementation baseline HYP for the high dose group (1.5 ± 0.3 μg·mL- 1) was significantly less than both the low dose (2.4 ± 0.3 μg·mL- 1; p = 0.034) and placebo (2.4 ± 0.3 μg·mL- 1, p = 0.024) groups. CONCLUSIONS The results of the present study demonstrated that 8 weeks of PrimaVie® Shilajit supplementation at 500 mg·d- 1 promoted the retention of maximal muscular strength following the fatiguing protocol and decreased baseline HYP. Thus, PrimaVie® Shilajit supplementation at 500 mg·d- 1 elicited favorable muscle and connective tissue adaptations.
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Improvements in Glycemic, Micronutrient, and Mineral Indices in Arab Adults with Pre-Diabetes Post-Lifestyle Modification Program.
Alfawaz, H, Naeef, AF, Wani, K, Khattak, MNK, Sabico, S, Alnaami, AM, Al-Daghri, NM
Nutrients. 2019;(11)
Abstract
The present study aimed to investigate the changes in dietary patterns of adult Saudis with prediabetes who underwent a six-month lifestyle modification program. A total of 160 Saudis with prediabetes (baseline fasting glucose 5.6-6.9 mmol/L), aged 20-60 years, were enrolled in one of the two arms: A one-time general advice about lifestyle modification (GA group) at orientation or a well-structured and monitored nutrition and lifestyle counseling for six months (guidance group). Fasting blood samples and a dietary recall for daily intakes of macro/micronutrients using a validated computerized food database "ESHA-the Food Processor Nutrition Analysis program" were collected pre- and post-intervention. Compliance to reference daily intake (RDI) was also calculated at both time points. At baseline, overall, severe deficiencies in the majority of micronutrient intakes were observed. Post intervention, clinically significant improvements in the glycemic indices (fasting glucose and insulin resistance) were seen over time in the guidance group. Also, significant improvements in dietary habits and physical activity levels were more apparent in the guidance group than the GA group, particularly in the daily intakes of total carbohydrate (46.9% compliance post vs. 20.3% at baseline); dietary fiber (21.9% vs. 3.1%); and some micronutrients like vitamin B6 (21.3% vs. 6.7%), vitamin B12 (45.3% vs. 28%), vitamin C (21.9% vs. 7.8%), riboflavin (40% vs. 10.7%), niacin (41.3% vs. 14.7%), magnesium (18.8% vs. 4.7%), iron (54.7% vs. 34.4%), and copper (37.3% vs. 13.3%). The study highlights the effects of a six-month lifestyle modification program in improving dietary micronutrient intakes of Saudis with prediabetes. Since micronutrient intake was observed to be low, fortification of these micronutrients in the Saudi diet is recommended.
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Comparative Effects of Cholecalciferol and Calcitriol on Circulating Markers of CKD Mineral Bone Disorder: A Randomized Clinical Trial.
Zelnick, LR, de Boer, IH, Kestenbaum, BR, Chonchol, M, Kendrick, J
Clinical journal of the American Society of Nephrology : CJASN. 2018;(6):927-928
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Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT).
