Dataset Information

A multi-ingredient, pre-workout supplement is apparently safe in healthy males and females.

ABSTRACT:

Background

Pre-workout supplements (PWS) have become increasingly popular with recreational and competitive athletes. While many ingredients used in PWS have had their safety assessed, the interactions when combined are less understood.

Objective

The purpose of this study was to examine the safety of 1 and 2 servings of a PWS.

Design

Forty-four males and females (24.4±4.6 years; 174.7±9.3 cm; 78.9±18.6 kg) from two laboratories participated in this study. Subjects were randomly assigned to consume either one serving (G1; n=14) or two servings (G2; n=18) of PWS or serve as an unsupplemented control (CRL; n=12). Blood draws for safety panels were conducted by a trained phlebotomist before and after the supplementation period.

Results

Pooled data from both laboratories revealed significant group×time interactions (p<0.05) for mean corpuscular hemoglobin (MCH; CRL: 30.9±0.8-31.0±0.9 pg; G1: 30.7±1.1-30.2±0.7 pg; G2: 30.9±1.2-30.9±1.1 pg), MCH concentration (CRL: 34.0±0.9-34.4±0.7 g/dL; G1: 34.1±0.9-33.8±0.6 g/dL; G2: 34.0±1.0-33.8±0.8 g/dL), platelets (CRL: 261.9±45.7-255.2±41.2×10(3)/µL; G1: 223.8±47.7-238.7±49.6×10(3)/µL; G2: 239.1±28.3-230.8±34.5×10(3)/µL), serum glucose (CRL: 84.1±5.2-83.3±5.8 mg/dL; G1: 86.5±7.9-89.7±5.6 mg/dL; G2: 87.4±7.2-89.9±6.6 mg/dL), sodium (CRL: 137.0±2.7-136.4±2.4 mmol/L; 139.6±1.4-140.0±2.2 mmol/L; G2: 139.0±2.2-138.7±1.7 mmol/L), albumin (CRL: 4.4±0.15-4.4±0.22 g/dL; G1: 4.5±0.19-4.5±0.13 g/dL; G2: 4.6±0.28-4.3±0.13 g/dL), and albumin:globulin (CRL: 1.8±0.30-1.8±0.28; G1: 1.9±0.30-2.0±0.31; G2: 1.8±0.34-1.8±0.34). Each of these variables remained within the clinical reference ranges.

Conclusions

The PWS appears to be safe for heart, liver, and kidney function in both one-serving and two-serving doses when consumed daily for 28 days. Despite the changes observed for select variables, no variable reached clinical significance.

SUBMITTER: Joy JM

PROVIDER: S-EPMC4471216 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

A multi-ingredient, pre-workout supplement is apparently safe in healthy males and females.

Joy Jordan M JM Lowery Ryan P RP Falcone Paul H PH Vogel Roxanne M RM Mosman Matt M MM Tai Chih-Yin CY Carson Laura R LR Kimber Dylan D Choate David D Kim Michael P MP Wilson Jacob M JM Moon Jordan R JR

Food & nutrition research 20150616

<h4>Background</h4>Pre-workout supplements (PWS) have become increasingly popular with recreational and competitive athletes. While many ingredients used in PWS have had their safety assessed, the interactions when combined are less understood.<h4>Objective</h4>The purpose of this study was to examine the safety of 1 and 2 servings of a PWS.<h4>Design</h4>Forty-four males and females (24.4±4.6 years; 174.7±9.3 cm; 78.9±18.6 kg) from two laboratories participated in this study. Subjects were rand ...[more]