Issa, OM, Roberts, R, Mark, DB, Boineau, R, Goertz, C, Rosenberg, Y, Lewis, EF, Guarneri, E, Drisko, J, Magaziner, A, et al
American heart journal. 2018;:70-77
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IMPORTANCE In a prespecified subgroup analysis of participants not on statin therapy at baseline in the TACT, a high-dose complex oral multivitamins and multimineral regimen was found to have a large unexpected benefit compared with placebo. The regimen tested was substantially different from any vitamin regimen tested in prior clinical trials. OBJECTIVE To explore these results, we performed detailed additional analyses of participants not on statins at enrollment in TACT. DESIGN TACT was a factorial trial testing chelation treatments and a 28-component high-dose oral multivitamins and multiminerals regimen versus placebo in post-myocardial infarction (MI) patients 50 years or older. PARTICIPANTS There were 460 (27%) of 1,708 TACT participants not taking statins at baseline, 224 (49%) were in the active vitamin group and 236 (51%) were in the placebo group. SETTING Patients were enrolled at 134 sites around the United States and Canada. INTERVENTION Daily high-dose oral multivitamins and multiminerals (6 tablets, active or placebo). MAIN OUTCOME The primary end point of TACT was time to the first occurrence of any component of the composite end point: all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for angina. RESULTS The primary end point occurred in 137 nonstatin participants (30%), of which 51 (23%) of 224 were in the active group and 86 (36%) of 236 were taking placebo (hazard ratio, 0.62; 95% confidence interval, 0.44-0.87; P=.006). Results in the key TACT secondary end point, a combination of cardiovascular mortality, stroke, or recurrent MI, was consistent in favoring the active vitamin group (hazard ratio, 0.46; 95% confidence interval, 0.28-0.75; P=.002). Multiple end point analyses were consistent with these results. CONCLUSION AND RELEVANCE High-dose oral multivitamin and multimineral supplementation seem to decrease combined cardiac events in a stable, post-MI population not taking statin therapy at baseline. These unexpected findings are being retested in the ongoing TACT2.
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Effects of Low- and High-Mineral Content Water on the Relative Bioavailability of a Coformulated Abacavir/Dolutegravir/Lamivudine Dispersible Tablet in Healthy Adults.
Singh, RP, Shaik, JSB, Skoura, N, Joshi, S, Shreeves, T, Casillas, L, Buchanan, AM
Journal of acquired immune deficiency syndromes (1999). 2018;(5):631-638
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BACKGROUND The fixed-dose combination (FDC) tablet formulation of abacavir/dolutegravir/lamivudine is indicated for the treatment of HIV-1 infection in adults and pediatric patients weighing ≥40 kg. Alternative formulations with acceptable palatability and convenient dosing are needed for children who require smaller doses and have difficulty swallowing tablets. SETTING A phase 1, open-label, randomized study was conducted in healthy adults to evaluate the relative bioavailability of a novel dispersible FDC tablet of abacavir 150 mg/dolutegravir 10 mg/lamivudine 75 mg administered under 4 different dosing conditions compared with dolutegravir plus abacavir/lamivudine nondispersible, film-coated tablets. METHODS The test treatments were 4 dispersible FDC tablets reconstituted in water with high- or zero-mineral content and administered either immediately or after a 30-minute delay. The reference treatment was 4 nondispersible dolutegravir 10-mg tablets plus 1 nondispersible abacavir 600-mg/lamivudine 300-mg tablet administered with zero-mineral content water. The primary endpoints were area under the concentration-time curve from time 0 extrapolated to infinity and the maximum observed plasma concentration. RESULTS Following administration of dispersible abacavir/dolutegravir/lamivudine, the relative bioavailability of dolutegravir was approximately 50% higher. Abacavir and lamivudine demonstrated bioequivalence when administered as the dispersible FDC tablet compared with coadministration of dolutegravir plus abacavir/lamivudine nondispersible, film-coated tablets. Neither the mineral content of the water nor dosing times affected the pharmacokinetics of individual components. The dispersible tablet was safe and well tolerated, and the palatability was acceptable. CONCLUSIONS These pharmacokinetic results support further development of a dispersible FDC tablet of abacavir/dolutegravir/lamivudine for future use in pediatric patients.
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Follow-up of a randomized trial on postdischarge nutrition in preterm-born children at age 8 y.