PMID: 26085481

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Project description:BackgroundThermogenic (TRM) supplements are often used by people seeking to decrease body weight. Many TRM supplements are formulated with multiple ingredients purported to increase energy expenditure and maximize fat loss. However, in the past some TRM ingredients have been deemed unsafe and removed from the market. Therefore, it is important to verify the safety of multi-ingredient TRM supplements with chronic consumption.ObjectiveTo assess the safety of daily consumption of a multi-ingredient TRM supplement over a 28-day period in healthy adults.DesignTwenty-three recreationally active adults (11M, 12F; 27.1±5.4 years, 171.6±9.6 cm, 76.8±16.1 kg, 26±5 BMI) were randomly assigned either to consume a multi-ingredient TRM supplement (SUP; n=9) or remain unsupplemented (CRL; n=14) for 28 days. Participants maintained their habitual dietary and exercise routines for the duration of the study. Fasting blood samples, resting blood pressure, and heart rate were taken before and after the supplementation period. Samples were analyzed for complete blood counts, comprehensive metabolic, and lipid panels.ResultsSignificant (p<0.05) group by time interactions were present for diastolic BP, creatinine, estimated glomerular filtration rate (eGFR), chloride, CO2, globulin, albumin:globulin (A/G), and high-density lipoprotein (HDL). Dependent t-tests conducted on significant variables revealed significant (p<0.05) within-group differences in SUP for diastolic BP (+6.2±5.3 mmHG), creatinine (+0.09±0.05 mg/dL), eGFR (-11.2±5.8 mL/min/1.73), globulin (-0.29±0.24 g/dL), A/G (+0.27±0.23), and HDL (-5.0±5.5 mg/dL), and in CRL for CO2 (-1.9±1.5 mmol/L) between time points. Each variable remained within the accepted physiological range.ConclusionResults of the present study support the clinical safety of a multi-ingredient TRM containing caffeine, green tea extract, and cayenne powder. Although there were statistically significant (p<0.05) intragroup differences in SUP from pre- to postsupplementation for diastolic BP, creatinine, eGFR, globulin, A/G, and HDL, all remained within accepted physiological ranges and were not clinically significant. In sum, it appears as though daily supplementation with a multi-ingredient TRM is safe for consumption by healthy adults for a 28-day period.

Project description:BACKGROUND:The purpose of this study was to examine whether ingesting a pre-workout dietary supplement (PWS) with and without synephrine (S) during training affects training responses in resistance-trained males. METHODS:Resistance-trained males (N?=?80) were randomly assigned to supplement their diet in a double-blind manner with either a flavored placebo (PLA); a PWS containing beta-alanine (3 g), creatine nitrate as a salt (2 g), arginine alpha-ketoglutarate (2 g), N-Acetyl-L-Tyrosine (300 mg), caffeine (284 mg), Mucuna pruiriens extract standardized for 15% L-Dopa (15 mg), Vitamin C as Ascorbic Acid (500 mg), niacin (60 mg), folate as folic acid (50 mg), and Vitamin B12 as Methylcobalamin (70 mg); or, the PWS supplement with Citrus aurantium extract containing 20 mg of synephrine (PWS?+?S) once per day for 8-weeks during training. Participants donated a fasting blood sample and had body composition (DXA), resting heart rate and blood pressure, cognitive function (Stroop Test), readiness to perform, bench and leg press 1 RM, and Wingate anaerobic capacity assessments determined a 0, 4, and 8-weeks of standardized training. Data were analyzed by MANOVA with repeated measures. Performance and cognitive function data were analyzed using baseline values as covariates as well as mean changes from baseline with 95% confidence intervals (CI). Blood chemistry data were also analyzed using Chi-square analysis. RESULTS:Although significant time effects were seen, no statistically significant overall MANOVA Wilks' Lambda interactions were observed among groups for body composition, resting heart and blood pressure, readiness to perform questions, 1RM strength, anaerobic sprint capacity, or blood chemistry panels. MANOVA univariate analysis and analysis of changes from baseline with 95% CI revealed some evidence that cognitive function and 1RM strength were increased to a greater degree in the PWS and/or PWS?+?S groups after 4- and/or 8-weeks compared to PLA responses. However, there was no evidence that PWS?+?S promoted greater overall training adaptations compared to the PWS group. Dietary supplementation of PWS and PWS?+?S did not increase the incidence of reported side effects or significantly affect the number of blood values above clinical norms compared to PLA. CONCLUSION:Results provide some evidence that 4-weeks of PWS and/or PWS?+?S supplementation can improve some indices of cognitive function and exercise performance during resistance-training without significant side effects in apparently health males. However, these effects were similar to PLA responses after 8-weeks of supplementation and inclusion of synephrine did not promote additive benefits. TRIAL REGISTRATION:This trial (NCT02999581) was retrospectively registered on December 16th 2016.

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Dataset Information

A multi-ingredient, pre-workout supplement is apparently safe in healthy males and females.

Background

Objective

Design

Results

Conclusions

Publications

A multi-ingredient, pre-workout supplement is apparently safe in healthy males and females.

Similar Datasets

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