Ruys, CA, van de Lagemaat, M, Finken, MJ, Lafeber, HN
The American journal of clinical nutrition. 2017;(2):549-558
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Background: Early nutritional interventions may modulate health risks in preterm-born infants. Previously, we showed that preterm-born infants fed an isocaloric protein- and mineral-enriched postdischarge formula (PDF) from term age to 6-mo corrected age (CA) gained more lean mass than did those fed term formula (TF). Long-term follow-up of randomized nutritional trials is important to test the hypothesis that short-term positive effects on health are sustainable.Objective: The aim of this follow-up study was to compare body size, body composition, and metabolic health at age 8 y in preterm-born children who were randomly assigned to receive either PDF or TF from term age until 6-mo CA.Design: A total of 79 of 152 children (52%) from the original randomized controlled trial were enrolled for follow-up at age 8 y. Weight, height, and head circumference were measured by using standard methods. Body composition, including fat mass, lean mass, bone mineral content, and bone mineral density, was determined by dual-energy X-ray absorptiometry. Blood pressure was measured in the supine position by using an automatic device. Metabolic variables, including glucose, insulin, insulin-like growth factor I, triglycerides, cholesterol, cortisol, and leptin, were measured after an overnight fast. Nutritional habits at age 8 y were assessed by using a 3-d nutritional diary.Results: At age 8 y, no differences were found in body size, body composition, bone variables, and metabolic health variables when comparing children fed PDF with those fed TF. Adjustment for known and possible confounders did not change these results.Conclusions: In this follow-up study in preterm-born children, we showed that the favorable effects of PDF at 6-mo CA either were not maintained or could not be confirmed because of attrition at the age of 8 y. We suggest that future research should focus on nutritional interventions in the pre- and postdischarge period as a continuum rather than as separate entities. This trial was registered at www.trialregister.nl as NTR 2972 (follow-up study [STEP-2 (Study Towards the Effects of Post-discharge Nutrition 2)]) and NTR 55 [original randomized controlled trial (STEP)].
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Effects of Traumeel (Tr14) on Exercise-Induced Muscle Damage Response in Healthy Subjects: A Double-Blind RCT.
Muders, K, Pilat, C, Deuster, V, Frech, T, Krüger, K, Pons-Kühnemann, J, Mooren, FC
Mediators of inflammation. 2016;:1693918
Abstract
The present double-blind, randomized, placebo-controlled clinical trial intended to test whether ingestion of a natural combination medicine (Tr14 tablets) affects serum muscle damage and inflammatory immune response after downhill running. 96 male subjects received Tr14 tablets, which consist of 14 diluted biological and mineral components, or a placebo for 72 h after the exercise test, respectively. Changes in postexercise levels of various serum muscle damage and immunological markers were investigated. The area under the curve with respect to the increase (AUCi) of perceived pain score and creatine kinase (CK) were defined as primary outcome measures. While for CK the p value of the difference between the two groups is borderline, the pain score and muscle strength were not statistically significant. However, a trend towards lower levels of muscle damage (CK, p = 0.05; LDH, p = 0.06) in the Tr14 group was shown. Less pronounced lymphopenia (p = 0.02), a trend towards a lower expression of CD69 count (p = 0.07), and antigen-stimulated ICAM-1 (p = 0.01) were found in the verum group. The Tr14 group showed a tendentially lower increase of neutrophils (p = 0.10), BDNF (p = 0.03), stem cell factor (p = 0.09), and GM-CSF (p = 0.09) to higher levels. The results of the current study indicate that Tr14 seems to limit exercise-induced muscle damage most likely via attenuation of both innate and adaptive immune responses. This study was registered with ClinicalTrials.gov (NCT01912469).
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Effects of Four-Week Supplementation with a Multi-Vitamin/Mineral Preparation on Mood and Blood Biomarkers in Young Adults: A Randomised, Double-Blind, Placebo-Controlled Trial.
White, DJ, Cox, KH, Peters, R, Pipingas, A, Scholey, AB
Nutrients. 2015;(11):9005-17
Abstract
This study explored the effects of four-week multi-vitamin and mineral (MVM) supplementation on mood and neurocognitive function in healthy, young adults. Fifty-eight healthy adults, 18-40 years of age (M = 25.82 years, SD = 4.87) participated in this randomised, double-blind, placebo-controlled trial, in which mood and blood biomarkers were assessed at baseline and after four weeks of supplementation. Compared to placebo, MVM supplementation was associated with significantly lowered homocysteine and increased blood B-vitamin levels (p < 0.01). MVM treatment was also associated with significantly improved mood, as measured by reduced scores on the "depression-dejection" subscale of the Profile of Mood States (p = 0.018). These findings suggest that the four weeks of MVM supplementation may have beneficial effects on mood, underpinned by elevated B-vitamins and lowered homocysteine in healthy young adults.